Cumulative Failure Rate Research Articles

Long-Term Outcomes of Anterior Cruciate Ligament Reconstruction Using Either Synthetics With Remnant Preservation or Hamstring Autografts: A 10-Year Longitudinal Study

Background: The optimal graft choice of anterior cruciate ligament (ACL) reconstruction remains controversial. Purpose: To compare the outcomes, especially the long-term cumulative failure rate, of ACL reconstruction using either synthetics with remnant preservation or hamstring autografts (4-strand semitendinosus and gracilis tendons). Study Design: Cohort study; Level of evidence, 2. Methods: A total of 133 patients who underwent ACL reconstruction (synthetics: n = 43; hamstring autografts: n = 90) between July 2004 and December 2007 were included. Questionnaires (Tegner activity scale, Lysholm knee scale, and International Knee Documentation Committee [IKDC] subjective form) were completed preoperatively and at 6 months, 1 year, 5 years, and 10 years postoperatively. The Knee injury and Osteoarthritis Outcome Score (KOOS) was additionally applied at 10 years’ follow-up. The physical examination was based on the 2000 IKDC form. The manual maximum side-to-side difference (KT-1000 arthrometer), single-hop test, thigh muscle atrophy, and joint degeneration (Kellgren and Lawrence classification) were evaluated. The Kaplan-Meier curve and log-rank test (Mantel-Cox, 95% CI) were used to compare graft survivorship. Results: Ten years postoperatively, 111 patients were available, with 38 (88.4%) patients (mean age, 27.6 ± 9.3 years; 28 men) with synthetics and 73 (81.1%) patients (mean age, 28.6 ± 8.8 years; 64 men) with hamstring autografts. Among them, 104 patients (synthetics: n = 35 [81.4%]; hamstring autografts: n = 69 [76.7%]) completed subjective evaluations, and 89 patients (synthetics: n = 30 [69.8%]; hamstring autografts: n = 59 [65.6%]) completed objective evaluations. For hamstring autografts and synthetics, the cumulative failure rates were 8.2% and 7.9%, respectively, and the log-rank test demonstrated no significant difference between the 2 Kaplan-Meier survival curves (P = .910). At 6 months postoperatively, for hamstring autografts and synthetics, the mean Lysholm score was 83.0 ± 7.8 and 88.1 ± 7.5, respectively (P < .001); the mean IKDC score was 83.8 ± 7.8 and 86.9 ± 4.5, respectively (P = .036); and the mean Tegner score was 3.7 ± 1.1 and 5.0 ± 1.5, respectively (P < .001). At 1 year postoperatively, the mean Tegner score was 5.5 ± 1.9 and 6.5 ± 2.0, respectively (P = .011). No statistically significant difference was observed on other subjective evaluation findings, physical examination findings (overall IKDC grade A: 45.8% of hamstring autografts, 50.0% of synthetics), side-to-side difference (1.5 ± 1.5 mm for synthetics, 2.4 ± 2.1 mm for hamstring autografts), single-hop test findings (grade A: 84.7% of hamstring autografts, 93.3% of synthetics), grade A/B thigh muscle atrophy (88.1% of hamstring autografts, 93.3% of synthetics), ipsilateral radiographic osteoarthritis (55.9% of hamstring autografts, 50.0% of synthetics), and graft survivorship. Conclusion: In this prospective cohort study, primary ACL reconstruction using either synthetics with remnant preservation or hamstring autografts showed satisfactory outcomes, especially the long-term cumulative failure rate, at 10 years postoperatively. Patient-reported outcomes suggested that symptom relief and restoration of function might occur earlier in those with synthetics.

Pouch functional outcomes after restorative proctocolectomy with ileal-pouch reconstruction in patients with ulcerative colitis: Japanese multi-center nationwide cohort study.

Although several complications capable of causing pouch failure may develop after restorative proctocolectomy (RPC) for ulcerative colitis (UC), the incidences and causes are conflicting and vary according to country, race and institution. To avoid pouch failure, this study aimed to evaluate the rate of pouch failure and its risk factors in UC patients over the past decade via a nationwide cohort study. We conducted a retrospective, observational, multicenter study that included 13 institutions in Japan. Patients who underwent RPC between January 2005 and December 2014 were included. The characteristics and backgrounds of the patients before and during surgery and their postoperative courses and complications were reviewed. A total of 2376 patients were evaluated over 6.7±3.5years of follow-up. Twenty-seven non-functional pouches were observed, and the functional pouch rate was 98.9% after RPC. Anastomotic leakage (odds ratio, 9.1) was selected as a risk factor for a non-functional pouch. The cumulative pouch failure rate was 4.2%/10years. A change in diagnosis to Crohn's disease/indeterminate colitis (hazard ratio, 13.2) was identified as an independent risk factor for pouch failure. The significant risk factor for a non-functional pouch was anastomotic leakage. The optimal staged surgical procedure should be selected according to a patient's condition to avoid anastomotic failure during RPC. Changes in diagnosis after RPC confer a substantial risk of pouch failure. Additional cohort studies are needed to obtain an understanding of the long-standing clinical course of and proper treatment for pouch failure.

Two year follow-up of Crohn’s patients substituted to certolizumab anti-TNFa therapy: SAVANT 2

The effectiveness of ant-TNF ‘biologic’ therapy in is well supported in the management of moderate to severe Crohn’s Disease (CD). Our first ‘SAVANT’ study was to our knowledge the first study report one- year outcomes in patients (n=60) who switched from previous anti-TNFa treatment to Cimzia/Certolizumab. This current study (SAVANT 2) follows up on longer term outcomes and provides additional clinical and biochemical data that may contribute to therapeutic responses. This IRB approved study was a retrospective analysis of the initial patients included in SAVANT 1. Patients who were switched to TNF antagonist Certolizumab as an alternative biologic were followed an additional year. Retrospective consideration of immunomodulator use, smoking status and clinical data were also evaluated. Of 60 patients with moderate-severe CD who participated in the SAVANT 1 study, 15 patients were excluded due to inadequate follow up. 45 patients were studied for a total of two years following substitution with Certolizumab from prior anti TNF agent therapy. Clinical remission at 1 year was 75% (45/60) and 55% (25/45) at the second year. At the second year, 5 more patients had discontinued Certolizumab due to worse disease or adverse events, indicating a cumulative two-year failure rate of 33% (20/60). Smoking and concomitant use of immunomodulators were similar between ‘success’ and ‘failure’ groups. SAVANT 2, the first study to report long term outcomes of switching from Infliximab or Adalimumab to Certolizumab showed that at 2 years, 25 patient’s maintained clinical remission. The discontinuation rates were 25 and 11% at years 1 & 2 respectively. The 5 patients who lost responsiveness after the first year were women, the majority of smoked. Additional prospective studies to assess the appropriateness and feasibility of biologic substitution are still needed.

Risk factors for failure of the 36 mm metal-on-metal Pinnacle total hip arthroplasty system: a retrospective single-centre cohort study.

AimsTo determine ten-year failure rates following 36 mm metal-on-metal (MoM) Pinnacle total hip arthroplasty (THA), and identify predictors of failure.Patients and MethodsWe retrospectively assessed a single-centre cohort of 569 primary 36 mm MoM Pinnacle THAs (all Corail stems) followed up since 2012 according to Medicines and Healthcare Products Regulation Agency recommendations. All-cause failure rates (all-cause revision, and non-revised cross-sectional imaging failures) were calculated, with predictors for failure identified using multivariable Cox regression.ResultsFailure occurred in 97 hips (17.0%). The ten-year cumulative failure rate was 27.1% (95% confidence interval (CI) 21.6 to 33.7). Primary implantation from 2006 onwards (hazard ratio (HR) 4.30; 95% CI 1.82 to 10.1; p = 0.001) and bilateral MoM hip arthroplasty (HR 1.59; 95% CI 1.03 to 2.46; p = 0.037) predicted failure. The effect of implantation year on failure varied over time. From four years onwards following surgery, hips implanted since 2006 had significantly higher failure rates (eight years 28.3%; 95% CI 23.1 to 34.5) compared with hips implanted before 2006 (eight years 6.3%; 95% CI 2.4 to 15.8) (HR 15.2; 95% CI 2.11 to 110.4; p = 0.007).ConclusionWe observed that 36 mm MoM Pinnacle THAs have an unacceptably high ten-year failure rate, especially if implanted from 2006 onwards or in bilateral MoM hip patients. Our findings regarding implantation year and failure support recent concerns about the device manufacturing process. We recommend all patients undergoing implantation since 2006 and those with bilateral MoM hips undergo regular investigation, regardless of symptoms.Cite this article: Bone Joint J 2017;99-B:592–600.

Long-term Surveillance Following Intralesional Steroid Injection for Benign Vocal Fold Lesions

ImportanceThe short-term outcomes of vocal fold steroid injection (VFSI) are well documented. However, few studies have reported the long-term outcomes following VFSI.ObjectiveTo investigate the incidence rates of symptom recurrence and secondary interventions following VFSI for benign vocal fold lesions.Design, Setting, and ParticipantsThis prospective cohort study was conducted at a tertiary referral medical center in Taipei, Taiwan. The cohort included 189 patients with vocal fold lesions who had received VFSI as the primary treatment between August 2011 and September 2013.ExposuresAll participants underwent VFSI.Main Outcomes and MeasuresLong-term surveillance was conducted through structured telephonic interviews and by reviewing medical charts every 6 months over a 2-year period. We assessed the 10-item voice handicap index, dysphonic symptoms, and whether the patients had received any additional interventions after the initial VFSI.ResultsThe 189 participants (32 men and 157 women; mean [SD] age, 39 [10] years [range, 20-74 years] included patients who had undergone VFSI for vocal fold nodules (n = 72), polyps (n = 72), or mucus-retention cysts (n = 45). Following VFSI, 141 patients (74.6%; 23 men and 118 women; mean age, 39 years [range, 20-70 years]) showed positive response (ie, clinically significant symptom resolution without the need for additional procedures) and received long-term surveillance. The median follow-up period was 19.4 months, and 2 patients were lost to follow-up postoperatively within 1 year. The cumulative failure rates (subjective symptom recurrence plus secondary treatments) at 6, 12, 18, and 24 months after VFSI were 12%, 17%, 24%, and 32%, respectively. When the initial response rate to VFSI (141 of 189, 74.6%) was considered altogether, VFSI remained effective after 2 years in 50% of the initially recruited 189 patients. The highest rate of long-term effectiveness of VFSI occurred in vocal polyps (54%), followed by nodules (49%) and cysts (43%).Conclusions and RelevanceThis study demonstrates that VFSI can be beneficial in managing benign vocal lesions, especially when first-line treatments are unsuitable. However, the long-term results of this study clarify that a substantial number of patients experience symptom recurrence or receive subsequent interventions within 2 years after VFSI; this should be considered in medical decision making.

Immunologic treatment failure among HIV-infected adult patients in Jiangsu province, China

The National Free Antiretroviral Treatment Program was implemented in Jiangsu Province, China in 2005. We conducted a retrospective, open cohort study to determine treatment failure rates and associated risk factors. Data were obtained from the national web-based antiretroviral treatment database. WHO criteria were used to define immunologic treatment failure. Kaplan-Meier methods were used to determine treatment failure rates and Cox proportional hazards modeling was used to identify risk factors. A total of 5,083 (87.8%) having at least one CD4 cell count measure were included from 2005 to 2013. Overall, 30.4% had immunologic treatment failure with cumulative treatment failure rates increasing to 50.5% at month 60 and 64.1% at month 90. Factors predicting treatment failure included being treated in the Centers for Disease Control and Prevention system (HR 1.69, 95% CI 1.14–2.50, p = 0.009) or jail hospital (HR 1.20, 95% CI 1.08–1.34, p = 0.001), and having a baseline CD4 count >350 cells/uL (HR 2.37, 95% CI 1.94–2.89. p < 0.001). Immunologic treatment failure was moderate to substantial among treated HIV patients. Providing second-line regimens and shifting treatment providers to professional hospitals should be considered to consolidate gains in averting morbidity and mortality.

Clinical outcomes of a real-world cohort following bioresorbable vascular scaffold implantation utilising an optimised implantation strategy

It has become apparent that, in comparison to metallic stents, bioresorbable vascular scaffolds (BVS) require specific implantation techniques. The aim of this study was to investigate outcomes following BVS implantation using a dedicated strategy for optimal deployment. Four hundred consecutive lesions (264 patients) treated with the Absorb BVS were analysed. All procedures were performed based on the following principles: 1) aggressive lesion preparation; 2) high-pressure post-dilation; and 3) a low threshold for intravascular imaging. The majority of target lesions (74.8%) were type B2 or C lesions. Predilation (97.3%) and post-dilation (99.8%) were performed in almost all cases. The mean post-dilation pressure was 21±5 atm, and the total scaffold length per patient was 53.2±32.5 mm. Intravascular imaging was performed in the majority of cases (85.8%) and, when utilised after post-dilatation, a further intervention was required in 24.5% of lesions. The cumulative target lesion failure rates were 7.9% at one year and 11.6% at two years. Definite/probable scaffold thrombosis occurred in three patients (1.2% at one and two years). Clinical outcomes following implantation of current-generation BVS, in a real-world population with a high prevalence of complex lesions, were acceptable when utilising our optimised implantation strategy.

Five-Year Pooled Data Analysis of the Ahmed Baerveldt Comparison Study and the Ahmed Versus Baerveldt Study

To determine the relative efficacy of the Ahmed-FP7 and Baerveldt BG101-350 implants. Pooled analysis of 2 multicenter, randomized clinical trials. A total of 514 patients aged 18 or older with uncontrolled glaucoma that had failed or were at high risk of failing trabeculectomy were randomized to receive an Ahmed implant (n= 267) or Baerveldt implant (n= 247). Cumulative failure rates (using an intraocular pressure [IOP] target of 6-18mm Hg inclusive), de novo glaucoma surgery rates, mean IOP, mean glaucoma medication use, and visual acuity were compared. Baseline characteristics were similar between groups. Mean preoperative IOP of the study population was 31.5 ± 11.3mm Hg on an average of 3.3 ± 1.1 glaucoma medications. At 5 years, mean IOP was 15.8 ± 5.2mm Hg in the Ahmed group and 13.2 ± 4.7mm Hg in the Baerveldt group (P < .001). Mean glaucoma medication use was 1.9 ± 1.5 in the Ahmed group and 1.5 ± 1.4 in the Baerveldt group (P= .007). The cumulative failure rate at 5 years was 49% in the Ahmed group and 37% in the Baerveldt group (P= .007). High IOP was the most common reason for failure in both groups, and de novo glaucoma surgery was required in 16% of the Ahmed group and 8% of the Baerveldt group (P= .006). Failure owing to hypotony occurred in 0.4% of the Ahmed group and 4.5% of the Baerveldt group (P= .002). Visual outcomes were similar between groups (P= .90). The Baerveldt group had a lower failure rate, lower rate of de novo glaucoma surgery, and lower mean IOP on fewer medications than the Ahmed group. Baerveldt implantation carried a higher risk of hypotony.

Risk assessment using interval vector cumulative failure rate

Risk management is a process to identify, assess, and mitigate potential risks to the success of a project. Risks that are not handled appropriately can result in a catastrophe, such as the Space Shuttle Challenger explosion. In this study, a method of using interval vector of cumulative failure rates was developed to improve the categorisation of risks. The cause of the Challenger accident was explored and design failures explained. An illustrative example will be presented to demonstrate the use of newly developed method on the space shuttle solid rocket booster field joint.

Risk assessment using interval vector cumulative failure rate

Risk assessment using interval vector cumulative failure rate

Randomized controlled Phase III study comparing hepatic arterial infusion with systemic chemotherapy after curative resection for liver metastasis of colorectal carcinoma: JFMC 29–0003

The feasibility and efficacy of adjuvant hepatic arterial infusion (HAI) in preventing the development of liver metastases in patients with advanced colon carcinoma have not been validated. The aim of this randomized controlled study was to compare the feasibility of HAI and the protective effect against liver metastasis after curative resection to those of systemic chemotherapy. Between July 2000 and June 2003, 91 patients were enrolled. Patients were randomly assigned to receive 5-fluorouracil (5-FU) via continuous venous infusion (CVI) or intra-hepatic arterial weekly high-dose 5-FU (WHF). The primary endpoint was overall survival (OS). In the WHF group, the cumulative failure rate of hepatic arterial catheterization was 16.7% at 6 months. The occurrence of grade 3 adverse events was comparable between the groups. The 5-year OS rates were 59.0% in the CVI group and 34.9% in the WHF group (P = 0.164). CVI tended to show a protective effect against liver metastasis regarding the 5-year liver-specific cumulative recurrence rate: CVI, 45.0% vs. WHF, 68.3%; P = 0.037). HAI therapy has a certain protective effect against liver metastasis after curative resection in patients with colorectal cancer. However, this therapy did not contribute to any marked improvement in their overall survival.

A single-arm phase III study exploring the efficacy and safety of LNG-IUS 8, a low-dose levonorgestrel intrauterine contraceptive system (total content 13.5 mg), in an Asia-Pacific population

ObjectiveThe objective was to evaluate the efficacy and safety of a low-dose levonorgestrel intrauterine system with total content 13.5 mg (average approximately 8 μg/24 h over the first year; LNG-IUS 8; Jaydess®) in an Asia-Pacific population. Study designAn open-label, single-arm phase III study conducted at 25 centers in China, Australia and Korea assessed LNG-IUS 8 use over 3 years in nulliparous and parous women (N=1114) aged 18–40 years with regular menstrual cycles (21–35 days). Primary outcome was pregnancy rate, expressed as the Pearl Index. Secondary outcomes included 3-year cumulative failure rate, treatment-emergent adverse events (TEAEs), discontinuation rate, bleeding profile and placement pain. ResultsThe full analysis set comprised 925 women (mean age 31.6 years, 6.4% nulliparous). Overall unadjusted Pearl Index was 0.35 (95% confidence interval 0.15–0.70); the 3-year cumulative failure rate was 0.9% (95% confidence interval 0.4–1.9). TEAEs and study drug-related TEAEs were reported in 70.1% and 31.2% of women, respectively. Overall, 27.9% of women discontinued the study, 16.9% due to adverse events. Frequent or prolonged bleeding (World Health Organization criteria) decreased from the first to the twelfth 90-day reference intervals (from 5.0% to 0.7% and from 44.1% to 3.0%, respectively), and the percentage of women with amenorrhea increased over time (from 0.4% to 10.8%). Pain on placement was reported as “none” or “mild” in 91.9% of women. ConclusionsLNG-IUS 8 was an effective and well-tolerated contraceptive method, providing another option for women in the Asia-Pacific region. ImplicationsIn this phase III study, LNG-IUS 8 was shown to be highly effective and well tolerated in an Asia-Pacific population and was not associated with any new or unexpected safety events. LNG-IUS 8 provides another contraceptive option for women in the Asia-Pacific region.

Evaluation of a new, low-dose levonorgestrel intrauterine contraceptive system over 5 years of use

ObjectiveTo evaluate the efficacy and safety of a new, low-dose levonorgestrel intrauterine contraceptive system (LNG-IUS 12) for up to 5 years of use. Study designIn this Phase III study, 2885 nulliparous and parous women aged 18–35 years were randomized to LNG‐IUS 8 or LNG-IUS 12 for 3 years. After 3 years, women using LNG-IUS 12 could continue for up to 2 additional years (5 years total). The primary outcome was occurrence of pregnancy (Pearl Index). Secondary outcomes included safety, bleeding, dysmenorrhea, discontinuations, and user satisfaction. ResultsFrom August 2007 through May 2008, out of 2885 women who were enrolled, 1453 were randomized to LNG-IUS 12. Placement was attempted in 1452/1453 (full analysis set). Mean age at baseline was 27.1 years; 39.5% were nulliparous. The cumulative 5-year Pearl Index (PI) was 0.29; the 5-year cumulative failure rate was 1.4%. The 5-year PI for ectopic pregnancy was 0.18. Over 5 years, 55.3% of women reported study drug-related treatment-emergent adverse events (TEAEs). Crude incidences of pelvic inflammatory disease, uterine perforation, and complete/partial LNG-IUS 12 expulsion were 0.6%, 0.2%, and 3.7%, respectively. Women using LNG-IUS 12 generally experienced less frequent bleeding over time. The incidence of amenorrhea during the last 90-day reference interval (end of Year 5) was 22.6%. Overall, 870 (59.9%) and 550 (37.9%) women completed 3 and 5 years of treatment, respectively; 77.8% of women who entered the extension phase completed 5 years of use. Over 5 years, 22.6% discontinued due to TEAEs, including 13 women who discontinued due to pregnancy; 76 discontinued due to bleeding problems including amenorrhea; and 163 discontinued due to desire for pregnancy, 71.2% of whom conceived within 12 months. ConclusionIn this study including parous and nulliparous women, LNG-IUS 12 was highly effective over 5 years of use and associated with a favorable safety profile. LNG‐IUS 12 offers women a low-dose contraceptive option for up to 5 years.

Keeping kids in care: virological failure in a paediatric antiretroviral clinic and suggestions for improving treatment outcomes

The burden of paediatric HIV in South Africa is extremely high. Antiretrovirals (ARVs) are now widely accessible in the country and the clinical emphasis has shifted from initiation of treatment to retention in care. This study describes the cumulative virological failure rate amongst children on ARVs in a peri-urban clinic, and suggests ways in which clinics and partners could improve treatment outcomes. The study was conducted by the non-profit organisation HOPE Cape Town Association. A retrospective file audit determined the cumulative virological failure rate, that is, the sum of all children with a viral load >1000 copies/ml, children on monotherapy, children who had stopped treatment, children lost to follow-up (LTFU) and children who had died. Interviews were conducted with a purposive sample of 12 staff members and a random sample of 21 caregivers and 4 children attending care. Cumulative virological failure rate was 42%, with most of those children having been LTFU. Both staff and caregivers consistently identified pharmacy queues, ongoing stigma and unpalatable ARVs as barriers to adherence. Staff suggestions included use of adherence aids, and better education and support groups for caregivers. Caregivers also requested support groups, as well as “same day” appointments for caregivers and children, but rejected the idea of home visits. Simple, acceptable and cost-effective strategies exist whereby clinics and their partners could significantly reduce the cumulative virological failure rate in paediatric ARV clinics. These include actively tracing defaulters, improving education, providing support groups, and campaigning for palatable ARV formulations.

Parylene MEMS patency sensor for assessment of hydrocephalus shunt obstruction.

Neurosurgical ventricular shunts inserted to treat hydrocephalus experience a cumulative failure rate of 80% over 12years; obstruction is responsible for most failures with a majority occurring at the proximal catheter. Current diagnosis of shunt malfunction is imprecise and involves neuroimaging studies and shunt tapping, an invasive measurement of intracranial pressure and shunt patency. These patients often present emergently and a delay in care has dire consequences. A microelectromechanical systems (MEMS) patency sensor was developed to enable direct and quantitative tracking of shunt patency in order to detect proximal shunt occlusion prior to the development of clinical symptoms thereby avoiding delays in treatment. The sensor was fabricated on a flexible polymer substrate to eventually allow integration into a shunt. In this study, the sensor was packaged for use with external ventricular drainage systems for clinical validation. Insights into the transduction mechanism of the sensor were obtained. The impact of electrode size, clinically relevant temperatures and flows, and hydrogen peroxide (H2O2) plasma sterilization on sensor function were evaluated. Sensor performance in the presence of static and dynamic obstruction was demonstrated using 3 different models of obstruction. Electrode size was found to have a minimal effect on sensor performance and increased temperature and flow resulted in a slight decrease in the baseline impedance due to an increase in ionic mobility. However, sensor response did not vary within clinically relevant temperature and flow ranges. H2O2 plasma sterilization also had no effect on sensor performance. This low power and simple format sensor was developed with the intention of future integration into shunts for wireless monitoring of shunt state and more importantly, a more accurate and timely diagnosis of shunt failure.

Abstract: Outcomes in Reconstruction of Composite Scalp and Calvarial Defects – Revisiting the Role of Alloplastic Cranioplasty in High Risk Patients

INTRODUCTION: Advances in cranioplasty have enabled repair of increasingly complex defects.1–4 This led to widespread use of alloplastic materials in high-risk patients, including those with previous history of osteomyelitis, radiation, frontal sinus involvement, and soft–tissue deficits. The long-term outcomes of these reconstructions have been largely understudied. The aim of this study was to evaluate the natural history of cranioplasty in high-risk patients with soft-tissue defects requiring flap coverage. MATERIALS AND METHODS: A retrospective review of patients treated with 466 cranioplasties between 2002 and 2014 was performed. RESULTS: Materials used for reconstructions included non-titanium alloplastic cranioplasty in 52% (n=243), titanium mesh in 38% (n=177), and autologous bone in 10% (n=46). Mean cranial defect size was 59 ± 60cm2. Sixteen percent (n=74) of the reconstructions included full-thickness scalp defect with a mean area of 22 ± 74cm2. Mean follow-up was 3.9 ± 3.0 years. Cumulative revision rate was 22% (n=104) and the cumulative reconstructive failure rate (defined as removal of the cranioplasty) was 13% (n=60). When soft-tissue reconstruction was needed, 2-year failure rate for autologous bone was 14%, for non-titanium alloplastic cranioplasty 29%, and for titanium mesh 39%. At the end of follow-up, failure rate remained stable for autologous bone – 14%, and for non-titanium alloplastic cranioplasty – 37% (p>0.05). The failure rate for titanium mesh continued to increase over time to 53% (p<0.05). CONCLUSION: Simultaneous scalp and calvarial reconstruction is associated with significantly worse outcomes than calvarial reconstruction alone. Composite reconstruction with a locoregional flap and alloplastic cranioplasty, in particular titanium mesh, is associated with surprisingly high failure rate of over 50% and should be either discouraged, or used as a temporary treatment until more permanent coverage option is available. We advocate the use of autogenous tissues in these scenarios to achieve more durable repairs. If this is not an option and alloplastic material needs to be utilized, scalp reconstruction with a free tissue transfer should be done early as it yields better results than a locoregional flap. DISCLOSURE/FINANCIAL SUPPORT:The authors have no financial interest to declare in relation to the content of this manuscript. REFERENCES: 1. Chao AH, Yu P, Skoracki RJ, Demonte F, Hanasono MM. Microsurgical reconstruction of composite scalp and calvarial defects in patients with cancer: a 10-year experience. Head Neck. 2012;12:1759–1764 2. Afifi A, Djohan RS, Hammert W, Papay FA, Barnett AE, Zins JE. Lessons learned reconstructing complex scalp defects using free flaps and a cranioplasty in one stage. J Craniofac Surg. 2010;4:1205–1209 3. St–Hilaire H, Mithani SK, Taylor J, Simmons OP, Singh N, Rodriguez ED. Restoring the failed cranioplasty: nonanatomical titanium mesh with perforator flap. Plast Reconstr Surg. 2009;123:1813–1817 4. Wang HT, Erdmann D, Olbrich KC, Friedman AH, Levin LS, Zenn MR. Free flap reconstruction of the scalp and calvaria of major neurosurgical resection in cancer patients: lessons learned closing large, difficult wounds of the dura and skull. Plast Reconstr Surg. 2007;119:865–872

The Ahmed Versus Baerveldt Study: Five-Year Treatment Outcomes

To compare 2 frequently used aqueous shunts for the treatment of glaucoma. International, multicenter, randomized trial. Patients aged 18 years or older with uncontrolled glaucoma despite maximum tolerated medical therapy, many of whom had failed or were at high risk of failing trabeculectomy. Eligible patients were randomized to receive an Ahmed-FP7 valve implant (New World Medical, Inc, Rancho Cucamonga, CA) or a Baerveldt-350 implant (Abbott Medical Optics, Inc, Santa Ana, CA) using a standardized surgical technique. The primary outcome was failure, defined as intraocular pressure (IOP) outside the target range (5-18 mmHg) or reduced <20% from baseline for 2 consecutive visits after 3 months, severe vision loss, or de novo glaucoma surgery. Secondary outcomes measures included IOP, medication use, visual acuity, complications, and interventions. A total of 238 patients were randomized; 124 received the Ahmed-FP7 implant, and 114 received the Baerveldt-350 implant. Baseline characteristics were similar between groups. Mean preoperative IOP was 31.4±10.8 mmHg on 3.1±1.0 glaucoma medications. At 5 years, the cumulative failure rate was 53% in the Ahmed group and 40% in the Baerveldt group (P= 0.04). The main reason for failure in both groups was high IOP, and the cumulative de novo glaucoma reoperation rate was 18% in the Ahmed group and 11% in the Baerveldt group (P= 0.22). Hypotony resulted in failure in 5 patients (4%) in theBaerveldt group compared with none in the Ahmed group (P= 0.02). Mean IOP was 16.6±5.9 mmHg in the Ahmed group (47% reduction) and 13.6±5.0 mmHg in the Baerveldt group (57% reduction, P= 0.001). Mean medication use was 1.8±1.5 mmHg in the Ahmed group (44% reduction) and 1.2±1.3 mmHg in the Baerveldt group (61% reduction, P= 0.03). The 2 groups had similar complication rates (Ahmed 63%, Baerveldt 69%) and intervention rates (Ahmed 41%, Baerveldt 41%). Most complications were transient, and most interventions were slit-lamp procedures. Both implants were effective in reducing IOP and the need for glaucoma medications. The Baerveldt group had a lower failure rate and a lower IOP on fewer medications than the Ahmed group, but had a small risk of hypotony that was not seen in the Ahmed group.

Comparative study of the failure rates among 3 implantable defibrillator leads

After the introduction of the Biotronik Linox S/SD high-voltage lead, several cases of early failure have been observed. The purpose of this article was to assess the performance of the Linox S/SD lead in comparison to 2 other contemporary leads. We used the prospective Erasmus MC ICD registry to identify all implanted Linox S/SD (n = 408), Durata (St. Jude Medical, model 7122) (n = 340), and Endotak Reliance (Boston Scientific, models 0155, 0138, and 0158) (n = 343) leads. Lead failure was defined by low- or high-voltage impedance, failure to capture, sense or defibrillate, or the presence of nonphysiological signals not due to external interference. During a median follow-up of 5.1 years, 24 Linox (5.9%), 5 Endotak (1.5%), and 5 Durata (1.5%) leads failed. At 5-year follow-up, the cumulative failure rate of Linox leads (6.4%) was higher than that of Endotak (0.4%; P < .0001) and Durata (2.0%; P = .003) leads. The incidence rate was higher in Linox leads (1.3 per 100 patient-years) than in Endotak and Durata leads (0.2 and 0.3 per 100 patient-years, respectively; P < .001). A log-log analysis of the cumulative hazard for Linox leads functioning at 3-year follow-up revealed a stable failure rate of 3% per year. The majority of failures consisted of noise (62.5%) and abnormal impedance (33.3%). This study demonstrates a higher failure rate of Linox S/SD high-voltage leads compared to contemporary leads. Although the mechanism of lead failure is unclear, the majority presents with abnormal electrical parameters. Comprehensive monitoring of Linox S/SD high-voltage leads includes remote monitoring to facilitate early detection of lead failure.

Proton Beam Therapy for Localized Prostate Cancer: Results from a Prospective Quality-of-Life Trial.

To report prostate cancer outcomes, toxicity, and quality of life (QOL) in men treated with proton beam therapy (PBT). Patients were enrolled in a prospective trial. All participants received 75.6 to 78 Gy (RBE). Up to 6 months of luteinizing hormone-releasing hormone agonist therapy was allowed. The Phoenix definition defined biochemical failure. Modified Radiation Therapy Oncology Group criteria defined toxicity. Expanded Prostate Cancer Index Composite questionnaires objectified QOL. Clinically significant QOL decrement was defined as ≥0.5 × baseline standard deviation. In total, 423 men were analyzed. The National Comprehensive Cancer Network risk classification was used (low 43%; intermediate 56%; high 1%). At the 5.2-year median follow-up, overall and disease-specific survival rates were 99.8% and 100%, respectively. Cumulative biochemical failure rate was 5.2% (95% confidence interval [CI] = 3.0%-8.3%); acute grade 2 genitourinary (GU) toxicity was 46.3%; acute grade 2 gastrointestinal (GI) toxicity was 5.0% (95% CI = 3.1%-7.3%). There was no acute grade ≥3 GI or GU toxicity. Cumulative late grade 2 GU and GI toxicity was 15.9% (95% CI = 13%-20%) and 9.7% (95% CI = 6.5%-12%), respectively. There were 2 grade 3 late GI toxicities (rectal bleeding) and no late grade ≥3 GU toxicity. The 4-year mean Expanded Prostate Cancer Index Composite urinary, bowel, sexual, and hormonal summary scores (range; standard deviation) were 89.7 (43.8-100; 11), 91.3 (41.1-94.6; 10), 57.8 (0.0-96.2; 27.1), and 92.2 (25-95.5; 10.5), respectively. Compared with baseline, there was no clinically significant decrement in urinary, sexual, or hormonal QOL after treatment completion. A modest (<10 points), yet clinically significant, decrement in bowel QOL was appreciated throughout follow-up. Contemporary PBT resulted in excellent biochemical control, minimal risk of higher-grade toxicity, and modest QOL decrement. Further investigation comparing PBT with alternative prostate cancer treatment strategies are warranted.

Confirmation Testing of Essure Microinserts in Unintended Pregnancies Using a 10-Year Retrospective Database

Study ObjectivesTo examine the imaging modality used in cases of Essure failures and determine the cause of the unintended pregnancies (noncompliance to follow-up recommendations, misinterpretation of the imaging test, or device failure). DesignRetrospective, single-center interventional cohort (Canadian Task Force classification II-2). SettingTertiary level hospital. PatientsWomen who have had Essure placement and subsequent pregnancy. InterventionsCoding data from the Regina General Hospital was examined for any pregnancy occurring after an Essure procedure. The hospital charts were then reviewed for data collection. A separate imaging database established over the same time frame was then reviewed to determine the imaging modality used in each case (transvaginal ultrasound [TVU], hysterosalpingogram [HSG], or none). Results of the imaging study were reviewed and the cause of the failure determined. Measurements and Main ResultsTwenty-four pregnancies in 25 women were identified after Essure procedures from January 1, 2003 to March 31, 2013. There were 4 in vitro fertilization pregnancies and 4 pregnancies where the woman had been instructed not to rely on the devices because of incomplete placement noted at time of the procedure. Therefore, 17 unintended pregnancies occurred of a total 2080 procedures performed. Examination of the imaging studies revealed that 11 were due to patient noncompliance (either early cessation of backup contraception or failure to go for confirmatory imaging), 5 due to misinterpretation of the imaging tests (3 HSG, 2 TVU), and 1 device failure. This reveals a cumulative failure rate of 6 of 2080 or .29% over 10 years with only .04% (1/2080) being device related. ConclusionEssure sterilization is an effective means of permanent contraception with a device failure rate of only .04%. Most unintended pregnancies after the Essure procedure result from a failure to comply with follow-up recommendations, and strategies to improve compliance should be emphasized.