High-intensity focused ultrasound with visually directed power adjustment for focal treatment of localized prostate cancer: systematic review and meta-analysis.

PURPOSE: To characterize patient outcomes following visually directed high-intensity focused ultrasound (HIFU) for focal treatment of localized prostate cancer. METHODS: We performed a systematic review of cancer-control outcomes and complication rates among men with localized prostate cancer treated with visually directed focal HIFU. Study outcomes were calculated using a random-effects meta-analysis model. RESULTS: A total of 8 observational studies with 1,819 patients (median age 67 years; prostate-specific antigen 7.1 mg/ml; prostate volume 36 ml) followed over a median of 24 months were included. The mean prostate-specific antigen nadir following visually directed focal HIFU was 2.2 ng/ml (95% CI 0.9-3.5 ng/ml), achieved after a median of 6 months post-treatment. A clinically significant positive biopsy was identified in 19.8% (95% CI 12.4-28.3%) of cases. Salvage treatment rates were 16.2% (95% CI 9.7-23.8%) for focal- or whole-gland treatment, and 8.6% (95% CI 6.1-11.5%) for whole-gland treatment. Complication rates were 16.7% (95% CI 9.9-24.6%) for de novo erectile dysfunction, 6.2% (95% CI 0.0-19.0%) for urinary retention, 3.0% (95% CI 2.1-3.9%) for urinary tract infection, 1.9% (95% CI 0.1-5.3%) for urinary incontinence, and 0.1% (95% CI 0.0-1.4%) for bowel injury. CONCLUSION: Limited evidence from eight observational studies demonstrated that visually directed HIFU for focal treatment of localized prostate cancer was associated with a relatively low risk of complications and acceptable cancer control over medium-term follow-up. Comparative, long-term safety and effectiveness results with visually directed focal HIFU are lacking.

Effect of aerobic exercise on erectile function: systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: The health benefits of regular aerobic exercise are well established, although there is limited high-quality evidence regarding its impact on erectile function. AIM: To determine the effect of aerobic exercise on erectile function in men and to identify factors that may influence this effect. METHODS: This systematic review and meta-analysis included randomized controlled trials that evaluated the effects of aerobic exercise on erectile function via the Erectile Function domain of the International Index of Erectile Function (IIEF-EF). The mean difference in IIEF-EF scores between the aerobic exercise and nonexercising control groups was estimated by a random-effects meta-analysis. Meta-regression was used to evaluate the association of moderator variables on meta-analysis results. OUTCOMES: The IIEF-EF score is reported on a 6-30 scale, with higher values indicating better erectile function. RESULTS: Among 11 randomized controlled trials included in the analysis, aerobic exercise resulted in statistically significant improvements in IIEF-EF scores as compared with controls, with a mean difference of 2.8 points (95% CI, 1.7-3.9; P < .001) and moderate heterogeneity among studies (I2 = 53%). The effect of aerobic exercise on erectile function was greater in men with lower baseline IIEF-EF scores, with improvements of 2.3, 3.3, and 4.9 points for mild, moderate, and severe erectile dysfunction, respectively (P = .02). The meta-analysis results were not influenced by publication bias or individual study effects. CLINICAL IMPLICATIONS: Health care providers should consider recommending regular aerobic exercise as a low-risk nonpharmacologic therapy for men experiencing erectile difficulties. STRENGTHS AND LIMITATIONS: The primary strength of this review was the generation of level 1 evidence on a topic of general interest regarding sexual health in men. However, the included studies evaluated diverse groups, which may complicate data interpretation for specific segments of the population. CONCLUSION: Regular aerobic exercise can improve the erectile function of men, particularly those with lower baseline IIEF-EF scores.

Surgical Reintervention Rate after Prostatic Urethral Lift: Systematic Review and Meta-Analysis Involving over 2,000 Patients.

PURPOSE: The surgical reintervention rate after prostatic urethral lift is not well characterized but has been estimated at 2% to 3% per year. We performed a systematic review and meta-analysis to determine the surgical reintervention rate after prostatic urethral lift. MATERIALS AND METHODS: We systematically searched MEDLINE®, Embase® and the Cochrane Central Register of Controlled Trials for studies of men treated with prostatic urethral lift reporting at least 1 year of maximum followup data. We performed a random effects meta-analysis to estimate the annual rate of surgical reintervention after prostatic urethral lift, including those performed for lower urinary tract symptoms or involving device explant, additions or replacement. The robustness of the meta-analysis conclusions was evaluated in a one-study removed analysis and heterogeneity was investigated with a subgroup analysis. RESULTS: In 11 studies (2,016 patients) 153 surgical reinterventions were performed, among which transurethral resection of the prostate/laser (51.0%), repeat prostatic urethral lift (32.7%) and device explant (19.6%) were most common. The annual rate of surgical reintervention was 6.0% per year (95% CI 3.0-8.9). These results were not significantly influenced by any single study. The annual rate of surgical intervention was significantly influenced by the mean duration of patient followup. Surgical reintervention rates were 4.3% per year in studies with 1 year or less mean followup, 10.7% per year in studies with more than 1 year to 3 years mean followup and 5.8% per year in a single study with more than 3 years mean followup (p=0.04). CONCLUSIONS: The surgical reintervention rate with prostatic urethral lift is 6.0% per year and is higher in studies with longer followup durations.

Six-Month Results of Selective Bladder Denervation in Women with Refractory Overactive Bladder.

PURPOSE: We report 6-month efficacy and safety outcomes of selective bladder denervation in women with refractory overactive bladder. MATERIALS AND METHODS: Women with refractory overactive bladder and urgency urinary incontinence were enrolled in 2 prospective feasibility studies with the same entry criteria. They underwent selective bladder denervation of the subtrigonal region containing afferent sensory nerves. Patients were followed for 6 months and assessed for adverse events, overactive bladder symptoms and health related quality of life measures. RESULTS: In the 35 women with a mean age of 66 years who were enrolled in the study all selective bladder denervation procedures were completed successfully. During 6 months of followup the symptom improvement based on 3-day bladder diaries was 59% for urgency urinary incontinence (p <0.001), 59% for urinary incontinence (p <0.001), 39% for urgency (p <0.001), 9% for urinary frequency (p = 0.01) and 27% for the total urgency and frequency score (p <0.001). Most of this treatment benefit was realized in the first month. The rate of clinical success, defined as a 50% or greater reduction in urgency urinary incontinence, was 70%, treatment benefit was reported in 75% of patients and the dry/cure rate was 27%. Statistically significant improvements during 6 months were identified on the symptom bother and health related quality of life scales on the OAB-q (Overactive Bladder Questionnaire) and on all KHQ (King's Health Questionnaire) domains except general health perception. Device or procedure related adverse events were reported in 6 patients (17%). CONCLUSIONS: Pooled results of 2 prospective feasibility studies suggest that selective bladder denervation is a promising minimally invasive treatment option in women with refractory overactive bladder.

Initial clinical experience with selective bladder denervation for refractory overactive bladder.

AIMS: To report the initial clinical experience with selective bladder denervation (SBD) of the trigone in women with refractory overactive bladder (OAB). METHODS: Females with refractory OAB underwent SBD of the bladder sub-trigone region. Patients were treated using a 10-s voltage-controlled radiofrequency (RF) algorithm (RF10) at study onset. The protocol was modified during the study after which point remaining patients received 60-s temperature-controlled RF (RF60). Patients were followed for 12 weeks and evaluated for adverse events and changes in OAB symptoms. Exploratory analyses on the influence of RF duration were performed. RESULTS: Among 63 patients, SBD resulted in statistically significant and clinically important improvements for most outcomes. Comparing RF10 (n = 34) to RF60 (n = 29), treatment benefit was greater with RF60 including mean reduction in urgency urinary incontinence (-2.5 vs -0.9; P < 0.01), urinary incontinence (-2.6 vs -0.8; P < 0.001), and total urgency and frequency score (-13 vs -7; P = 0.02); and improvements in symptom bother (-33 vs -18; P < 0.01) and quality of life (28 vs 16; P = 0.02) on the OAB questionnaire. The proportion of urgency urinary incontinence treatment responders (≥50% reduction in episodes) was 79% with RF60 and 31% with RF10. The frequency of device- or procedure-related adverse events was comparable in RF10 versus RF60 groups (14.7% vs 17.2%). CONCLUSIONS: This study demonstrated the feasibility of SBD in alleviating symptoms of refractory OAB. A 60-s RF algorithm using deeper ablations of the sub-trigonal tissues was more effective and comparably safe to a 10-s RF algorithm using more superficial ablations.

Two-year real-world results of lumbar discectomy with bone-anchored annular closure in patients at high risk of reherniation.

PURPOSE: To determine the safety and effectiveness of limited lumbar discectomy with additional implantation of an annular closure device (ACD) among patients at high risk of herniation recurrence treated in routine clinical practice. METHODS: This was a prospective, single-center study of lumbar discectomy for sciatica caused by intervertebral disc herniation with adjunctive ACD implantation to reduce herniation recurrence risk among high-risk patients with large annular defects. Patients returned for follow-up visits at 6 weeks, 12 weeks, 26 weeks, 1 year, and 2 years. Main outcomes included reoperation, herniation recurrence, back pain severity, leg pain severity, and Oswestry Disability Index (ODI). The minimum important difference was defined as ≥ 20 mm decrease relative to baseline for leg pain severity, ≥ 20 mm decrease for back pain severity, and ≥ 15-point decrease for ODI. RESULTS: Among 75 high-risk patients (mean age 45 years, 59% female), the cumulative event incidence through 2 years was 4.0% for reoperation and 1.4% for herniation recurrence. Mean leg pain severity decreased from 73 to 6 (p < 0.001), back pain severity decreased from 51 to 13 (p < 0.001), and ODI decreased from 49 to 7 (p < 0.001). The percentage of patients achieving the minimum important difference was 91% for leg pain, 65% for back pain, and 94% for ODI. CONCLUSION: In patients at high risk of herniation recurrence following limited lumbar discectomy in routine clinical practice, additional implantation of an ACD was safe and reherniation recurrence rates were low at 2-year follow-up, which is favorably compared to reported rates in high-risk patients.

Three-year results from a randomized trial of lumbar discectomy with annulus fibrosus occlusion in patients at high risk for reherniation.

BACKGROUND: A larger defect in the annulus fibrosus following lumbar discectomy is a well-known risk factor for reherniation. Procedures intended to prevent reherniation by sealing or occluding the annular defect warrant study in high-risk patients. This study sought to determine 3-year results of lumbar discectomy with a bone-anchored annular closure device (ACD) or lumbar discectomy only (controls) in patients at high risk for reherniation. METHODS: This multicenter randomized trial enrolled patients with sciatica due to lumbar intervertebral disc herniation who failed conservative treatment. Patients with large annular defects after lumbar limited microdiscectomy were intraoperatively randomly assigned to receive ACD or control. Clinical and imaging follow-up was performed at routine intervals over 3 years. Main outcomes included rate of reherniations, reoperations, and endplate changes; leg and back pain scores on a visual analogue scale; Oswestry Disability Index (ODI); Physical Component Summary (PCS) and Mental Component Summary (MCS) scores from the SF-36; and adverse events adjudicated by a data safety monitoring board. RESULTS: Among 554 randomized patients, the modified intent-to-treat population consisted of 272 patients in which ACD implantation was attempted and 278 receiving control; device implantation was not attempted in 4 patients assigned to ACD. Outcomes at 3 years favored ACD for symptomatic reherniation (14.8% vs. 29.5%; P < 0.001), reoperation (11.0% vs. 19.3%; P = 0.007), leg pain (21 vs. 30; P < 0.01), back pain (23 vs. 30; P = 0.01), ODI (18 vs. 23; P = 0.02), PCS (47 vs. 44; P < 0.01), and MCS (52 vs. 49; P < 0.01). The frequency of all-cause serious adverse events was comparable between groups (42.3% vs. 44.5%; P = 0.61). CONCLUSIONS: The addition of a bone-anchored ACD in patients with large annular defects following lumbar discectomy reduces the risk of reherniation and reoperation, and has a similar safety profile over 3-year follow-up compared with lumbar limited discectomy only. TRIAL REGISTRATION: ClinicalTrials.gov NCT01283438.

Cost Analysis of Dual-Mobility Versus Large Femoral Head Constructs in Revision Total Hip Arthroplasty.

BACKGROUND: The purpose of this study is to report healthcare payer costs of dual-mobility (DM) and large femoral head (LFH) constructs in revision total hip arthroplasties (THAs). METHODS: A Markov model was constructed to analyze costs of re-interventions incurred by Medicare and private payers over a 3-year time horizon in patients who underwent unilateral revision THA with DM (n = 126) or LFH (n = 176) implants. Model states and probabilities were derived from prospectively collected registry data. Medicare costs were estimated as the weighted-average national Medicare payment for revision THA. Private payer costs were estimated by using a multiplier of Medicare costs. RESULTS: Over a 3-year period following revision THA, re-interventions were performed in 11 (9%) DM patients and 34 (19%) LFH patients, costing $263-$1898 in DM THAs and $1285-$3946 in LFH THAs for Medicare. When compared to LFH implants, DM constructs were less costly to Medicare and private payers, resulting in cost differentials of $1536 and $2611, respectively. CONCLUSIONS: At mid-term follow-up, DM constructs utilized in revision THAs were associated with 11% lower absolute risk of re-intervention and payer savings of $1500-$2500 per case when compared to LFH constructs. LEVEL OF EVIDENCE: Economic and decision analysis, Level III.

A Food-Derived Dietary Supplement Containing a Low Dose of Iron Improved Markers of Iron Status Among Nonanemic Iron-Deficient Women.

OBJECTIVE: Iron deficiency is the most common nutrient deficiency in the world. While deficiency can often be resolved through dietary supplementation with iron, adverse events are common and frequently preclude compliance. The objective of this study was to determine whether a food-derived dietary supplement containing a low dose of iron and nutrients that increase iron absorption could resolve iron deficiency with fewer adverse events than reported at higher doses. METHODS: A pilot clinical trial (NCT02683369) was conducted among premenopausal women with nonanemic iron deficiency that was verified by blood screening. Participants consumed a dietary supplement (Blood Builder®/Iron Response®) once daily for 8 weeks containing 26 mg of iron, vitamin C, folate, and other food-derived nutrients. Primary outcomes were markers of iron status (serum ferritin, hemoglobin, soluble transferrin receptor, total body iron stores) and secondary outcomes were self-reported fatigue and energy. All outcomes were assessed at baseline and 8 weeks. Adverse events were monitored with questionnaires, daily diaries, and contact with a physician. Dependent samples t test and Wilcoxon signed-rank test were used to analyze outcomes. RESULTS: Twenty-three participants enrolled in the study. Iron deficiency was resolved in the sample (mean serum ferritin: baseline = 13.9 µg/L, 8 weeks = 21.1 µg/L, p < 0.001). All other markers of iron status, fatigue, and energy also improved during the study (p < 0.04). No adverse events were reported. CONCLUSIONS: While larger and controlled studies are needed to confirm these findings, a food-derived dietary supplement with a low dose of iron and absorption-enhancing nutrients resolved iron deficiency and improved all other markers of iron status without any adverse events.

Perioperative Outcomes From the Prospective Multicenter Least Invasive Fast-Track EVAR (LIFE) Registry.

PURPOSE: To determine the feasibility, perioperative resource utilization, and safety of a fast-track endovascular aneurysm repair (EVAR) protocol in well-selected patients. METHODS: Between October 2014 and May 2016, the LIFE (Least Invasive Fast-track EVAR) registry ( ClinicalTrials.gov identifier NCT02224794) enrolled 250 patients (mean age 73±8 years; 208 men) in a fast-track EVAR protocol comprised of bilateral percutaneous access using the 14-F Ovation stent-graft, no general anesthesia, no intensive care unit (ICU) admission, and next-day discharge. The primary endpoint was major adverse events (MAE) through 30 days. The target performance goal for the MAE endpoint was 10.4%. RESULTS: Vascular access, stent-graft delivery, and stent-graft deployment success were 100%. A total of 216 (86%) patients completed all elements of the fast-track EVAR protocol. Completion of individual elements was 98% for general anesthesia avoidance, 97% for bilateral percutaneous access, 96% for ICU avoidance, and 92% for next-day discharge. Perioperative outcomes included mean procedure time of 88 minutes, median blood loss of 50 mL, early oral nutrition (median 6 hours), early mobilization (median 8 hours), and short hospitalization (median 26 hours). Fast-track EVAR completers had shorter procedure time (p<0.001), less blood loss (p=0.04), faster return to oral nutrition (p<0.001) and ambulation (p<0.01), and shorter hospital stay (p<0.001). With 241 (96%) of the 250 patients returning for the 30-day follow-up, the MAE incidence was 0.4% (90% CI 0.1% to 1.8%), significantly less than the 10.4% performance goal (p<0.001). No aneurysm rupture, conversion to surgery, or aneurysm-related secondary procedure was reported. There were no type III endoleaks and 1 (0.4%) type I endoleak. Iliac limb occlusion was identified in 2 (0.8%) patients. The 30-day hospital readmission rate was 1.6% overall. CONCLUSION: A fast-track EVAR protocol was feasible in well-selected patients and resulted in efficient perioperative resource utilization with excellent safety and effectiveness.

Early Outcomes with Fast-Track EVAR in Teaching and Nonteaching Hospitals.

BACKGROUND: The influence of hospital teaching status on fast-track endovascular aneurysm repair (EVAR) outcomes is unknown. This study explored the feasibility, safety, and effectiveness of a fast-track EVAR protocol at teaching and nonteaching hospitals. METHODS: Patients underwent a fast-track EVAR protocol composed of bilateral percutaneous access using a 14F stent graft, avoidance of general anesthesia and intensive care admission, and next-day discharge. Patients were followed up for 1 month post-treatment. Participating hospitals were categorized by teaching status (teaching versus nonteaching) and compared for perioperative and 30-day outcomes. RESULTS: Between October 2014 and May 2016, 250 patients were enrolled at 31 centers in the United States. The study included 186 patients treated among 21 teaching hospitals and 64 patients treated among 10 nonteaching hospitals. Fast-track EVAR protocol completion was higher at teaching hospitals (91% vs. 73%, P = 0.01). Intensive care admission was avoided in 99% of patients at teaching hospitals versus 84% at nonteaching hospitals (P < 0.001). The ability to complete all other fast-track EVAR elements was proportionally higher at teaching hospitals, but differences were not statistically different. In-hospital outcomes by teaching status were comparable overall. Median time to discharge was 25 and 26 hr, respectively. There were no reports of type III endoleak, abdominal aortic aneurysm rupture, or secondary intervention. Comparing teaching versus nonteaching hospitals, there were no differences in major adverse events (1% vs. 0%), type I endoleak (0% vs. 2%), limb occlusion (1% vs. 0%), all-cause mortality (1% vs. 0%), and 30-day readmissions (1% vs. 3%). CONCLUSIONS: A fast-track EVAR protocol can be implemented with high success in well-selected patients at teaching and nonteaching hospitals. Health care resource utilization, perioperative data, and 30-day outcomes were excellent overall, with higher frequency of intensive care admission at nonteaching hospitals.

Does Surgical Approach Affect Outcomes in Total Hip Arthroplasty Through 90 Days of Follow-Up? A Systematic Review With Meta-Analysis.

BACKGROUND: The choice between anterior approach (AA) and posterior approach (PA) in primary total hip arthroplasty (THA) is controversial. Previous reviews have predominantly relied on data from retrospective studies. METHODS: This systematic review included prospective studies comparing postoperative outcomes through 90 days of AA vs PA in primary THA. Outcomes were pain severity, narcotic usage, hip function using Harris Hip Score, and complications. Random effects meta-analysis was performed for all outcomes. Efficacy data were reported as standardized mean difference (SMD) where values of 0.2, 0.5, 0.8, and 1.0 were defined as small, medium, large, and very large effect sizes, respectively. Complications were reported as the absolute risk difference (RD) where a positive value implied higher risk with AA and a lower value implied lower risk with AA. RESULTS: A total of 13 prospective comparative studies (7 randomized) with patients treated with AA (n = 524) or PA (n = 520) were included. The AA was associated with lower pain severity (SMD = -0.37, P < .001), lower narcotic usage (SMD = -0.36, P = .002), and improved hip function (SMD = 0.31, P = .002) compared to PA. No differences between surgical approaches were observed for dislocation (RD = 0.2%, P = .87), fracture (RD = 0.2%, P = .87), hematoma (RD = 0%, P = .99), infection (RD = 0.2%, P = .85), thromboembolic event (RD = -0.9%, P = .42), or reoperation (RD = 1.3%, P = .26). Conclusions of this study were unchanged when subjected to sensitivity analyses. CONCLUSION: In this systematic review and meta-analysis of prospective studies comparing postoperative outcomes through 90 days of AA vs PA in primary THA, patients treated with AA reported less pain, consumed fewer narcotics, and reported better hip function. No statistical differences in complication rates were detected between AA and PA. Ultimately, the choice of surgical approach in primary THA should consider preference and experience of the surgeon as well as preference and anatomy of the patient.

Influence of surgical approach on complication risk in primary total hip arthroplasty.

Background and purpose - Systematic comparisons of anterior approach (A) versus posterior approach (P) in primary total hip arthroplasty (THA) have largely focused on perioperative outcomes. In this systematic review with meta-analysis, we compared complication risk of A versus P in studies of primary THA with at least 1-year mean follow-up. Patients and methods - We performed a systematic review of prospective and retrospective studies with at least 1-year mean follow-up that reported complications of A and P primary THA. Complications included infection, dislocation, reoperation, thromboembolic event, heterotopic ossification, wound complication, fracture, and nerve injury. Random effects meta-analysis was used for all outcomes. Complication risk was reported as rate ratio (RR) to account for differential follow-up durations; values >1 indicated higher complication risk with A and values <1 indicated lower risk with A. Results - 19 studies were included; 15 single-center comparative studies with 6,620 patients (2,278 A; 4,342 P) and 4 multicenter registries with 157,687 patients (18,735 A; 138,952 P). Median follow-up was 16 (12-64) months) with A and 18 (12-110) months with P. Anterior approach was associated with lower rate of infection (RR =0.55, p = 0.002), dislocation (RR =0.65, p = 0.03), and reoperation (RR =0.84, p < 0.001). No statistically significant differences were observed in rate of thromboembolic event (RR =0.59, p = 0.5), heterotopic ossification (RR =0.63, p = 0.1), wound complication (RR =0.93, p = 0.8), or fracture (RR =1.0, p = 0.9). There was a higher rate of patient-reported nerve injury with A (RR =2.3, p = 0.01). Interpretation - Comparing A with P in primary THA, A was associated with lower risk of reoperation, dislocation, and infection, but higher risk of patient-reported nerve injury.

A Propensity Score-Matched Analysis of Inflammatory Response With Endovascular Aneurysm Sealing vs Endovascular Aneurysm Repair.

PURPOSE: To evaluate the risk of postimplantation syndrome associated with endovascular aneurysm sealing (EVAS) and endovascular aneurysm repair (EVAR) in patients treated for abdominal aortic aneurysm (AAA). METHODS: From December 2013 to May 2015, 41 AAA patients treated with EVAS (mean age 72±9 years; 38 men) and 63 with EVAR (mean age 74±10 years; 55 men) at a single center were retrospectively reviewed. To control for treatment selection bias, propensity score matching was used to compare outcomes by treatment mode. Main outcomes were postimplantation syndrome (defined as temperature >38°C and leukocyte count >12,000/µL), inflammatory response markers [platelets and high-sensitivity C-reactive protein (hs-CRP)], and clinical complications through 30 days. RESULTS: In 39 matched patients per group, the incidences of postimplantation syndrome (p=0.07), mean body temperature (p=0.05), mean leukocyte count (p=0.003), and mean hs-CRP (p<0.001) were proportionally lower with EVAS vs EVAR. Serious adverse events (0% vs 12.8%, p=0.05) and endoleaks (0% vs 10.3%, p=0.13) through 30 days were less frequent with EVAS, but the group differences were not significantly different. The choice of endovascular graft material influenced postoperative and 30-day clinical outcomes, with greater overall risk observed with polyester stent-grafts. CONCLUSION: Endovascular aneurysm sealing is associated with a blunted systematic inflammatory response compared with EVAR. Polyester stent-grafts induce the greatest periprocedural inflammatory response.

Persistent right ventricular dysfunction, functional capacity limitation, exercise intolerance, and quality of life impairment following pulmonary embolism: Systematic review with meta-analysis.

Long-term right ventricular (RV) function, functional capacity, exercise capacity, and quality of life following pulmonary embolism (PE), and the impact of thrombolysis, are unclear. A systematic review of studies that evaluated these outcomes with ⩾ 3-month mean follow-up after PE diagnosis was performed. For each outcome, random effects meta-analyses were performed. Twenty-six studies (3671 patients) with 18-month median follow-up were included. The pooled prevalence of RV dysfunction was 18.1%. Patients treated with thrombolysis had a lower, but not statistically significant, risk of RV dysfunction versus those treated with anticoagulation (odds ratio: 0.51, 95% CI: 0.24 to 1.13, p=0.10). Pooled prevalence of at least mild functional impairment (NYHA II-IV) was 33.2%, and at least moderate functional impairment (NYHA III-IV) was 11.3%. Patients treated with thrombolysis had a lower, but not statistically significant, risk of at least moderate functional impairment versus those treated with anticoagulation (odds ratio: 0.48, 95% CI: 0.15 to 1.49, p=0.20). Pooled 6-minute walk distance was 415 m (95% CI: 372 to 458 m), SF-36 Physical Component Score was 44.8 (95% CI: 43 to 46), and Pulmonary Embolism Quality of Life (QoL) Questionnaire total score was 9.1. Main limitations included heterogeneity among studies for many outcomes, variation in the completeness of data reported, and inclusion of data from non-randomized, non-controlled, and retrospective studies. Persistent RV dysfunction, impaired functional status, diminished exercise capacity, and reduced QoL are common in PE survivors. The effect of thrombolysis on RV function and functional status remains unclear.

Multimodal vaginal toning for bladder symptoms and quality of life in stress urinary incontinence.

INTRODUCTION AND HYPOTHESIS: Treatment options for women with stress urinary incontinence (SUI) have limitations. We hypothesized that multimodal vaginal toning therapy would improve bladder symptoms and quality of life in women with postpartum SUI and sexual function complaints. METHODS: Patients self-administered 24 sessions of multimodal vaginal toning therapy lasting 10 min each over 50 days. Outcomes included 1-h pad weight test, Urogenital Distress Inventory Short Form (UDI-6), Incontinence Impact Questionnaire-Short Form (IIQ-7), Female Sexual Distress Scale-Revised 2005 (FSDS-R), Female Sexual Function Index (FSFI), pelvic floor muscle strength, patient satisfaction, and adverse events. RESULTS: Of the 55 patients enrolled (safety population), 48 completed the study per-protocol (PP population). A total of 38 (79%) patients had a positive 1-h pad weight test at baseline. In this group, urine leakage was moderate or severe in 82% of patients at baseline, but in only 18% after treatment. Treatment success was 84%, defined as >50% improvement in pad weight relative to baseline. In the PP population, mean UDI-6 score improved by 50% (p < 0.001) and IIQ-7 score improved by 69% (p < 0.001). Sexual function quality of life improved by 54% for FSDS-R and 15% for FSFI (both p < 0.001). Pelvic floor muscle strength significantly improved (p < 0.001). Patient satisfaction with therapy was reported in 83% of patients. In the safety population, 2 (3.6%) adverse events were reported-1 urinary tract infection and 1 report of discomfort due to excessive warmth. CONCLUSIONS: Multimodal vaginal toning therapy yields clinically meaningful improvements in bladder symptoms, pelvic floor muscle strength, and quality of life in women with SUI.

Biocomposite Implants Composed of Poly(Lactide-co-Glycolide)/ß-Tricalcium Phosphate: Systematic Review of Imaging, Complication, and Performance Outcomes.

PURPOSE: To determine the degradation and performance outcomes of poly(lactide-co-glycolide)/ß-tricalcium phosphate (PLGA/ß-TCP) implants. METHODS: A MEDLINE and Embase search for randomized or nonrandomized controlled studies and prospective or retrospective case series that used biocomposite interference screws or suture anchors composed of PLGA/ß-TCP was performed. Main outcomes included volume of implant resorption and incidence of osteoconductivity at implant sites, imaging findings, adverse events, and the frequency of reoperations. RESULTS: A total of 13 studies representing 668 patients with either knee or shoulder implants were included. Median follow-up was 28 months (range: 12-37 months). Biocomposite implants lost 88% of their original volume during follow-up. Osteoconductivity at the implant site was identified in 63% of cases. Adverse events included tunnel widening (3%), effusion (5%), and cyst formation (4%). Synovitis was not reported. CONCLUSIONS: Biocomposite interference screws or suture anchors composed of PLGA/ß-TCP almost fully absorb over 3 years while promoting osteoconductivity with few reported adverse events. LEVEL OF EVIDENCE: Level IV, systematic review of Level I-IV studies.

Fast-track endovascular aortic repair: Interim report from the prospective LIFE registry.

OBJECTIVE: To assess the feasibility, safety, and clinical utility of a fast-track endovascular aneurysm repair (EVAR) protocol. BACKGROUND: Despite recent advances in EVAR technology and techniques, considerable opportunity exists to further improve EVAR efficiency and outcomes. METHODS: Eligible patients underwent elective EVAR with the Ovation Prime stent graft. Successful completion of the fast-track protocol required bilateral percutaneous access, avoidance of general anesthesia and intensive care unit admission, and next-day discharge. Patients were followed through 1-month post-treatment. RESULTS: Between October 2014 and September 2015, 129 patients were enrolled in the study. Vascular access, stent graft delivery, and stent graft deployment were successful in all patients. The fast-track EVAR protocol was successfully completed in 114 (88%) patients. Bilateral percutaneous access was achieved in 97% of cases. Comparing patients who completed fast-track requirements to those who failed at least one component, procedure time was 86 vs. 122 min, use of general anesthesia was 0% vs. 20%, need for intensive care unit stay was 0% vs. 13%, hospital stay was 1.1 vs. 2.1 days, and postoperative groin pain severity (0-10 scale) was 1.2 vs. 4.0. No type I or III endoleaks, serious device-related adverse events, AAA ruptures, surgical conversions, or AAA-related secondary procedures were reported. One (0.9%) patient in the fast-track group died from acute respiratory failure. CONCLUSIONS: Initial results from the LIFE study are encouraging and suggest that a fast-track protocol is feasible, safe, and may improve efficiency of healthcare resource allocation in select patients undergoing EVAR. © 2016 Wiley Periodicals, Inc.