Feasibility and preliminary clinical tolerability of low-field MRI-guided prostate biopsy.

OBJECTIVE: We evaluate the clinical feasibility of a portable, low-field magnetic resonance imaging (MRI) system for prostate cancer (PCa) biopsy. METHODS: A retrospective analysis of men who underwent a 12-core systematic transrectal ultrasound-guided prostate biopsy (SB) and a low-field MRI guided transperineal targeted biopsy (MRI-TB). Comparison of the detection of clinically significant PCa (csPCa) (Gleason Grade [GG] ≥ 2) by SB and low field MRI-TB, stratified by Prostate Imaging Reporting & Data System (PI-RADS) score, prostate volume, and prostate serum antigen (PSA) was performed. RESULTS: A total of 39 men underwent both the MRI-TB and SB biopsy. Median (interquartile range [IQR]) age was 69.0 (61.5-73) years, body mass index (BMI) was 28.9 kg/m2 (25.3-34.3), prostate volume was 46.5 cc (32-72.7), and PSA was 9.5 ng/ml (5.5-13.2). The majority (64.4%) of patients had PI-RADS ≥ 4 lesions and 25% of lesions were anterior on pre-biopsy MRII. Cancer detection rate (CDR) was greatest when combining SB and MRI-TB (64.1%). MRI-TB detected 74.3% (29/39) cancers. Of which, 53.8% (21/39) were csPCa while SB detected 42.5% (17/39) csPCa (p = 0.21). In 32.5% (13/39) of cases, MRI-TB upstaged the final diagnosis, compared to 15% (6/39) of cases in which SB upstaged the final diagnosis (p = 0.11). CONCLUSION: Low-field MRI-TB is clinically feasible. Although future studies on the accuracy of MRI-TB system are needed, the initial CDR is comparable to those seen with fusion-based prostate biopsies. A transperineal and targeted approach may be beneficial in patients with higher BMI and anterior lesions.

Characterization of the histological response to the Butterfly Prostatic Retraction Device in patients with benign prostatic hyperplasia.

PURPOSE: The Butterfly Prostatic Retraction Device ("Butterfly") is a permanent nitinol implant for benign prostatic hyperplasia. This study examines the chronic response of prostate tissue to the Butterfly in histological specimens from patients in the Butterfly pilot clinical study. METHODS: Retrospective qualitative and semi-quantitative review of histological specimens of seven (7) patients who participated in the Butterfly pilot clinical study. Patients had at least 1-month implantation with the Butterfly prior to implant removal and TURP. Tissue samples were graded by two pathologists. RESULTS: Four out of six patients had IPSS decreased from baseline. All seven patients' samples had signs of chronic inflammation; one demonstrated acute inflammation and one demonstrated fibrosis. In three cases, intraglandular calcification was identified. There was no ischemic necrosis induced by the implant, and no encrustation, urethral edema, or cellular atypia was noted. CONCLUSION: The Butterfly demonstrated an overall favorable safety profile in terms of tissue response. This study demonstrates that there is no significant tissue reaction in the prostatic urethra due to presence of Butterfly device.

How Does Gravity Influence the Distribution of Lordosis in Patients With Sagittal Malalignment?

STUDY DESIGN: Retrospective cohort study. OBJECTIVE: Compare the supine vs standing radiographs of patients with adult spinal deformity against ideals defined by healthy standing alignment. METHODS: 56 patients with primary sagittal ASD (SRS-Schwab Type N) and 119 asymptomatic volunteers were included. Standing alignment of asymptomatic volunteers was used to calculate PI-based formulas for normative age-adjusted standing PI-LL, L4-S1, and L1-L4. These formulas were applied to the supine and standing alignment of ASD cohort. Analyses were repeated on a cohort of 25 patients with at least 5 degrees of lumbar flexibility (difference between supine and standing lordosis). RESULTS: The asymptomatic cohort yielded the following PI-based formulas: PI-LL = -38.3 + .41*PI + .21*Age, L4-S1 = 45.3-.18*Age, L1-L4 = -3 + .48*PI). PI-LL improved with supine positioning (mean 8.9 ± 18.7°, P < .001), though not enough to correct to age-matched norms (mean offset 12.2 ± 16.9°). Compared with mean normative alignment at L1-L4 (22.1 ± 6.2°), L1-L4 was flatter on standing (7.2 ± 17.0°, P < .001) and supine imaging (8.5 ± 15.0°, P < .001). L4-S1 lordosis of subjects with L1-S1 flexibility >5° corrected on supine imaging (33.9 ± 11.1°, P = 1.000), but L1-L4 did not (23.0 ± 6.2° norm vs 2.2 ± 14.4° standing, P < .001; vs 7.3 ± 12.9° supine, P < .001). CONCLUSIONS: When the effects of gravity are removed, the distal portion of the lumbar spine (i.e., below the apex of lordosis) corrects, suggesting that structural lumbar deformity is primarily proximal.

Timing of inpatient medical complications after adult spinal deformity surgery: early ambulation matters.

BACKGROUND: The substantial risk for medical complication after adult spinal deformity (ASD) surgery is well known. However, the timing of medical complications during the inpatient stay have not been previously described. Accurate anticipation of complications and adverse events may improve patient counseling and postoperative management. PURPOSE: (1) Describe the rate of medical complication and adverse events by postoperative day after ASD surgery and (2) determine whether early ambulation is protective for complications. STUDY DESIGN/SETTING: Single institution retrospective cohort study. PATIENT SAMPLE: Two hundred thirty-five patients with ASD who underwent posterior-only fusion of the lumbar spine (≥5 levels to the pelvis) between 2013 and 2020. OUTCOME MEASURES: Medical complications, categorized per the International Spine Study Group-AO system (cardiopulmonary [CP], gastrointestinal [GI], central nervous system [CNS], infectious [nonsurgical site], and renal) and adverse events (postoperative blood transfusion, urinary retention, and electrolyte abnormalities). METHODS: Patients were identified from an institutional ASD database. Outcome measures were classified by the first postoperative day the event was recognized. Demographics, year of surgery, surgical factors, radiographic parameters, surgical invasiveness (ASD-S Index), frailty (Modified Frailty Index-5 [mFI-5]), Charlson Comorbidity Index (CCI), obstructive sleep apnea (OSA), smoking, preoperative opioid use, depression, and post-operative day of ambulation were assessed as risk factors for inpatient medical complications. RESULTS: After exclusions of patients with incomplete medical chart data, 191 patients were available for analysis, mean age 66±10 y, BMI 28±5 kg/m2, PI-LL 24±20°, T1PA 28±13°. Inpatient medical complications occurred in 55 (28.8%) patients; adverse events occurred in 137 (71.7%). Length of stay was higher in patients with medical complications (mean 8.5±3.8 vs. 5.8±2.3 days, p<.001). However, for patients who had an adverse event, but no medical complication, LOS was comparable (p>.05). Most medical complications occurred by POD3 (58% of all complications). Risk (defined as the proportion of patients with that complication out of all inpatients that day) of CNS, CP, and GI complication peaked early in the postoperative course (CNS on POD1 [2.1% risk]; GI on POD2 [3.7%]; CP on POD3 [2.7%]). Risk for infectious and renal complications (infectious POD8 [2.7%]; renal POD7 [0.9%]) peaked later (Figure 1). On univariate analysis, patients with medical complications had higher rates of OSA (9.1% vs. 2.2%, p=.045), ASD-S (45.9 vs. 40.8, p=.04), max coronal cobb (46.9 vs. 36.7°, p=.003), ASA class (2.5 vs. 2.3, p=.01), and POD of ambulation (1.9 vs. 1.3, p=.01). On multivariate logistic regression (c-statistic 0.78), larger coronal cobb and later POD of ambulation were independent risk factors for complications (OR 1.04, 95% CI 1.01-1.07 and OR 2.3, 95% CI 1.2-4.7, respectively). CONCLUSIONS: Our data may inform peri-operative management and patient expectations for hospitalization after ASD surgery. Early ambulation may reduce the risk of complications.

Can Discharge Radiographs Predict Junctional Complications? A Decision Tree Analysis.

STUDY DESIGN: Retrospective cohort study. OBJECTIVES: To determine if standing pre-discharge radiographs can predict the development of junctional complications. MATERIALS AND METHODS: Adult spinal deformity patients who underwent fusion of the lumbar spine (≥5 levels, LIV pelvis) were included. All patients underwent full-length standing radiographs before hospital discharge. Outcomes of interest included 2-year radiographic PJK and proximal junctional failure (PJF). Patients were stratified into 3 exclusive groups: No PJK, PJK, and PJF. Chi-square automatic interaction detection (CHAID) decision tree analysis was utilized to identify pre-discharge proximal junctional angle (PJA) thresholds associated with increased risk of PJK or PJF. RESULTS: The 117 study patients had a mean age 65.8 ± 8.5, BMI 27.2 ± 4.9, PI-LL 23.3 ± 17.4, TPA 27.2 ± 11.5. Sample was stratified into 64 (54.7%) No PJK, 39 (33.3%) PJK, 14 (12.0%) PJF. No differences were detected between cohorts in discharge alignment, preop-discharge change, or offset from age-adjusted alignment targets (P > .005). Decision tree analysis showed that the first branch point depended on the UIV, as most patients with an UT UIV did not develop PJK or PJF (no PJK, 67.4%). For patients with an LT UIV, a second branch point occurred based on the ΔPJA. 89.5% of LT patients with a ΔPJA < 4.3° were free of radiographic PJK and PJF. The third branch point occurred based on the PJA at discharge. Thus, the highest risk group was comprised of ΔPJA ≥4.3° and PJA > 15.5°, as 57.1% of developed PJF and 28.6% PJK. CONCLUSION: Most patients with a lower thoracic UIV, preop-discharge ΔPJA ≥4.3°, and discharge PJA > 15.5° develop PJF.

Shoulder Balance in Adult Spinal Deformity Patients Undergoing Selective Lumbar Fusion.

STUDY DESIGN: Retrospective review. OBJECTIVE: To analyze if shoulder balance continues to change in the postoperative period in patients undergoing selective lumbar fusion for adult spinal deformity (ASD), and secondarily, analyze if shoulder balance correlates with health-related quality of life (HRQOL) outcomes. SUMMARY OF BACKGROUND DATA: Shoulder balance in patients with ASD is poorly understood and has largely been extrapolated from adolescent scoliosis literature. MATERIALS AND METHODS: Adult patients who underwent selective lumbar fusion (upper instrumented vertebra: Τ9-Τ12, lower instrumented vertebra: L4-Pelvis) for thoracolumbar or lumbar scoliosis (cobb angle > 30°) or sagittal plane deformity with thoracic compensatory curves (cobb angle > 10°) were identified. The clavicular angle (CA) was used to quantify shoulder balance. Shoulder balance was categorized into three groups postoperatively (balanced: CA <2°, mild imbalance: CA 2°-4°, severe imbalance: CA >4°). The average CA and proportion of patients in each shoulder balance group were compared at each postoperative period. Patients with 1-year postoperative HRQOL scores were identified. RESULTS: Eighty-six patients were included. The preoperative CA was 2.7 ±â€Š2.3° and did not significantly change at discharge (2.9 ±â€Š2.4°), 6-weeks (2.5 ±â€Š2.1°), 6-months (2.4 ±â€Š2.2°), 1-year (2.4 ±â€Š2.5°), or 2-years (2.3 ±â€Š1.5°) postoperatively. The proportion of patients in each shoulder balance group did not significantly change from discharge to 6-weeks, 6-months, 1-year or 2-years postoperatively (P > 0.1). At 1-year follow-up, the CA demonstrated no significant correlation with Oswestry Disability Index, Scoliosis Research Society (SRS)-22 score, or SRS-22 subscores. There was no significant association between shoulder balance group and Oswestry Disability Index, SRS-22 score, or SRS-22 subscores. CONCLUSIONS: In patients with ASD undergoing selective lumbar fusion, shoulder balance did not change over the postoperative period. From a functional standpoint, shoulder balance demonstrated no correlation with HRQOL scores. In patients undergoing selective lumbar fusion for ASD, shoulder balance may not spontaneously correct over the postoperative period, but this may not be of functional consequence.Level of Evidence: 4.

Review of the Economics of Surgical Treatment Options for Benign Prostatic Hyperplasia.

PURPOSE OF REVIEW: The goal of this paper is to review the literature detailing US-based analyses for cost and cost-effectiveness of surgical treatment options for benign prostatic hypertrophy (BPH) and associated LUTS. RECENT FINDINGS: TURP offers the greatest degree of symptom improvement with its associated costs dependent upon operating room time, equipment, and length of hospital stay. Other studied surgical treatment modalities, including transurethral laser ablative, thermal ablative, and convective water vapor modalities as well as prostatic urethral lift and transabdominal procedures, generally carry higher costs and lower cost-effectiveness in both inpatient and outpatient settings, with specific exceptions. Compared to TURP, HoLEP and Greenlight PVP have demonstrated superior cost-effectiveness for mild, moderate, and severe BPH. Convective water vapor ablation, as with transurethral microwave/thermoablative therapies, has been observed to be less expensive per procedure than TURP on average. However, it conferred lower degrees of IPSS symptom improvement. Moreover, compared to TURP, prostatic artery embolization has demonstrated lower average costs coupled with inferior objective improvement in maximal flow rate, prostate volume reduction, PSA decline and minimal improvement in IPSS subjective outcome measures. For this review, selection bias, asymmetric patient groups, issues with study aggregation, and understudied cost contributors (including retreatment costs, long-term durability of symptom relief, recovery time, and work productivity limitations) were identified as key limitations. Nevertheless, this overview takes important steps to understand the costs of surgical treatment options for BPH, allowing for more informed clinical and policy decisions.

Characterization of a Novel Implant Intended to Expand and Reshape the Prostatic Urethra for the Treatment of Benign Prostatic Hyperplasia: A Pre-Clinical Feasibility Study in the Canine Model.

OBJECTIVE: To evaluate the safety, feasibility, and tissue response of a novel device for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia, using the first-generation Urocross Expander System (Mercury Expander System). METHODS: The implant was deployed and retrieved using flexible cystoscope in 8 adult male canines, separated into three study arms by retrieval date (1-, 6-, and 12- months post-deployment). Cystoscopy and urethrograms verified implant position/diameter; bladder neck and external sphincter function/changes; prostatic tissue response; and implant condition. One-month post-retrieval, the prostate and surrounding tissue was sectioned and evaluated by a veterinary pathologist. RESULTS: All implants were successfully deployed in the prostatic urethra. Urethral width was increased (6.9 ± 1.8 mm to 10.2 ± 0.6 mm, P = .012) and preserved through the dwell period. Urethral length and sphincter diameters didn't significantly change. All subjects (n = 8) remained continent without obstruction or retention. Adverse events included incisional site bleeding (n = 2) and transient hematuria (n = 3). One implant migrated into the bladder and spontaneously repositioned into the prostatic urethra. Post-retrieval, explant surfaces demonstrated no tissue growth, encrustation or stone formation. Imaging revealed contact site erythema and indentation, but no stones, strictures, perforations, erosions, nor ulcerations. Histopathology revealed glandular acinar changes, inflammation, and fibrosis. CONCLUSION: The first generation of the Urocross Expander System demonstrated a favorable safety profile in the canine model. Changes in the prostatic urethra shape were noted with an increase in urethral width during the dwell period with minimal tissue changes. Further, the implant didn't demonstrate any encrustation, tissue growth or stone formation.

Enhanced recovery pathway in adult patients undergoing thoracolumbar deformity surgery.

BACKGROUND CONTEXT: Enhanced recovery (ERAS) pathways can help hospitals maximize the incentives of bundled payment models while maintaining high-quality patient care. A key component of an enhanced recovery pathway is the ability to predictably reduce inpatient length of stay, as this is a critical component of the cost equation. PURPOSE: To determine the efficacy of an enhanced recovery pathway on reducing length of stay after thoracolumbar adult deformity surgery. STUDY DESIGN: Single surgeon retrospective review of prospectively-collected data. PATIENT SAMPLE: Forty adult deformity patients who underwent ≥5 levels of fusion to the pelvis (two to L5) with a single surgeon before and after implementation of an ERAS pathway. METHODS: The pathway involved participation by anesthesiology, hospital medicine, and physical therapy, and was designed to achieve goals previously associated with decreased LOS (eg, EBL<1200 mL, procedure time <4.5 hours, avoidance of ICU postoperatively, and mobilization POD0-1). Patients were propensity-score matched 1:1 to a historical cohort (enhanced recovery [ER] and historical [H] cohorts), based on demographics, medical comorbidities, radiographic alignment parameters, and surgical factors. Outcomes were compared to determine the effect of the enhanced recovery pathway. Primary outcomes included LOS and 90-day complications and readmissions. RESULTS: After matching, gender, BMI, ASA class, preoperative opioid dependence, day of surgery, sagittal alignment parameters, rate of revision surgery, three-column osteotomies, and interbody fusions were comparable between the cohorts (p>.05). In the ER cohort, there was reduced EBL (920±640 vs. 1437±555, p=.004) and no ER patient went to the ICU immediately following surgery, compared with 30% of H patients (p=.022). The ER cohort also had a greater number of patients ambulating by POD1 compared to the H cohort (100% vs. 55%, p=.010). ER patients had a shorter LOS (4.5±1.3 vs. 7.3±4.4 days, p=.010). A 90-day readmission and complications were comparable between the cohorts (p>.05). CONCLUSIONS: The creation of an ERAS pathway for patients undergoing thoracolumbar adult deformity surgery reduced length of stay without negatively affecting short-term morbidity and complications. Given the specificity of this pathway to a single surgeon and hospital, the resources and staffing changes that were instrumental in creating the pathway may not be generalizable to other centers.

Aggregation and analysis of indication-symptom relationships for drugs approved in the USA.

PURPOSE: Drug indications and disease symptoms often confound adverse event reports in real-world datasets, including electronic health records and reports in the FDA Adverse Event Reporting System (FAERS). A thorough, standardized set of indications and symptoms is needed to identify these confounders in such datasets for drug research and safety assessment. The aim of this study is to create a comprehensive list of drug-indication associations and disease-symptom associations using multiple resources, including existing databases and natural language processing. METHODS: Drug indications for drugs approved in the USA were extracted from two databases, RxNorm and Side Effect Resource (SIDER). Symptoms for these indications were extracted from MedlinePlus and using natural language processing from PubMed abstracts. RESULTS: A total of 1361 unique drugs, 1656 unique indications, and 2201 unique symptoms were extracted from a wide variety of MedDRA System Organ Classes. Text-mining precision was maximized at 0.65 by examining Term Frequency Inverse Document Frequency (TF-IDF) scores of the disease-symptom associations. CONCLUSION: The drug-indication associations and disease-symptom associations collected in this study may be useful in identifying confounders in other datasets, such as safety reports. With further refinement and additional drugs, indications, and symptoms, this dataset may become a quality resource for disease symptoms.

A model for an institutional response to the opioid crisis.

The use of opioid analgesics for pain management has increased dramatically over the past decade, with corresponding increases in negative sequelae including overdose and death. Physicians, policymakers, and researchers are focused on finding ways to decrease opioid use and overdose. This crisis calls for a coordinated response that includes the entire healthcare sector. In this work, the authors lay out a blueprint for such a response at the level of the academic medical center. The proposed model is a comprehensive opioid overdose prevention, response, and education program to evaluate, monitor, and address prescription opioid-related adverse events and addiction among all patients within a healthcare system. The approach includes three inter-related elements: (1) creation of an organizational structure that is subdivided into subcommittees to facilitate cross-functional collaboration and implementation. These subcommittees will focus on Research and Design, Implementation, Advisory, and Compliance with the recommendation. (2) Development of an effective communication plan throughout the institution to enable the organization to function seamlessly and efficiently as a single unit, (3) development of a data tracking and reporting system that intended to have a 360° view of all aspects of opioid prescription and downstream patient outcomes. The most effective response system will require an organizational structure that facilitates the ad hoc constitution of cross-functional teams with members drawn from all levels of the organizational hierarchy (executive leadership to frontline staff). Such a structure provides the teams with immediate solutions as developed by the frontline staff and authority to remove institutional barriers that may delay or limit the successful implementation. The model described was developed in our institution by a cross-functional team that included members from the Johns Hopkins School of Medicine and Johns Hopkins University Carey Business School, Department of Operations Management. The multidisciplinary nature of collaboration allowed us to develop a model for an immediate institution-wide response to the opioid crisis, and one that other healthcare organizations could adopt with local modification as a template for execution. The model also meant to serve as a template for an institutional rapid-response that can be seamlessly implemented during any future drug-related crisis or epidemic.