Citations

Background: The results of a recent pilot study suggest that steerable ureteroscopic renal evacuation (SURE) is safe and more effective in stone removal than basketing following laser lithotripsy. The objective of this retrospective study was to further assess the safety and efficacy of SURE using the CVAC ® Aspiration System (Calyxo, Inc., Pleasanton, CA) in patients with large stone burdens. Materials and Methods: Patients with a baseline stone burden of ≥10 mm who underwent SURE were identified. Subject demographics, secondary procedures, complications, and stone clearance (defined as percent baseline volume reduction) were evaluated. Subanalyses were performed to explore patients identified as high risk for percutaneous nephrolithotomy (PCNL) because (1) they were on anticoagulation or antiplatelet therapy at the time of procedure or (2) they had limited mobility due to neurologic conditions. Results: Identified patients ( N = 43) had a mean preoperative stone burden of 29 ± 12 mm and mean stone volume of 3092 ± 5002 mm 3 . Approximately one-half of patients ( n = 24, 55.8%) had CT imaging at follow-up, and of those, 8 (33.3%) had no residual stones, 22 (91.7%) had >90% stone clearance, 23 (95.8%) had >80% stone clearance, and 24 (100%) had >60% stone clearance. Stone clearance based on baseline stone burden varied between 93.8% and 98.9%. At baseline, 21 patients were anticipated to require staged ureteroscopy; however, only two of those (9.5%) needed secondary procedures. High-risk patients ( n = 22) were on anticoagulation or antiplatelet therapy ( n = 12) or had neurologic conditions ( n = 10). Stone clearance was 97% among patients in the anticoagulated cohort with postoperative CT imaging and 83% in the neurologic condition cohort. There were no device-related complications and no postoperative admissions. Conclusions: The CVAC Aspiration System is safe and effective for treating large stone burdens, including in high-risk patients, and may decrease the need for PCNL or secondary procedures. ClinicalTrials.gov Identifier: NCT04519294.

Abstract Background Although comorbidities are risk factors for recurrent Clostridioides difficile infection (rCDI), many clinical trials exclude patients with medical conditions such as malignancy or immunosuppression. In a phase 3, double-blind, placebo-controlled, randomized trial (ECOSPOR III), fecal microbiota spores, live (VOWST, Seres Therapeutics; hereafter “VOS,” formerly SER-109), an oral microbiota therapeutic, significantly reduced the risk of rCDI at week 8. We evaluated the efficacy of VOS compared with placebo in patients with comorbidities and other risk factors for rCDI. Methods Adults with rCDI were randomized to receive VOS or placebo (4 capsules daily for 3 days) following standard-of-care antibiotics. In this post hoc analysis, the rate of rCDI through week 8 was assessed in VOS-treated participants compared with placebo for subgroups including (i) Charlson comorbidity index (CCI) score category (0, 1–2, 3–4, ≥5); (ii) baseline creatinine clearance (<30, 30–50, >50 to 80, or >80 mL/minute); (iii) number of CDI episodes, inclusive of the qualifying episode (3 and ≥4); (iv) exposure to non-CDI-targeted antibiotics after dosing; and (v) acid-suppressing medication use at baseline. Results Of 281 participants screened, 182 were randomized (59.9% female; mean age, 65.5 years). Comorbidities were common with a mean overall baseline age-adjusted CCI score of 4.1 (4.1 in the VOS arm and 4.2 in the placebo arm). Across all subgroups analyzed, VOS-treated participants had a lower relative risk of recurrence compared with placebo. Conclusions In this post hoc analysis, VOS reduced the risk of rCDI compared with placebo, regardless of baseline characteristics, concomitant medications, or comorbidities.

Abstract Background Perianal fistulas and abscesses occur commonly as complications of pediatric Crohn’s disease (CD). A validated imaging assessment tool for quantification of perianal disease severity and activity is needed to evaluate treatment response. We aimed to identify magnetic resonance imaging (MRI)-based measures of perianal fistulizing disease activity and study design features appropriate for pediatric patients. Methods Seventy-nine statements relevant to MRI-based assessment of pediatric perianal fistulizing CD activity and clinical trial design were generated from literature review and expert opinion. Statement appropriateness was rated by a panel (N = 15) of gastroenterologists, radiologists, and surgeons using modified RAND/University of California Los Angeles appropriateness methodology. Results The modified Van Assche Index (mVAI) and the Magnetic Resonance Novel Index for Fistula Imaging in CD (MAGNIFI-CD) were considered appropriate instruments for use in pediatric perianal fistulizing disease clinical trials. Although there was concern regarding the use of intravascular contrast material in pediatric patients, its use in clinical trials was considered appropriate. A clinically evident fistula tract and radiologic disease defined as at least 1 fistula or abscess on pelvic MRI were considered appropriate trial inclusion criteria. A coprimary clinical and radiologic end point and inclusion of a patient-reported outcome were also considered appropriate. Conclusion Outcomes of treatment of perianal fistulizing disease in children must include MRI. Existing multi-item measures, specifically the mVAI and MAGNIFI-CD, can be adapted and used for children. Further research to assess the operating properties of the indices when used in a pediatric patient population is ongoing.

Objectives: The purpose of this study was to assess return to play (RTP), patient-reported outcomes (PRO), and reoperation rates following patellofemoral stabilization surgeries (PSS) for recurrent patellar instability (RPI) in a cohort of competitive wrestlers. Methods: All competitive wrestlers with a history of an RPI and subsequent PSS at a single institution between 2000 and 2020 were identified. Primary PSS ranged from MPFL reconstruction (n = 31; 50%) or MPFL repair (n = 22; 33.5%), and other PSS (n = 9; 14.5%) in the form of tibial tubercle osteotomy (TTO), lateral retinaculum release (LRR), and medial retinaculum reefing (MRR). Exclusion criteria included revision PSS, or concomitant anterior cruciate ligament reconstruction or multi ligament knee injury. All patients were contacted for determination of reinjury rates, current sport status, and PROs. Surgical failure defined as subsequent patellar dislocation despite operative management or need for secondary PSS. Results: Ultimately, 62 knees in 56 wrestlers were included at a mean follow-up time of 6.6 years (range, 2.0 – 18.8 years). RTP occurred in 55.3% of wrestlers at a mean of 8.8 ± 6.7 months. Among the PSS no differences were observed between rates of RTP (P = .676), postoperative pain (P = .176), Tegner activity level (P = .801), International Knee Documentation Committee (P = .378), Lysholm (P = .402), or Kujala scores (P = .370). Recurrent patellar instability was the most common complication in 21% of knees. Among PSS types, MPFL reconstruction had the lowest rate of RPI (6.5% vs. 27.3% vs. 55.6%; P = .005), and surgical failure (9.7% vs. 31.8% vs. 55.6%; P = .008). Kaplan-Meier survivorship free from surgical failure of the entire cohort was 91.9% at 1 year, 77.7% at 5 years, and 65.7% at 15 years. MPFL reconstruction had the highest survivorship when compared to MPFL repair and other PSS up to 10 years after the index surgery (90.3% vs. 64.1% vs. 27.8%; P = .048). Conclusions: Recurrent patellar instability remains a concern for competitive wrestlers after PSS. MPFL reconstruction may serve as a more durable surgical treatment option with lower rates of RPI and failure when compared to other PSS up to 10 years after surgery. [Table: see text]

Objectives: Baseball pitchers often participate in throwing programs that involve throwing at reduced effort levels to gradually increase the amount of stress experienced across the elbow. It is currently unknown how reduced effort pitching compares to maximum effort with respect to elbow stress and ball velocity. The purpose of this study is to determine whether elbow stress and ball velocity correlate with reduced effort pitching, whether elbow stress and ball velocity decrease proportionally while throwing at a reduced effort, and to assess intrathrower reliability. Methods: Ten healthy male high school baseball pitchers threw 5 pitches from a regulation pitching mound at 3 effort levels: maximum effort, 75% effort, and 50% effort. Elbow stress, specifically elbow varus torque, was calculated for all pitches using a marker-based 3D motion capture system. Ball velocity was measured using a Doppler radar gun. Intrathrower variability was calculated for each effort level. Results: Elbow stress and ball velocity decreased with reduced effort throws (p<0.001 and p=0.003, respectively). However, the reductions in elbow stress and ball velocity were not proportional. At 75% effort throws, elbow stress decreased only 19% and ball velocity decreased only 10%. At 50% effort throws, elbow stress decreased only 25% and ball velocity decreased only 15%. Intrathrower reliability was excellent for elbow stress and ball velocity, with intraclass correlation coefficients all greater than or equal to 0.80. Conclusions: Pitching at a reduced effort level resulted in decreased elbow stress and ball velocity. However, for every 25% reduction in perceived effort, elbow stress decreased by a mean of 13% and ball velocity decreased 8%. When baseball pitchers attempt to throw at a reduced effort of maximum, throwing metrics do not decrease proportionately. While pitching at a reduced effort of maximum decreases elbow stress and ball velocity, the decrease is not proportional, subjecting the elbow to more stress than intended. This has significant clinical importance to pitchers, coaches, and medical professionals in the setting of injury prevention and return to sport. [Table: see text]

Background The first commercialized single-use duodenoscope was cleared by the US Food and Drug Administration in December 2019. Data regarding endoscopic retrograde cholangiopancreatography (ERCP) using a single-use duodenoscope are needed on a broader range of cases conducted by endoscopists with varying levels of experience in a wide range of geographic areas. Methods 61 endoscopists at 22 academic centers in 11 countries performed ERCP procedures in adult patients aged ≥ 18. Outcomes included ERCP completion for the intended indication, rate of crossover to a reusable endoscope, device performance ratings, and serious adverse events (SAEs). Results Among 551 patients, 236 (42.8 %) were aged > 65, 281 (51.0 %) were men, and 256 (46.5 %) had their procedure as an inpatient. ERCPs included 196 (35.6 %) with American Society for Gastrointestinal Endoscopy complexity of grades 3–4. A total of 529 ERCPs (96.0 %) were completed: 503 (91.3 %) using only the single-use duodenoscope, and 26 (4.7 %) with crossover to a reusable endoscope. There were 22 ERCPs (4.0 %) that were not completed, of which 11 (2.0 %) included a crossover and 11 (2.0 %) were aborted cases (no crossover). Median ERCP completion time was 24.0 minutes. Median overall satisfaction with the single-use duodenoscope was 8.0 (scale of 1 to 10 [best]). SAEs were reported in 43 patients (7.8 %), including 17 (3.1 %) who developed post-ERCP pancreatitis. Conclusions In academic medical centers over a wide geographic distribution, endoscopists with varying levels of experience using the first marketed single-use duodenoscope had good ERCP procedural success and reported high performance ratings for this device.

Background: Medial meniscus posterior root tears (MMPRTs) cause pain and dysfunction and are associated with poor clinical outcomes with nonoperative management at short-term follow-up. However, little is known about the long-term natural history of these tears. Purpose: The purpose of this study was to (1) provide an update to a previous minimum 2-year study on the natural progression of these tears and (2) evaluate long-term patient-reported and radiographic outcomes. Study Design: Case series (prognosis); Level of evidence, 4. Methods: A retrospective review was performed on a cohort of patients with untreated MMPRTs, diagnosed between 2005 and 2013, who were followed clinically using International Knee Documentation Committee (IKDC), visual analog scale for pain, and Tegner activity scores as well as radiographically at a minimum 10-year follow-up. Failure was defined as conversion to arthroplasty or a severely abnormal subjective IKDC score <75.4. Results: Overall, 5 (10%) of the original 52 patients with minimum 2-year outcomes were subsequently lost to follow-up. The remaining 47 patients (21 male, 26 female) were followed for a mean of 14 ± 2 years (range, 11-18 years). At final follow-up, 25 patients (53%) had progressed to total knee arthroplasty, 8 (17%) were deceased, and 14 (30%) had not progressed to total knee arthroplasty. The mean IKDC and Tegner activity scores for the 14 patients with remaining MMPRTs were 51.6 ± 22.2 and 3.1 ± 1.1, respectively, and the mean visual analog scale score was 4.4 ± 3.0. Radiographically, the mean Kellgren-Lawrence grade progressed from 1.2 ± 0.7 at baseline to 2.6 ± 0.5 at final follow-up ( P < .001). At a minimum 10-year follow-up, 37 of 39 living patients (95%) had failed nonoperative treatment. Conclusion: Poor clinical and radiographic outcomes were associated with the nonoperative treatment of degenerative MMPRTs at long-term follow-up. This study provides a valuable update on the natural history and long-term prognosis of nonoperatively treated MMPRTs.

Objective: To compare conventional low-temperature storage of transplant donor livers [static cold storage (SCS)] with storage of the organs at physiological body temperature [normothermic machine perfusion (NMP)]. Background: The high success rate of liver transplantation is constrained by the shortage of transplantable organs (eg, waiting list mortality >20% in many centers). NMP maintains the liver in a functioning state to improve preservation quality and enable testing of the organ before transplantation. This is of greatest potential value with organs from brain-dead donor organs (DBD) with risk factors (age and comorbidities), and those from donors declared dead by cardiovascular criteria (donation after circulatory death). Methods: Three hundred eighty-three donor organs were randomized by 15 US liver transplant centers to undergo NMP (n = 192) or SCS (n = 191). Two hundred sixty-six donor livers proceeded to transplantation (NMP: n = 136; SCS: n = 130). The primary endpoint of the study was “early allograft dysfunction” (EAD), a marker of early posttransplant liver injury and function. Results: The difference in the incidence of EAD did not achieve significance, with 20.6% (NMP) versus 23.7% (SCS). Using exploratory, “as-treated” rather than “intent-to-treat,” subgroup analyses, there was a greater effect size in donation after circulatory death donor livers (22.8% NMP vs 44.6% SCS) and in organs in the highest risk quartile by donor risk (19.2% NMP vs 33.3% SCS). The incidence of acute cardiovascular decompensation at organ reperfusion, “postreperfusion syndrome,” as a secondary outcome was reduced in the NMP arm (5.9% vs 14.6%). Conclusions: NMP did not lower EAD, perhaps related to the inclusion of lower-risk liver donors, as higher-risk donor livers seemed to benefit more. The technology is safe in standard organ recovery and seems to have the greatest benefit for marginal donors.

Background: The extent to which recurrent patellar instability (RPI) affects wrestlers has not been thoroughly examined. Purpose: To assess return to wrestling (RTW), patient-reported outcomes, and reoperation rates after patellofemoral stabilization surgery (PFSS) for RPI in a cohort of competitive wrestlers. Study Design: Cohort study; Level of evidence, 3. Methods: All competitive wrestlers with a history of RPI and subsequent PFSS performed at a single institution between 2000 and 2020 were identified. Primary PFSS procedures included medial patellofemoral (MPFL) reconstruction (n = 31; 50%); MPFL repair (n = 22; 35.5%); or other PFSS (n = 9; 14.5%), such as tibial tubercle osteotomy, lateral retinacular release, and/or medial retinacular reefing. Exclusion criteria included revision PFSS or concomitant anterior cruciate ligament reconstruction or multiligament knee injury. Surgical failure was defined as subsequent patellar dislocation despite operative management or need for secondary PFSS. Results: Ultimately, 62 knees in 56 wrestlers with a mean age of 17.0 years (range, 14.0-22.8 years) were included at a mean follow-up of 6.6 years (range, 2.0-18.8 years). RTW occurred in 55.3% of wrestlers at a mean ± SD 8.8 ± 6.7 months. Among PFSS types, no differences were observed in rates of RTW ( P = .676), postoperative pain ( P = .176), Tegner activity level ( P = .801), International Knee Documentation Committee ( P = .378), Lysholm ( P = .402), or Kujala scores ( P = .370). RPI was the most common postoperative complication (n = 13; 21.0%). MPFL reconstruction had the lowest rate of RPI (6.5% vs 27.3% [repair] vs 55.6% [other]; P = .005) and surgical failure (9.7% vs 31.8% [repair] vs 55.6% [other]; P = .008). Kaplan-Meier survivorship free from surgical failure of the entire cohort was 91.9% at 1 year, 77.7% at 5 years, and 65.7% at 15 years. MPFL reconstruction had the highest survivorship when compared with MPFL repair and other PFSS up to 10 years after the index surgery (90.3% vs 64.1% vs 27.8%; P = .048). Conclusion: RPI remains a concern for competitive wrestlers after PFSS. MPFL reconstruction may serve as a more durable surgical treatment option with lower rates of RPI and failure when compared with other PFSS procedures at up to 10 years after surgery.