Operational and Institutional Recommendations and Requirements for TAVR: A Review of Expert Consensus and the Impact on Health Care Policy.

When transcatheter aortic valve replacement (TAVR) was first approved for use in the United States in 2012, multiple leading surgical and cardiology societies were tasked with creating recommendations and requirements for operators and institutions starting and maintaining TAVR programs. Creation of this consensus document was challenging due to limited experience with this new technology, and a lack of robust centralized data that could be used to validate outcome measures and create benchmarks for self-assessment and improvement. Despite these limitations, this document provided government agencies a framework for regulation that ultimately determined requirements for Medicare payment for TAVR and therefore greatly determined how and where care was delivered for patients with aortic stenosis. After the proliferation of TAVR institutions throughout the US and with data from more than 100,000 cases in the STS/ACC Transcatheter Valve Therapies TM Registry, leaders of the same societies reconvened in 2018 to update their consensus document. The new recommendations include suggested personnel, facilities, training, and assessment of outcomes and competencies required to run a safe and efficient TAVR program. This article seeks to detail the changes from the original consensus document with a particular focus on issues relevant to cardiac anesthesiologists as well as important healthcare policy ramifications for patients and providers in the United States.

Gait Analysis After Intertrochanteric Hip Fracture: Does Shortening Result in Gait Impairment?

OBJECTIVE: To determine the association between fracture collapse with altered gait after intertrochanteric (IT) fracture using the trochanteric fixation nail (TFN) and helical blade. DESIGN: Prospective cohort study. SETTING: Academic Level I trauma center. PATIENTS: Seventy-two patients with IT hip fractures (OTA/AO 31) treated between 2012 and 2016. The average age was 79.7 years (range, 51-94 years); there were 59 women and 13 men. INTERVENTION: All patients were treated with cephalomedullary nailing using the TFN (DePuy-Synthes, West Chester, PA) with a helical blade. MAIN OUTCOME MEASURES: At follow-up appointments, temporospatial gait parameters were measured and recorded. Radiographs were analyzed at the time of surgery and at each follow-up visit. Amount of radiographic femoral neck shortening was measured radiographically. Patients completed the Harris Hip Score, visual analog scale for pain, Short Form-36 Physical Component Score, and Short Form-36 Mental Component Score. RESULTS: The mean length of follow-up between the surgery and the gait analysis was 8.6 months (±0.7 months). The mean amount of shortening was 4.7 mm (±0.6 mm). Out of the 72 patients analyzed, there were 15 patients (20.8%) who shortened more than 8 mm, 7 patients (9.7%) who shortened 10 mm or more, and 2 patients (2.8%) who shortened more than 20 mm. Mean shortening was 3.0 mm for stable OTA/AO 31-A1 fractures, whereas the unstable patterns (OTA/AO 31-A2, 31-A3) demonstrated a mean shortening of 5.9 mm (P = 0.02). There was significant correlation between increased shortening and decreased cadence (P = 0.008), increased double support time (P < 0.001), decreased step length (P = 0.001), and increased single support asymmetry (P = 0.04) during gait analysis. The threshold of 8 mm of shortening predicted decreased cadence (P = 0.008), increased double support time (P < 0.001), and decreased step length (P = 0.006). Analysis of patient-reported outcome scores, including the Harris Hip Score, visual analog scale, SF-36 Physical Component Score, and SF-36 Mental Component Score, revealed no significant association with shortening. CONCLUSIONS: Results from this study indicate that shortening after cephallomedullary nailing of IT hip fractures using the TFN with a helical blade is associated with altered gait, specifically decreased cadence, increased double support time, decreased step length, and increased single support time asymmetry. LEVEL OF EVIDENCE: Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.

Computerized Adaptive Testing for Patient Reported Outcomes in Ankle Fracture Surgery.

BACKGROUND: Advantages of using computerized adaptive testing (CAT) include decreased survey-burden, diminished floor and ceiling effect, and improved ability to detect the minimal clinical significant difference (MCID) among patients. The goal of this study was to compare the legacy patient-reported outcome measures (PROMs) to the Patient-Reported Outcomes Measurement Information System (PROMIS) scores in terms of ability to detect clinically significant changes in patients who have undergone surgery for ankle fractures. METHODS: Patients who underwent osteosynthesis for an unstable ankle fracture between 2013-2016 and completed legacy outcome scores (Foot and Ankle Outcome Score [FAOS], Olerud and Molander Ankle Score [OMAS], and Weber Score) along with the PROMIS Physical Function (PF) and PROMIS Lower Extremity (LE) CATs postoperatively were included. Correlation between the scores at 3-month, 6-month, and 1-year intervals, as well as floor and ceiling effects, in addition to MCIDs were calculated for each instrument. A total of 132 patients were included in the study. RESULTS: There was no observed floor or ceiling effect in either the PROMIS PF or the PROMIS LE scores. Clinically significant changes in the PROMIS LE score were detected in patients between 6-month and 12-month postoperative visits ( P = .0006), whereas the reported OMAS score and Weber scores did not identify a clinically significant difference between patients at their 6-month and 12-month visit. CONCLUSION: The results of this study indicate that the PROMIS LE was superior for evaluating patients following ankle fracture surgery in terms of lower floor and ceiling effects and greater ability to distinguish clinically significant changes in patients between time points following surgery. LEVEL OF EVIDENCE: Level III, comparative study.

Validating the Patient Reported Outcomes Measurement Information System (PROMIS) computerized adaptive tests for upper extremity fracture care.

BACKGROUND: Computerized adaptive testing (CAT) for patient-reported outcomes (PROs) is a developing area within orthopedic surgery. Our objective was to validate the Patient Reported Outcomes Measurement Information System (PROMIS) CATs for upper extremity fracture care. We sought to correlate PROMIS with legacy PROs and to investigate floor and ceiling effects. METHODS: Patients who underwent open reduction and internal fixation of upper extremity trauma were prospectively enrolled. Legacy PROs included the visual analog scale for pain, the Disabilities of the Arm, Shoulder and Hand questionnaire, the University of California-Los Angeles Shoulder Rating Scale, the Mayo Elbow Performance Score, and the 36-Item Short Form Health Survey. PROMIS CATs included Physical Function (PROMIS PF), PROMIS Pain Interference (PROMIS Pain), and PROMIS Upper Extremity (PROMIS UE). Correlations between the PROs were calculated as were the absolute and relative floor and ceiling effect. RESULTS: The study prospectively enrolled 174 patients with upper extremity trauma. There was moderate to high correlation between PROMIS UE CAT and legacy upper extremity-specific PROs (ρ = 0.42-0.79), and high correlation between the PROMIS PF CAT and the 36-Item Short Form Health Survey Physical Component Summary (ρ = 0.71, P < .001). The visual analog scale for pain, University of California-Los Angeles Shoulder Rating Scale, Constant Score, and Mayo Elbow Score demonstrated a significant absolute ceiling effect (20.5%-23.7%), whereas the PROMIS PF, PROMIS UE, and PROMIS Pain CATs demonstrated no absolute ceiling effect. CONCLUSION: PROMIS PF, Pain, and UE correlate well with legacy PROs in a upper extremity trauma population, with less absolute floor or ceiling effects. This study provides preliminary evidence for the utility of PROMIS CATs in upper extremity trauma patients.

Imiquimod Injection to Rabbit Vocal Folds: A Preliminary, Preclinical Investigation.

Objective Given the recalcitrant nature of recurrent respiratory papillomatosis, targeted therapies to reduce disease burden are fundamental to improved patient care paradigms. We seek to demonstrate the safety of imiquimod injection into vocal fold mucosa by evaluating the degree of laryngeal edema, histopathologic changes to vocal fold structure, and serologic interferon α (IFNα) levels following injection. Study Design Preclinical. Setting Academic institution. Subjects and Methods Six New Zealand White rabbits underwent unilateral injection of 100 µg of sterile imiquimod (1 µg/µL), with 100 µL of normal saline injected into the contralateral vocal fold. Direct laryngoscopy was performed on days 3, 7, and 30 following injection. Larynges from 3 rabbits were harvested on postinjection day 7 for histologic analysis. The remaining 3 rabbit larynges were harvested on day 30. Serial serum samples were drawn for IFNα quantification via immunoassay. Results No signs of respiratory distress were observed at any point. Vocal fold appearance was not clinically divergent between imiquimod and control conditions via serial direct laryngoscopic evaluation. No inflammatory lesions or scarring were identified following injection. Histology showed no signs of acute inflammatory processes or changes in the control or imiquimod injection groups. Serum IFNα increased at days 3 and 7 following imiquimod injection ( P < .0001 and P = .0368, respectively), before returning to baseline by day 14. Conclusions Vocal fold imiquimod injection did not result in notable morbidity in this preclinical model. However, serum IFNα concentrations increased transiently. These data are critical to advance the therapeutic utility of this compound, particularly in the setting of recurrent respiratory papillomatosis.

Cohesinopathies of a feather flock together.

Roberts Syndrome (RBS) and Cornelia de Lange Syndrome (CdLS) are severe developmental maladies that present with nearly an identical suite of multi-spectrum birth defects. Not surprisingly, RBS and CdLS arise from mutations within a single pathway--here involving cohesion. Sister chromatid tethering reactions that comprise cohesion are required for high fidelity chromosome segregation, but cohesin tethers also regulate gene transcription, promote DNA repair, and impact DNA replication. Currently, RBS is thought to arise from elevated levels of apoptosis, mitotic failure, and limited progenitor cell proliferation, while CdLS is thought to arise, instead, from transcription dysregulation. Here, we review new information that implicates RBS gene mutations in altered transcription profiles. We propose that cohesin-dependent transcription dysregulation may extend to other developmental maladies; the diagnoses of which are complicated through multi-functional proteins that manifest a sliding scale of diverse and severe phenotypes. We further review evidence that cohesinopathies are more common than currently posited.