Patient Selection Factors Research Articles

Safety and feasibility of robotic surgery in geriatric patients with rectal cancer.

The incidence of rectal cancer is increasing in the elderly population, yet the safety of surgical interventions in this group, particularly robotic surgery, is still debated. This study aims to investigate the safety and short-term postoperative outcomes of robotic surgery in geriatric patients (aged ≥ 70years) with rectal cancer. Patients diagnosed with rectal cancer and undergoing robotic surgery between March 2021 and September 2023 were divided into two groups based on age: the elderly group (aged ≥ 70years) and the younger group (aged < 70years), totaling 108 patients. The study included 80 younger patients in group 1 and 28 elderly patients in group 2. The groups had similar gender distribution and tumor characteristics. The elderly group had higher ASA scores and lower albumin levels and underwent the Miles procedure more frequently. The stoma rate was higher in the elderly group. Operation duration, tumor diameter, lymph node dissection numbers, pathological stage, and other histopathological features were similar in the two groups. Postoperative outcomes like hospital stay, complication rates, anastomotic leakage, reoperation rates, unplanned readmissions, and mortality were comparable between the groups. Robotic surgery for rectal cancer in elderly patients is technically feasible and safe. Age should not be a determining factor in patient selection for robotic surgery or be considered a risk factor for postoperative complications.

Key Imaging Factors for Transcatheter Management of Tricuspid Regurgitation: Device and Patient Selection

The growing awareness of tricuspid regurgitation (TR) and the fast-expanding array of devices aiming to percutaneously repair or replace the tricuspid valve have underscored the central role of multi-modality imaging in comprehensively assessing the anatomical and functional characteristics of TR. Accurate phenotyping of TR, the right heart, and pulmonary vasculature via echocardiography, computed tomography, and, occasionally, cardiovascular magnetic resonance and right heart catheterization is deemed crucial in choosing the most suitable treatment strategy for each patient and achieving procedural success. In the first part of the present review, key imaging factors for patient selection will be discussed. In the ensuing sections, an overview of the most commonly used, commercially available systems for transcatheter repair/replacement will be presented, along with their respective selection criteria and information on intraprocedural imaging guidance; these are edge-to-edge repair, orthotopic and heterotopic replacement, and valve-in-valve procedures.

Day case laparoscopic cholecystectomy: a review of patient selection factors and identification of potential barriers to same-day discharge.

Day-case laparoscopic cholecystectomy (DCLC) is a useful tool for minimizing hospital admissions and prolonged presurgical wait times in suitable patient cohorts. There have been many international studies to support this finding and an increasing interest has grown in implementation in Australia. This review aims to provide clarity how to best implement this tool in gallbladder disease patient demographic. This literature review evaluates studies on day-case cholecystectomy procedures, focusing on patient factors, procedural aspects, surgical morbidity, and systemic implications. It explores inclusion and exclusion criteria for day-case suitability, factors influencing same-day discharge, reasons for hospital admission, pain management, patient quality of life, patient satisfaction, and cost implications. DCLC, when selected judiciously, is a safe alternative to overnight stay procedures for cholecystectomy with comparable surgical outcomes and patient satisfaction, affirming its viability. Strict patient selection criteria can aid in optimizing the successful implementation procedure, reducing unexpected admissions and readmissions and we have demonstrated useful criteria for guidance in establishing day-case laparoscopic cholecystectomy protocol at a hospital.

Age as a Mortality Predictor in ECPR Patients.

Extracorporeal cardiopulmonary resuscitation (ECPR) is an advanced technique using extracorporeal membrane oxygenation (ECMO) to support patients with refractory cardiac arrest. Age significantly influences ECPR outcomes, with younger patients generally experiencing better survival and neurological outcomes due to many aspects. This review explores the impact of age on ECPR effectiveness, emphasizing the need to consider age alongside other clinical factors in patient selection. Survival rates differ notably between in-hospital (IHCA) and out-of-hospital cardiac arrest (OHCA), highlighting the importance of rapid intervention. The potential of artificial intelligence to develop predictive models for ECPR outcomes is discussed, aiming to improve decision-making. Ethical considerations around age-based treatment decisions are also addressed. This review advocates for a balanced approach to ECPR, integrating clinical and ethical perspectives to optimize patient outcomes across all age groups.

Lnsights into Adjuvant Systemic Treatment Selection for Patients with Stage III Melanoma: Data from the Dutch Cancer Registry.

Patient demographics and shared decision making might influence the choice of adjuvant therapy for stage III melanoma. To identify factors for treatment selection of patients diagnosed with stage III melanoma to better understand current treatment decisions and improve further treatment counseling. Data from 2007 patients diagnosed with stage III melanoma, between December 2018 and 2021, sourced from the Dutch Cancer Registry, were analyzed. Among the cohort, 48.7% received no therapy, 45.8% received checkpoint inhibition, and 5.5% received targeted therapy (TT). Patients foregoing therapy were significantly older [67.0 years (range 53.0-77.0) vs. 62.0 year (range 52.0-72.0)], had poorer performance scores (PS), and higher Charlson Comorbidity Index scores compared to those receiving therapy (p<0.001). Patients undergoing therapy had significantly higher median Breslow thickness (3.3mm vs. 2.2mm) and higher prevalence of ulceration (49.9% vs. 38.1%). Those with connective tissue disease and/or congestive heart disease were more likely to receive TT [odds ration (OR) 8.1; 95% confidence interval (CI) 1.7-37.6 and OR 9.3; 95% CI 1.2-72.2, respectively]. Median treatment time among strata for disease recurrence was 4.26months (3.69-4.82) for immunotherapy and 3.1months (0.85-5.36) for TT (p=0.298). Patients who developed recurrent disease were equal across treatment types (p=0.656). The number of patients with grade 3 complications was different for each treatment type [immunotherapy: 17.8% vs. TT: 37.3% (p<0.001)]. Age, PS, and Breslow thickness seem to influence adjuvant treatment decisions. Clinicians' preference for immunotherapy might play a role in counseling BRAF-positive patients for adjuvant therapy, this however, cannot be confirmed in this dataset. Overall, only a small proportion of patients completed adjuvant treatment.

Understanding risk factors for revision surgery after cubital tunnel release: Analysis of patient selection, surgeon, and clinical factors

PurposeThe purpose of this study was to identify and characterize factors that may contribute to revision surgery following primary cubital tunnel release (CuTR) surgery. MethodsA retrospective study was performed by reviewing all patients who underwent CuTR at a single institution between 2014 and 2021. Only primary in situ CuTR surgeries were included. Exclusion criteria were any case of primary ulnar nerve transpositions or ulnar nerve decompression surgery related to pathology other than isolated ulnar neuropathy (ie. elbow fracture repair, medial epicondylitis debridement, etc.). Revision surgery was defined as return to the operating room by the index surgeon or another surgeon within the same practice for repeat ulnar nerve decompression and/or transposition. Patient demographics and surgical information was analyzed to determine factors that may be associated with revision surgery following primary in situ ulnar nerve decompression. ResultsA total of 1367 patients met inclusion criteria. Revision rate following primary CuTR was 1.2 ​% (n ​= ​16). Of the factors evaluated, younger age (46.6 vs 57.0 years) and a history of cervical stenosis had a higher correlation with undergoing a revision. Patients who had revision surgery were more likely to have negative electrodiagnostic studies versus those who did not. Otherwise, there was no association between sex, race, tobacco use, medical comorbidities, symptom severity, bilateral symptoms, or concurrent surgery and the subsequent need for revision ulnar nerve decompression. ConclusionsFollowing primary in situ CuTR, younger age or a history of cervical stenosis may be at higher risk of undergoing revision surgery. Additionally, patients without electrodiagnostic evidence of ulnar neuropathy may have less reliable outcomes versus those who have a positive nerve study. Given the unpredictable nature of ulnar nerve surgery, further prospective data including diagnostic imaging and biomechanical evaluation of patients following ulnar nerve release may help provide a deeper understanding of this unique patient population. Level of evidencePrognostic, level IV.

Multidisciplinary Management of Isocitrate Dehydrogenase-Mutated Gliomas in a Contemporary Molecularly Defined Era.

Mutations in isocitrate dehydrogenase (IDH) genes, an early step in the ontogeny of lower-grade gliomas, induce global epigenetic changes characterized by a hypermethylation phenotype and are critical to tumor classification, treatment decision making, and estimation of patient prognosis. The introduction of IDH inhibitors to block the oncogenic neomorphic function of the mutated protein has resulted in new therapeutic options for these patients. To appreciate the implications of these recent IDH inhibitor results, it is important to juxtapose historical outcomes with chemoradiotherapy. Herein, we rationally evaluate recent IDH inhibitor data within historical precedents to guide contemporary decisions regarding the role of observation, maximal safe resection, adjuvant therapies, and the import of patient and tumor variables. The biological underpinnings of the IDH pathway and the mechanisms, impact, and limitations of IDH inhibitors, the actual magnitude of tumor regression and patient benefit, and emergence of resistance pathways are presented to guide future trial development. Management in the current, molecularly defined era will require careful patient selection and risk factor assessment, followed by an open dialog about the results of studies such as INDIGO, as well as mature data from legacy trials, and a discussion about risk-versus-benefit for the choice of treatment, with multidisciplinary decision making as an absolute prerequisite.

Imaging-based diagnosis of sarcopenia for transplant-free survival in primary sclerosing cholangitis

BackgroundImaging-based assessment of sarcopenia is a well-validated prognostic tool for patients with chronic liver disease. However, little is known about its value in patients with primary sclerosing cholangitis (PSC). This cross-sectional study aimed to investigate the predictive value of the cross-sectional imaging-based skeletal muscle index (SMI) for transplant-free survival (TFS) in patients with PSC.MethodsA total of 95 patients with PSC who underwent abdominal cross-sectional imaging between 2008 and 2022 were included in this retrospective study. SMI was measured at the third lumbar vertebra level (L3-SMI). The cut-off values to define sarcopenia were < 50 cm²/m² in male patients and < 39 cm²/m² in female patients. The primary outcome of this study was TFS, which was defined as survival without liver transplantation or death from any cause.ResultsOur study indicates that L3-SMI sarcopenia impairs TFS in patients with PSC (5-year TFS: 33.9% vs. 83.3%, p = 0.001, log-rank test). L3-SMI sarcopenia was independently associated with reduced TFS via multivariate Cox regression analysis (HR = 2.749; p = 0.028). Body mass index reduction > 10% at 12 months, which is used as MELD standard exception (SE) criterion in Eurotransplant (in Germany only until September 2023), was not significantly associated with TFS in the multivariate Cox regression analysis (HR = 1.417; p = 0.330). Substitution of BMI reduction with L3-SMI in the German SE criteria improved the predictive accuracy of TFS compared to the established SE criteria (multivariable Cox regression analysis: HR = 4.007, p < 0.001 vs. HR = 1.691, p = 0.141).ConclusionImaging-based diagnosis of sarcopenia via L3-SMI is associated with a low TFS in patients with PSC and may provide additional benefits as a prognostic factor in patient selection for liver transplantation.

Generalizability of predictive models for Clostridioides difficile infection, severity and recurrence at an urban safety-net hospital

IntroductionPredictive models for Clostridioides difficile (C. difficile) infection can identify high risk patients and aid clinicians in preventing infection. Issues of generalisability regarding current predictive models have been acknowledged but to our knowledge have never been quantified. MethodsThrough case-control sampling from an urban safety-net hospital, we created C. difficile infection, severity, and recurrence predictive models using multivariate logistic regression. Models were validated using 5-fold cross-validation and inverse probability weights (IPW) based on two different catchment area definitions were used to improve external validity. Akaike Information Criterion (AIC), area under the receiver operating characteristic curve (AUROC), sensitivity, and specificity with bootstrapped confidence intervals were used to assess and compare model fit and performance. ResultsChanges in performance before and after weighting were small across all models; although, differences were more apparent after weighting the recurrence model (AUROCs of 0.78, 0.76, 0.71 for the unweighted and two weighted models, respectively). Overall, the infection model performed the best (AUROC=0.82 [95%CI: 0.78, 0.85]) followed by the recurrence model (AUROC=0.78 [95%CI: 0.69, 0.86]) and then the severity model (AUROC=0.70 [95%CI: 0.63, 0.78]. ConclusionsThe performance of our models after weighting did not change drastically suggesting that our model predicting C. difficile infection, severity, and recurrence may not be impacted by patient selection factors; however, other researchers may want to consider addressing these catchment forces using IPW.

Multimodality assessment of the coronary microvasculature with TIMI frame count versus perfusion PET highlights coronary changes characteristic of coronary microvascular disease.

The diagnosis of coronary microvascular disease (CMVD) remains challenging. Perfusion PET-derived myocardial blood flow (MBF) reserve (MBFR) can quantify CMVD but is not widely available. Thrombolysis in Myocardial Infarction (TIMI) frame count (TFC) is an angiography-based method that has been proposed as a measure of CMVD. Here, we compare TFC and PET-derived MBF measurements to establish the role of TFC in assessing for CMVD. We use coronary modeling to elucidate the relationship between MBFR and TFC and propose TFC thresholds for identifying CMVD. In a cohort of 123 individuals (age 58 ± 12.1, 63% women, 41% Caucasian) without obstructive coronary artery disease who had undergone perfusion PET and coronary angiography for clinical indications, we compared TFC and perfusion PET parameters using Pearson correlation (PCC) and linear regression modeling. We used mathematical modeling of the coronary circulation to understand the relationship between these parameters and performed Receiver Operating Curve (ROC) analysis. We found a significant negative correlation between TFC and MBFR. Sex, race and ethnicity, and nitroglycerin administration impact this relationship. Coronary modeling showed an uncoupling between TFC and flow in epicardial vessels. In ROC analysis, TFC performed well in women (AUC 0.84-0.89) and a moderately in men (AUC 0.68-0.78). We established an inverse relationship between TFC and PET-derived MBFR, which is affected by patient selection and procedural factors. TFC represents a measure of the volume of the epicardial coronary compartment, which is increased in patients with CMVD, and performs well in identifying women with CMVD.

Blalock-Taussig Shunt versus Ductal Stenting as Palliation for Duct-Dependent Pulmonary Circulation.

There is limited data published from outside North America and Europe comparing the outcomes of a modified Blalock-Taussig shunt (MBTS) and ductal stenting as the first palliative procedure for infants with duct-dependent pulmonary circulation. This study reports the National Heart Center's, in Muscat, Oman, experience in comparing the outcomes of these 2 interventions. This retrospective study included all infants with duct-dependent pulmonary circulation who received either a MBTS or ductal stenting from 2016-2019. The primary outcomes were death or re-interventions. Secondary outcomes included death, subsequent re-interventions, survival to subsequent surgical intervention, survival to hospital discharge, post-procedural mechanical ventilation and duration of intensive care unit stay. A total of 71 patients were included in the study, 33 (46%) of whom received ductal stenting. The prevalence of the primary outcome (death or re-intervention) in the patent ductus arteriosus (PDA) stent group was 54.5% versus 31.6% in the MBTS group but this was not statistically significant (P = 0.06). There was no difference between the 2 groups in terms of time to next surgical intervention (P = 0.233). The PDA stent group had shorter post-procedural, mechanical ventilation and intensive care unit stay durations (P <0.05). Syndromic patients were at higher risk of mortality compared to non-syndromic patients. MBTS and ductal stenting are both acceptable modalities as a palliative intervention for infants with duct-dependant pulmonary circulation. Syndromic patients are at higher risk of mortality. This can be considered an important factor for patient selection.

Current Practices in Hepatic Artery Infusion (HAI) Chemotherapy: An International Survey of the HAI Consortium Research Network.

An increasing number of hepatic artery infusion (HAI) programs have been established worldwide. Practice patterns for this complex therapy across these programs have not been reported. This survey aimed to identify current practice patterns in HAI therapy with the long-term goal of defining best practices and performing prospective studies. Using SurveyMonkeyTM, a 28-question survey assessing current practices in HAI was developed by 12 HAI Consortium Research Network (HCRN) surgical oncologists. Content analysis was used to code textual responses, and the frequency of categories was calculated. Scores for rank-order questions were generated by calculating average ranking for each answer choice. Thirty-six (72%) HCRN members responded to the survey. The most common intended initial indications for HAI at new programs were unresectable colorectal liver metastases (uCRLM; 100%) and unresectable intrahepatic cholangiocarcinoma (uIHC; 56%). Practice patterns evolved such that uCRLM (94%) and adjuvant therapy for CRLM (adjCRLM; 72%) have become the most common current indications for HAI at established centers. Referral patterns for pump placement differed between uCRLM and uIHC, with most patients referred while receiving second- and first-line therapy, respectively, with physicians preferring to evaluate patients for HAI while receiving first-line therapy for CRLM. Concern for extrahepatic disease was ranked as the most important factor when considering a patient for HAI. Indication and patient selection factors for HAI therapy are relatively uniform across most HCRN centers. The increasing use of adjuvant HAI therapy and overall consistency of practice patterns among HCRN centers provides a robust environment for prospective data collection and randomized clinical trials.

The ablative effect of mitomycin reverse thermal gel: Expanding the role for nephron preservation therapy in low grade upper tract urothelial carcinoma.

Assess the real-world ablative effect of mitomycin reverse thermal gel for low-grade upper tract urothelial carcinoma (UTUC) in patients who undergo biopsy only or partial ablation and evaluate utility of complete ablation prior to UGN-101. We retrospectively reviewed low-grade UTUC patients treated with UGN-101 from 15 high-volume centers. Patients were categorized based on initial endoscopic ablation (biopsy only, partial ablation, or complete ablation) and by size of remaining tumor (complete ablation, <1cm, 1-3cm, or >3cm) prior to UGN-101. The primary outcome was rendered disease free (RDF) rate at first post-UGN-101 ureteroscopy (URS), defined as complete response or partial response with minimal mechanical ablation to endoscopically clear the upper tract of visible disease. One hundred and sixteen patients were included for analysis after excluding those with high-grade disease. At first post-UGN-101 URS, there were no differences in RDF rates between those who at initial URS (pre-UGN-101) had complete ablation (RDF 77.0%), partial ablation (RDF 55.9%) or biopsy only (RDF 66.7%) (P = 0.14). Similarly, a complimentary analysis focusing on tumor size (completely ablated, <1cm, 1-3cm or >3cm) prior to UGN-101 induction did not demonstrate significant differences in RDF rates (P = 0.17). The results of the early real-world experience suggest that UGN-101 may play a role in initial chemo-ablative cytoreduction of larger volume low-grade tumors that may not initially appear to be amenable to renal preservation. Further studies will help to better quantify the chemo-ablative effect and to identify clinical factors for patient selection.

Surgical strategy for colorectal cancer with synchronous liver and extrahepatic metastases: A scoring system and decision tree model.

The role of hepatectomy in a specific group of patients with synchronous colorectal cancer with liver metastases (SCRLM) and synchronous extrahepatic disease (SEHD) is still unclear. The aim of this study was to evaluate the efficacy of liver surgery and define the selection criteria for surgical candidates in patients with SCRLM + SEHD. Between July 2007 and October 2018, 475 patients with colorectal cancer with liver metastases (CRLM) who underwent liver resection were retrospectively reviewed. Sixty-five patients with SCRLM + SEHD were identified and included in the study. Clinical pathological data of these patients were analyzed to evaluate the influence on survival. Important prognostic factors were identified by univariate and multivariate analyses. The risk score system and decision tree analysis were generated according to the important prognostic factors for better patient selection. The 5-year survival rate of patients with SCRLM + SEHD was 21.9%. The most important prognostic factors were SCRLM number of more than five, site of SEHD other than the lung only, inability to achieve SCRLM + SEHD R0 resection, and BRAF mutation of cancer cells. The proposed risk score system and decision tree model easily discriminated between patients with different survival rates and identified the profile of suitable surgical patients. Liver surgery should not be a contraindication for patients with SCRLM + SEHD. Patients with complete SCRLM + SEHD R0 resection, SCRLM number less than or equal to five, SEHD confined to the lung only, and wild-type BRAF could have favorable survival outcomes. The proposed scoring system and decision tree model may be beneficial to patient selection in clinical use.

Adherence to Society for Vascular Surgery Guidelines for Claudication in the Society for Vascular Surgery Vascular Quality Initiative

Current Society for Vascular Surgery (SVS) guidelines recommend 51 specific factors related to the management of intermittent claudication as quality measures. It was the objective of this study to assess rates of adherence to these guidelines for patients treated with suprainguinal or infrainguinal bypass or percutaneous vascular intervention and to determine if this was associated with a difference in the periprocedural outcomes. All patients from the SVS Vascular Quality Initiative (VQI) undergoing infrainguinal bypass (INFRA), suprainguinal bypass (SUPRA), and percutaneous vascular intervention (PVI) for claudication from 2018 were included. Nonelective procedures for other than chronic atherosclerotic disease were excluded. The rates of adherence to each assessable guideline were evaluated. For outcomes analysis, individuals were classified as “adherent” to the guidelines vs not and compared. Of the 51 SVS recommendations, 12 could be evaluated using VQI registries; these included first-line ankle-brachial index, smoking cessation, statin therapy, antiplatelet therapy with aspirin, optimal medical therapy after intervention, anatomic imaging studies before intervention, optimizing diabetes control, Plavix as second-line antiplatelet, adjunct stenting in intermediate superficial femoral artery lesions, annual follow-up, covered stents for the treatment of aortoiliac disease, and no recommended endovascular treatment for isolated infrapopliteal disease. The rates of overall “adherence” were 38.2% for INFRA, 17.1% for SUPRA, and 32.2% for PVI. There were a surprising number of isolated tibial (n = 1431, 3.1%) and pedal (n = 12, 0.03%) endovascular interventions performed for claudication. There were 784 tibial bypasses (19.3%), 30 (0.7%) at the ankle, 2 of which were tarsal/plantar bypasses for claudication. It appears that for the most part, there do not seem to be important clinical differences in outcomes based on the study definition of adherence for all outcomes assessed. Among factors such as survival (Fig 1), time to amputation (Fig 2), primary patency (Fig 3), and time to reoperation/reintervention for occlusion (Fig 4) for INFRA, SUPRA, and PVI, there were no differences between individuals meeting the study definition of adherence vs those not adherent for all outcomes was assessed. Overall adherence rates to SVS guidelines for the management of intermittent claudication are low and may be an opportunity for improvement in patient outcomes. An absence of differences noted in this study may reflect unmeasured factors in patient selection or in outcomes. Adding more of the SVS recommendations for the management of intermittent claudication to the VQI registry may serve as a future focus for quality improvement projects.

The James A. Rand Young Investigator's Award: Increased Revision Risk With Mobile Bearings in Total Knee Arthroplasty: An Analysis of the American Joint Replacement Registry

BackgroundMobile-bearing (MB) total knee arthroplasty (TKA) may reduce wear and improve patellar tracking but may increase revision risk due to tibial component design, balance complexity, and bearing dislocation. We utilized the American Joint Replacement Registry to examine risk of revision with MB compared to fixed-bearing (FB) designs. MethodsAn analysis of primary TKA in patients over 65 years was performed with American Joint Replacement Registry data linked to Centers for Medicare and Medicaid Services data from 2012 to 2019. Analyses compared MB to FB designs with a subanalysis of implants from a single company. We identified 485,024 TKAs, with 452,199 (93.2%) FB-TKAs and 32,825 (6.8%) MB-TKAs. Cox proportional hazards regression modeling was used for all-cause revision and revision for infection, adjusting for sex, age, and competing risk of mortality. Event-free survival curves evaluated time to all-cause revision and revision for infection. ResultsMB-TKAs were at an increased risk for all-cause revision: hazard ratio (HR) 1.36 ([95% confidence interval (CI) 1.24-1.49], P < .0001) but not revision for infection: HR 1.06 ([95% CI 0.90-1.25], P = .52). When comparing implants within a single company, MB-TKAs were at an increased risk of all-cause revision: HR 1.55 ([95% CI 1.38-1.73], P < .0001). Event-free survival curves demonstrated increased risk for all-cause revision for MB-TKA across all time points, with a greater magnitude of risk up to 8 years. ConclusionAlthough survivorship of both designs was outstanding, MB-TKA designs demonstrated increased risk for all-cause revision. Additional investigation is needed to determine if this is related to patient selection factors, surgical technique, bearing, or implant design.

High-volume Arthroplasty Centers Are Associated With Lower Hospital Costs When Performing Primary THA and TKA: A Database Study of 288,909 Medicare Claims for Procedures Performed in 2019.

With bundled payments and alternative reimbursement models expanding in scope and scale, reimbursements to hospitals are declining in value. As a result, cost reduction at the hospital level is paramount for the sustainability of profitable inpatient arthroplasty practices. Although multiple prior studies have investigated cost variation in arthroplasty surgery, it is unknown whether contemporary inpatient arthroplasty practices benefit from economies of scale after accounting for hospital characteristics and patient selection factors. Quantifying the independent effects of volume-based cost variation may be important for guiding future value-based health reform. We performed this study to (1) determine whether the cost incurred by hospitals for performing primary inpatient THA and TKA is independently associated with hospital volume and (2) establish whether length of stay and discharge to home are associated with hospital volume. The primary data source for this study was the Medicare Provider Analysis and Review Limited Data Set, which includes claims data for 100% of inpatient Medicare hospitalizations. We included patients undergoing primary elective inpatient THA and TKA in 2019. Exclusion criteria included non-Inpatient Prospective Payment System hospitalizations, nonelective admissions, bilateral procedures, and patients with cancer of the pelvis or lower extremities. A total of 500,658 arthroplasties were performed across 2762 hospitals for 492,262 Medicare beneficiaries during the study period; 59% (288,909 of 492,262) of procedures were analyzed after the exclusion criteria were applied. Most exclusions (37% [182,733 of 492,262]) were because of non-Inpatient Prospective Payment System hospitalizations. Among the study group, 87% (251,996 of 288,909) of procedures were in patients who were 65 to 84 years old, 88% (255,415 of 288,909) were performed in patients who were White, and 63% (180,688 of 288,909) were in patients who were women. Elixhauser comorbidities and van Walraven indices were calculated as measures of patient health status. Hospital costs were estimated by multiplying cost-to-charge ratios obtained from the 2019 Impact File by total hospital charges. This methodology enabled us to use the large Medicare Provider Analysis and Review database, which helped decrease the influence of random cost variation through the law of large numbers. Hospital volumes were calculated by stratifying claims by national provider identification number and counting the number of claims per national provider identification number. The data were then grouped into bins of increasing hospital volume to more easily compare larger-volume and smaller-volume centers. The relationship between hospital costs and volume was analyzed using univariable and multivariable generalized linear models. Results are reported as exponential coefficients, which can be interpreted as relative differences in cost. The impact of surgical volume on length of stay and discharge to home was assessed using binary logistic regression, considering the nested structure of the data, and results are reported as odds ratios (OR). Hospital cost and mean length of stay decreased, while rates of discharge to home increased with increasing hospital volume. After controlling for potential confounding variables such as patient demographics, health status, and geographic location, we found that inpatient arthroplasty costs at hospitals with 10 or fewer, 11 to 100, and 101 to 200 procedures annually were 1.32 (95% confidence interval [CI] 1.30 to 1.34; p < 0.001), 1.17 (95% CI 1.17 to 1.17; p < 0.001), and 1.10 (95% CI 1.10 to 1.10; p < 0.001) times greater than those of hospitals with 201 or more inpatient procedures annually. In addition, patients treated at smaller-volume hospitals had increased odds of experiencing a length of stay longer than 2 days (OR 1.25 to 3.44 [95% CI 1.10 to 4.03]; p < 0.001) and decreased odds of being discharged to home (OR 0.34 to 0.78 [95% CI 0.29 to 0.86]; p < 0.001). Higher-volume hospitals incur lower costs, shorter lengths of stay, and higher rates of discharge to home than lower-volume hospitals when performing inpatient THA and TKA. These findings suggest that small and medium-sized regional hospitals are disproportionately impacted by declining reimbursement and may necessitate special treatment to remain viable as bundled payment models continue to erode hospital payments. Further research is also warranted to identify the key drivers of this volume-based cost variation, which may facilitate quality improvement initiatives at the hospital and policy levels.

156. Pain location and exacerbating activities associated with treatment success following basivertebral nerve ablation: an aggregated cohort study of multicenter prospective clinical trial data

BACKGROUND CONTEXT Traditionally, researchers and clinicians have assumed that the vast majority of nociceptive signals intrinsic to the spine have been discogenic. Despite this assumption, ample research demonstrates nociceptive innervation of the vertebral endplate by the basivertebral nerve (BVN). Little is known about the clinically relevant pain loci or specific presenting situations that may predispose individuals to treatment success by BVN radiofrequency ablation. PURPOSE This study presents pain location “maps” and investigates the relationship between low back pain (LBP) exacerbating activities and treatment response to basivertebral nerve radiofrequency ablation (BVN RFA) in patients with clinically-suspected vertebral endplate pain (VEP). STUDY DESIGN/SETTING Aggregated cohort study of 296 patients treated with BVN RFA at 33 global centers in three prospective clinical trials. OUTCOME MEASURES Treatment success definitions were: (1) =50% LBP visual analog scale (VAS), (2) =15-point Oswestry Disability Index (ODI), and (3) =50% VASor=15-point ODI improvements from baseline. METHODS Participant demographics, pain diagrams and LBP-exacerbating activities were analyzed using stepwise logistic regression for predictors of treatment success. RESULTS Midline LBP correlated with BVN RFA treatment success in individuals with clinically suspected VEP, though pain in the paraspinal and mid-upper gluteal regions was also present. Duration of pain=5 years (OR 2.366), lack of epidural steroid injection within 6 months (OR 1.799), and LBP exacerbation with physical activity (OR 2.099) and side-bending (OR 2.184) increased odds of treatment success, whereas exacerbation with spinal extension (OR 0.542) and baseline opioid use (OR 0.509) decreased odds of treatment success. Regressions areas under the curve (AUCs) were under 70%, indicative of low predictive value. CONCLUSIONS This study demonstrates that midline LBP correlates with BVN RFA treatment success in individuals with clinically-suspected VEP. None of the models demonstrated strong predictive value, indicating that use of objective imaging biomarkers (Type 1 and/or 2 Modic changes) and a correlating presentation of anterior spinal element pain remain the most useful patient selection factors for BVN RFA. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs. Traditionally, researchers and clinicians have assumed that the vast majority of nociceptive signals intrinsic to the spine have been discogenic. Despite this assumption, ample research demonstrates nociceptive innervation of the vertebral endplate by the basivertebral nerve (BVN). Little is known about the clinically relevant pain loci or specific presenting situations that may predispose individuals to treatment success by BVN radiofrequency ablation. This study presents pain location “maps” and investigates the relationship between low back pain (LBP) exacerbating activities and treatment response to basivertebral nerve radiofrequency ablation (BVN RFA) in patients with clinically-suspected vertebral endplate pain (VEP). Aggregated cohort study of 296 patients treated with BVN RFA at 33 global centers in three prospective clinical trials. Treatment success definitions were: (1) =50% LBP visual analog scale (VAS), (2) =15-point Oswestry Disability Index (ODI), and (3) =50% VASor=15-point ODI improvements from baseline. Participant demographics, pain diagrams and LBP-exacerbating activities were analyzed using stepwise logistic regression for predictors of treatment success. Midline LBP correlated with BVN RFA treatment success in individuals with clinically suspected VEP, though pain in the paraspinal and mid-upper gluteal regions was also present. Duration of pain=5 years (OR 2.366), lack of epidural steroid injection within 6 months (OR 1.799), and LBP exacerbation with physical activity (OR 2.099) and side-bending (OR 2.184) increased odds of treatment success, whereas exacerbation with spinal extension (OR 0.542) and baseline opioid use (OR 0.509) decreased odds of treatment success. Regressions areas under the curve (AUCs) were under 70%, indicative of low predictive value. This study demonstrates that midline LBP correlates with BVN RFA treatment success in individuals with clinically-suspected VEP. None of the models demonstrated strong predictive value, indicating that use of objective imaging biomarkers (Type 1 and/or 2 Modic changes) and a correlating presentation of anterior spinal element pain remain the most useful patient selection factors for BVN RFA.

Present Evidence of Determinants to Predict the Efficacy of Renal Denervation

Sympathetic overactivation is one of the main contributors to development and progress of hypertension. Renal denervation (RDN) has been evidenced by series of clinical trials for its efficacy and safety to treat overactivated sympathetic nervous system induced diseases. However, the results were inconsistent and not all patients benefited from RDN. Appropriate patient selection and intraoperative factors to improve the efficacy of RDN need to be solved urgently. Over the decade, research studies on the correlations between indicators and the antihypertensive effects have been conducted and made a fairly well progress. Herein, we comprehensively reviewed the research studies on how to make RDN more predictable or improve the efficacy of RDN and summarized these potential indicators or devices which might be applied in clinical settings.

Magnetic Resonance Imaging Characteristics Associated with Treatment Success from Basivertebral Nerve Ablation: An Aggregated Cohort Study of Multicenter Prospective Clinical Trials Data.

ObjectiveInvestigate associations between endplate and motion segment magnetic resonance imaging (MRI) characteristics and treatment outcomes following basivertebral nerve radiofrequency ablation (BVN RFA) in patients with clinically suspected vertebral endplate pain (VEP).DesignAggregated cohort study of 296 participants treated with BVN RFA from three prospective clinical trials.MethodsBaseline MRI characteristics were analyzed using stepwise logistic regression to identify factors associated with treatment success. Predictive models used three definitions of treatment success: (1) ≥50% low back pain (LBP) visual analog scale (VAS), (2) ≥15-point Oswestry Disability Index (ODI), and (3) ≥50% VAS or ≥15-point ODI improvements at 3-months post-BVN RFA.ResultsThe presence of lumbar facet joint fluid (odds ratio [OR] 0.586) reduced the odds of BVN RFA treatment success in individuals with clinically suspected VEP. In patients with a less advanced degenerative disc disease (DDD) profile, a > 50% area of the endplate with bone marrow intensity changes (BMIC) was predictive of treatment success (OR 4.689). Both regressions areas under the curve (AUCs) were under 70%, indicating low predictive value. All other vertebral endplate, intervertebral disc, nerve roots facet joint, spinal segmental alignment, neuroforamina, lateral recesses, and central canal MRI characteristics were not associated with BVN RFA success.ConclusionsIn patients with vertebrogenic low back pain with Modic changes, the presence of degenerative findings of the anterior and posterior column was not associated with a clinically important impact on BVN RFA treatment success. None of the models demonstrated strong predictive value, indicating that the use of objective imaging biomarkers (Type 1 and/or 2 Modic changes) and a correlating presentation of pain remain the most useful patient selection factors for BVN RFA.