The Northern New England Rapid Deployment Valve Experience: Survival and Procedural Outcomes From 2015 to 2021.

OBJECTIVE: The optimal approach and choice of initial aortic valve replacement (AVR) is evolving in the growing era of transcatheter AVR. Further survival and hemodynamic data are needed to compare the emerging role of rapid deployment (rdAVR) versus stented (sAVR) valve options for AVR. METHODS: The Northern New England Cardiovascular Database was queried for patients undergoing either isolated AVR or AVR + coronary artery bypass grafting (CABG) with rdAVR or sAVR aortic valves between 2015 and 2021. Exclusion criteria included endocarditis, mechanical valves, dissection, emergency case status, and prior sternotomy. This resulted in a cohort including 1,616 sAVR and 538 rdAVR cases. After propensity weighting, procedural characteristics, hemodynamic variables, and survival outcomes were examined. RESULTS: The breakdown of the overall cohort (2,154) included 1,164 isolated AVR (222 rdAVR, 942 sAVR) and 990 AVR + CABG (316 rdAVR, 674 sAVR). After inverse propensity weighting, cohorts were well matched, notable only for more patients <50 years in the sAVR group (4.0% vs 1.9%, standardized mean difference [SMD] = -0.12). Cross-clamp (89 vs 64 min, SMD = -0.71) and cardiopulmonary bypass (121 vs 91 min, SMD = -0.68) times were considerably longer for sAVR versus rdAVR. Immediate postreplacement aortic gradient decreased with larger valve size but did not differ significantly between comparable sAVR and rdAVR valve sizes or overall (6.5 vs 6.7 mm Hg, SMD = 0.09). Implanted rdAVR tended to be larger with 51% either size L or XL versus 37.4% of sAVR ≥25 mm. Despite a temporal decrease in pacemaker rate within the rdAVR cohort, the overall pacemaker frequency was less in sAVR versus rdAVR (4.4% vs 7.4%, SMD = 0.12), and significantly higher rates were seen in size L (10.3% vs 3.7%, P < 0.002) and XL (15% vs 5.6%, P < 0.004) rdAVR versus sAVR. No significant difference in major adverse cardiac events (4.6% vs 4.6%, SMD = 0.01), 30-day survival (1.5% vs 2.6%, SMD = 0.08), or long-term survival out to 4 years were seen between sAVR and rdAVR. CONCLUSIONS: Rapid deployment valves offer a safe alternative to sAVR with significantly decreased cross-clamp and cardiopulmonary bypass times. Despite larger implantation sizes, we did not appreciate a comparative difference in immediate postoperative gradients, and although pacemaker rates are improving, they remain higher in rdAVR compared with sAVR. Longer-term hemodynamic and survival follow-up are needed.

Why Are We Weighting? Understanding the Estimates From Propensity Score Weighting and Matching Methods.

BACKGROUND: Propensity score methods are used in observational studies to compensate for the lack of random allocation by balancing measured baseline characteristics between treated and untreated patients. We sought to explain the treatment effect estimates derived from different propensity score methods. METHODS: We performed a retrospective analysis of long-term mortality after single internal mammary artery versus bilateral internal mammary artery (BIMA) conduit in 47 984 index isolated coronary artery bypass grafting procedures from 1992 to 2014 in the Northern New England Cardiovascular Disease Study Group registry using multivariable Cox regression, 1:1 propensity score matching, inverse probability weighting (IPW) among the treated, and IPW among the overall population treatment estimates. RESULTS: The mean duration of follow-up was 13.2 (interquartile range, 7.4-17.7) years. In multivariable Cox regression, the adjusted hazard ratio for mortality was 0.83 (95% CI, 0.75-0.92) in patients receiving BIMA compared with a single internal mammary artery. The 1:1 propensity matched (hazard ratio, 0.79 [95% CI, 0.69-0.91]) and IPW among the treated (hazard ratio, 0.83 [95% CI, 0.75-0.92]) estimates showed a protective treatment effect of BIMA use on mortality. However, the IPW estimate of treatment effect for the overall population showed an increased risk of mortality after BIMA that was not statistically significant (hazard ratio, 1.08 [95% CI, 0.94-1.24]). CONCLUSIONS: While the multivariable Cox regression, 1:1 propensity matching, and IPW treatment effect in the treated estimates demonstrate that BIMA was associated with a statistically significantly decreased risk of mortality, the IPW treatment effect in the average study population showed an increased risk of mortality associated with BIMA that was not statistically significant. This is attributed to the different populations (weighted to look like the overall study population versus treated group) represented by the 2 IPW approaches. Determining how the study population is balanced is a large driver of the treatment effect. Ultimately, the treatment effect estimate desired should drive the choice of the propensity score method.

The association of major adverse limb events and combination stent and atherectomy in patients undergoing revascularization for lower extremity peripheral artery disease.

BACKGROUND: The effectiveness of combined atherectomy and stenting relative to use of each procedure alone for the treatment of lower extremity peripheral artery disease has not been evaluated. AIMS: The objective of this study was to evaluate the short- and long-term major adverse limb event (MALE) following the receipt of stenting, atherectomy, and the combination of stent and atherectomy. METHODS: A retrospective cohort of patients undergoing atherectomy, stent, and combination stent atherectomy for lower extremity peripheral artery disease was derived from the Vascular Quality Initiative (VQI) data set. The primary outcome was MALE and was assessed in the short-term and long-term. Short-term MALE was assessed immediately following the procedure to discharge and estimated using logistic regression. Long-term MALE was assessed after discharge to end of follow-up and estimated using the Fine-Gray subdistribution hazard model. RESULTS: Among the 46,108 included patients, 6896 (14.95%) underwent atherectomy alone, 35,774 (77.59%) received a stent, and 3438 (7.5%) underwent a combination of stenting and atherectomy. The adjusted model indicated a significantly higher odds of short-term MALE in the atherectomy group (OR = 1.35; 95% confidence interval [CI]:1.16-1.57), and not significantly different odds (OR = 0.93; 95% CI:0.77-1.13) in the combination stent and atherectomy group when compared to stenting alone. With regard to long-term MALE, the model indicated that the likelihood of experiencing the outcome was slightly lower (HR = 0.90; 95% CI:0.82-0.98) in the atherectomy group, and not significantly different (HR = 0.92; 95% CI:0.82-1.04) in the combination stent and atherectomy group when compared to the stent group. CONCLUSIONS: Patients in the VQI data set who received combination stenting and atherectomy did not experience significantly different rates of MALE when compared with stenting alone. It is crucial to consider and further evaluate the influence of anatomical characteristics on treatment strategies and potential differential effects of comorbidities and other demographic factors on the short and long-term MALE risks.

Therapeutic anticoagulation after index peripheral endovascular intervention in patients with claudication.

OBJECTIVE: Antiplatelet agents are commonly used after peripheral endovascular intervention (PVI). However, the effect of full-dose anticoagulation on outcomes after PVI is not well-established. We sought to investigate whether full-dose anticoagulation after PVI is associated with adverse events. METHODS: We utilized the Vascular Quality Initiative to study patients undergoing index PVI for claudication (2010-2019), stratified by the presence or absence of an anticoagulant on discharge. The primary outcomes were 2-year patency, major adverse limb events (MALE), and mortality. We built a propensity score adjusting for comorbidities and employed inverse probability weighting to estimate the association of anticoagulation with outcomes. RESULTS: We identified 26,240 patients; 9.1% were discharged on an anticoagulant. Patients receiving any anticoagulation had a significantly higher risk of mortality (adjusted hazard ratio [aHR], 1.61; 95% confidence interval [CI], 1.35-1.92), but not MALE, or patency loss. Patients receiving a vitamin K antagonist had a significantly higher risk of patency loss (aHR, 1.32; 95% CI, 1.09-1.60), MALE (aHR, 1.33; 95% CI, 1.13-1.57), and mortality (aHR, 1.46; 95% CI, 1.27-1.69). Patients on an oral Factor Xa inhibitors had a significantly lower risk of patency loss (aHR, 0.61; 95% CI, 0.41-0.93) but increased mortality (aHR, 1.51; 95% CI, 1.19-1.92). CONCLUSIONS: Therapeutic anticoagulation after PVI is associated with higher risk of all-cause mortality. Although oral Factor Xa inhibitors are associated with decreased risk of patency loss, vitamin K antagonists are associated with higher risk of patency loss, MALE, and death. Further prospective studies are necessary to study the safety and efficacy of full-dose anticoagulation after PVI.

Sex differences in outcomes among adults undergoing abdominal aortic aneurysm repair.

OBJECTIVE: Although the differences in short-term outcomes between male and female patients in abdominal aortic aneurysm (AAA) repair have been well studied, it remains unclear if these sex disparities extend to other long-term adverse outcomes after AAA repair, such as reintervention and late rupture. METHODS: We performed a retrospective cohort study of 13,007 patients who underwent either endovascular (EVAR) or open AAA repair (OAR) between 2003 and 2015 using data from the Vascular Quality Initiative registries. Eligible patients were linked to fee-for-service Medicare claims to identify late outcomes of rupture and aneurysm-specific reintervention. RESULTS: The mean age of our cohort was 76 ± 6.7 years, 22% were female, 94% were White, and 77% underwent EVAR. The 10-year rupture incidence was slightly higher for women at 4.8 per 1000 person-years, vs 3.9 for men, but this difference was not statistically significant after risk adjustment (hazard ratio [HR] = 1.13, 95% confidence interval [CI]: 0.74-1.73). Likewise, we found no sex difference in reintervention rates (5.1 vs 4.8 in women per 1000 person-years) even after risk adjustment (HR = 0.95, 95% CI: 0.83-1.09). Regression models suggest effect modification by repair type for reintervention, where women who underwent index EVAR had a higher risk of reintervention than men (HR = 1.08, 95% CI: 0.93-1.26), whereas women who underwent OAR were at a lower risk of reintervention than men (HR = 0.79, 95% CI: 0.58-1.08); however, neither effect reached statistical significance within each subgroup. In addition, we found that the risk of reintervention for women vs men varied by clinical presentation, where women were less likely to undergo reintervention after an elective or symptomatic AAA repair but were more likely to undergo reintervention after a repair for AAA rupture (HR = 1.70, 95% CI: 1.05-2.75). CONCLUSIONS: Male and female patients who underwent AAA repair had similar rates of reintervention and late aneurysm rupture in the 10 years after their procedure. However, our findings suggest that repair type and clinical presentation may affect the role of sex in clinical outcomes and warrant further exploration in these subgroups.

Association of rurality, socioeconomic status, and race with pancreatic cancer surgical treatment and survival.

BACKGROUND: Pancreatectomy is a necessary component of curative intent therapy for pancreatic cancer, and patients living in nonmetropolitan areas may face barriers to accessing timely surgical care. We evaluated the intersecting associations of rurality, socioeconomic status (SES), and race on treatment and outcomes of Medicare beneficiaries with pancreatic cancer. METHODS: We conducted a retrospective cohort study, using fee-for-service Medicare claims of beneficiaries with incident pancreatic cancer (2016-2018). We categorized beneficiary place of residence as metropolitan, micropolitan, or rural. Measures of SES were Medicare-Medicaid dual eligibility and the Area Deprivation Index. Primary study outcomes were receipt of pancreatectomy and 1-year mortality. Exposure-outcome associations were assessed with competing risks and logistic regression. RESULTS: We identified 45 915 beneficiaries with pancreatic cancer, including 78.4%, 10.9%, and 10.7% residing in metropolitan, micropolitan, and rural areas, respectively. In analyses adjusted for age, sex, comorbidity, and metastasis, residents of micropolitan and rural areas were less likely to undergo pancreatectomy (adjusted subdistribution hazard ratio = 0.88 for rural, 95% confidence interval [CI] = 0.81 to 0.95) and had higher 1-year mortality (adjusted odds ratio = 1.25 for rural, 95% CI = 1.17 to 1.33) compared with metropolitan residents. Adjustment for measures of SES attenuated the association of nonmetropolitan residence with mortality, and there was no statistically significant association of rurality with pancreatectomy after adjustment. Black beneficiaries had lower likelihood of pancreatectomy than White, non-Hispanic beneficiaries (subdistribution hazard ratio = 0.80, 95% CI = 0.72 to 0.89, adjusted for SES). One-year mortality in metropolitan areas was higher for Black beneficiaries (adjusted odds ratio = 1.15, 95% CI = 1.05 to 1.26). CONCLUSIONS: Rurality, socioeconomic deprivation, and race have complex interrelationships and are associated with disparities in pancreatic cancer treatment and outcomes.

Association between sex and long-term outcomes of endovascular treatment for peripheral artery disease.

BACKGROUND: Endovascular peripheral vascular intervention (PVI) has become the primary revascularization technique used for peripheral artery disease (PAD). Yet, there is limited understanding of long-term outcomes of PVI among women versus men. In this study, our objective was to investigate sex differences in the long-term outcomes of patients undergoing PVI. METHODS: We performed a cohort study of patients undergoing PVI for PAD from January 1, 2010 to September 30, 2015 using data in the Vascular Quality Initiative (VQI) registry. Patients were linked to fee-for-service Medicare claims to identify late outcomes including major amputation, reintervention, major adverse limb event (major amputation or reintervention [MALE]), and mortality. Sex differences in outcomes were evaluated using cumulative incidence curves, Gray's test, and mixed effects Cox proportional hazards regression accounting for patient and lesion characteristics using inverse probability weighted estimates. RESULTS: In this cohort of 15,437 patients, 44% (n = 6731) were women. Women were less likely to present with claudication than men (45% vs. 49%, p < 0.001, absolute standardized difference, d = 0.08) or be able to ambulate independently (ambulatory: 70% vs. 76%, p < 0.001, d = 0.14). There were no major sex differences in lesion characteristics, except for an increased frequency of tibial artery treatment in men (23% vs. 18% in women, p < 0.001, d = 0.12). Among patients with claudication, women had a higher risk-adjusted rate of major amputation (hazard ratio [HR] = 1.72, 95% confidence interval [CI]: 1.18-2.49), but a lower risk of mortality (HR = 0.86, 95% CI: 0.75-0.99). There were no sex differences in reintervention or MALE for patients with claudication. However, among patients with chronic limb-threatening ischemia, women had a lower risk-adjusted hazard of major amputation (HR = 0.79, 95% CI: 0.67-0.93), MALE (HR = 0.86, 95% CI: 0.78-0.96), and mortality (HR = 0.86, 95% CI: 0.79-0.94). CONCLUSION: There is significant heterogeneity in PVI outcomes among men and women, especially after stratifying by symptom severity. A lower overall mortality in women with claudication was accompanied by a higher risk of major amputation. Men with chronic limb-threatening ischemia had a higher risk of major amputation, MALE, and mortality. Developing sex-specific approaches to PVI that prioritizes limb outcomes in women can improve the quality of vascular care for men and women.

Association of Anticoagulation and Major Adverse Limb Events After Index Peripheral Endovascular Intervention.

Dual-antiplatelet therapy is commonly prescribed after endovascular intervention for peripheral artery disease. However, it is not known whether therapeutic anticoagulation affects outcomes after peripheral endovascular intervention. We sought to investigate whether therapeutic anticoagulation after peripheral endovascular intervention is associated with lower risk of major adverse limb events (MALEs) and all-cause mortality. We studied patients who underwent index endovascular intervention for peripheral artery disease in the Vascular Study Group of New England (2010 to 2018). The main exposure was anticoagulation at the time of discharge. Outcomes included patency loss (occlusion or target lesion reintervention), MALE (any major amputation or reintervention), and all-cause mortality. We compared outcomes between patients who received anticoagulation on discharge versus those who did not receive anticoagulation using Kaplan-Meier survival analysis and Cox regression. In the cohort of 6,809 patients, 15% were discharged on an anticoagulant (mostly warfarin). These patients had a higher prevalence of acute or chronic limb ischemia than those not receiving an anticoagulant (74% vs 47%, p < 0.001) and were less likely to receive any antiplatelet agent after peripheral endovascular intervention (5% vs 14%, p < 0.001). After risk adjustment, compared with patients not on an anticoagulant, patients receiving therapeutic anticoagulation had a higher risk of 2-year patency loss (hazard ratio [HR] 1.41, 95% confidence interval [CI] 1.05 to 1.89), MALE (HR 1.39, 95% CI 1.09 to 1.76), and all-cause mortality (HR 1.24, 95% CI 1.05 to 1.47). In conclusion, anticoagulation after peripheral endovascular intervention was associated with higher risk of adverse events, including patency loss, MALE, and all-cause mortality.

Association of rurality with utilization of palliative care and hospice among Medicare beneficiaries who died from pancreatic cancer: A cohort study.

BACKGROUND: Pancreatic cancer has a 5-year survival of just 10%. Services such as palliative care and hospice are thus crucial in this population, yet their geographic accessibility and utilization remains unknown. AIM: We studied the association between rurality of patient residence and the use of palliative care and hospice. DESIGN, SETTING, AND PARTICIPANTS: Cohort study of continuously enrolled fee-for-service Medicare beneficiaries aged ≥65 diagnosed with incident pancreatic cancer between 04/01/2016-08/31/2018 and who died by 12/31/2018. RESULTS: In this decedent cohort of 31,460 patients, 77% lived in metropolitan areas, 11% in micropolitan areas, 7% in small towns, and 5% in rural areas. Patient demographics were largely similar across rurality; however, the proportion of White, non-Hispanic patients and social deprivation was highest in rural areas and lowest in metropolitan areas. Overall, 33% of patients used any palliative care and 77% received hospice services. After risk adjustment, there were no statistically significant differences in the use of palliative care for patients residing in metropolitan versus micropolitan, small town, or rural areas. Patients in small town (OR = 0.77, 95% CI: 0.69-0.86) and rural areas (OR = 0.75, 95% CI: 0.66-0.85) had lower adjusted odds of receiving hospice care compared to patients in metropolitan areas. CONCLUSIONS: The use of palliative care services captured in Medicare was low, representing either underutilization or failure to accurately measure the extent of services used. While the overall level of hospice enrollment was high, patients in rural communities had relatively lower use of hospice services compared to those in metropolitan areas.

Using a cohort study of diabetes and peripheral artery disease to compare logistic regression and machine learning via random forest modeling.

BACKGROUND: This study illustrates the use of logistic regression and machine learning methods, specifically random forest models, in health services research by analyzing outcomes for a cohort of patients with concomitant peripheral artery disease and diabetes mellitus. METHODS: Cohort study using fee-for-service Medicare beneficiaries in 2015 who were newly diagnosed with peripheral artery disease and diabetes mellitus. Exposure variables include whether patients received preventive measures in the 6 months following their index date: HbA1c test, foot exam, or vascular imaging study. Outcomes include any reintervention, lower extremity amputation, and death. We fit both logistic regression models as well as random forest models. RESULTS: There were 88,898 fee-for-service Medicare beneficiaries diagnosed with peripheral artery disease and diabetes mellitus in our cohort. The rate of preventative treatments in the first six months following diagnosis were 52% (n = 45,971) with foot exams, 43% (n = 38,393) had vascular imaging, and 50% (n = 44,181) had an HbA1c test. The directionality of the influence for all covariates considered matched those results found with the random forest and logistic regression models. The most predictive covariate in each approach differs as determined by the t-statistics from logistic regression and variable importance (VI) in the random forest model. For amputation we see age 85 + (t = 53.17) urban-residing (VI = 83.42), and for death (t = 65.84, VI = 88.76) and reintervention (t = 34.40, VI = 81.22) both models indicate age is most predictive. CONCLUSIONS: The use of random forest models to analyze data and provide predictions for patients holds great potential in identifying modifiable patient-level and health-system factors and cohorts for increased surveillance and intervention to improve outcomes for patients. Random forests are incredibly high performing models with difficult interpretation most ideally suited for times when accurate prediction is most desirable and can be used in tandem with more common approaches to provide a more thorough analysis of observational data.

Association of Rurality, Race and Ethnicity, and Socioeconomic Status With the Surgical Management of Colon Cancer and Postoperative Outcomes Among Medicare Beneficiaries.

Importance: Rural patients with colon cancer experience worse outcomes than urban patients, but the extent to which disparities are explained by social determinants is not known. Objectives: To evaluate the association of rurality with surgical treatment and outcomes of colon cancer and to investigate the intersection of rurality with race and ethnicity and socioeconomic status. Design, Settings, and Participants: This cohort study included fee-for-service Medicare beneficiaries 65 years or older diagnosed with incident, nonmetastatic colon cancer between April 1, 2016, and September 30, 2018, with follow-up until December 31, 2018. Data were analyzed from August 3, 2020, to April 30, 2021. Exposures: Rurality of patient's residence, categorized as metropolitan, micropolitan, or small town or rural, using Rural-Urban Commuting Area codes. Main Outcomes and Measures: Receipt of surgery, emergent surgery, or minimally invasive surgery (MIS); 90-day surgical complications; and 90-day mortality. Results: Among 57 710 Medicare beneficiaries with incident, nonmetastatic colon cancer, 46.6% were men, 53.4% were women, and the mean (SD) age was 76.6 (7.2) years. In terms of race and ethnicity, 3.7% were Hispanic, 6.4% were non-Hispanic Black (hereinafter Black), 86.1% were non-Hispanic White (hereinafter White), and 3.8% were American Indian or Alaska Native, Asian or Pacific Islander, or unknown race or ethnicity. Patients residing in nonmetropolitan areas were more likely to undergo surgical resection than those residing in metropolitan areas (69.2% vs 63.9%; P < .001). Black race was independently associated with lower hazard of surgical resection (hazard ratio, 0.92 [95% CI, 0.88-0.95]). Race and ethnicity and measures of socioeconomic status did not modify the association of rurality with surgery. Beneficiaries from small town and rural areas had higher odds of undergoing emergent surgery (adjusted odds ratio [OR], 1.32 [95% CI, 1.20-1.44]) but lower odds of undergoing MIS (adjusted OR, 0.75 [95% CI, 0.70-0.80]), with similar findings for patients residing in micropolitan areas. Members of racial and ethnic minority groups who resided in small town and rural settings experienced higher odds of postoperative surgical complications (P = .001 for interaction) and mortality (P = .001 for interaction). Notably, White patients who resided in small town and rural areas experienced lower odds of postoperative mortality than their White metropolitan counterparts (adjusted OR, 0.81 [95% CI, 0.71-0.92]), but Black patients who resided in small town and rural areas had significantly higher odds of postoperative mortality (adjusted OR, 1.86 [95% CI, 1.16-2.97]) than their Black metropolitan counterparts. Conclusions and Relevance: These findings suggest that Medicare beneficiaries from small town and rural areas were more likely to undergo surgery for nonmetastatic colon cancer than metropolitan beneficiaries but also more likely to undergo emergent surgery and less likely to have MIS. The experiences of rural patients varied by race; rurality was associated with higher postoperative mortality for Black patients but not for other racial and ethnic groups.

Patient Risk Factors Associated with Reported Urinary Quality of Life Following Artificial Urinary Sphincter Placement: A Paired Pre and Postoperative Analysis.

OBJECTIVE: To evaluate potential associations between patient risk factors and incontinence related patient-reported outcome measures (PROMs) preandpost artificial urinary sphincter (AUS) implantation. We hypothesize patient risk factors, including prior radiation and diabetes will have a negative association with post AUS PROMs. METHODS: A review of prospectively collected preandpostoperative Incontinence Symptom Index [ISI] and Incontinence Impact Questionnaire-7 (IIQ-7)s from multiple institutions in the Trauma and Urologic Reconstruction Network of Surgeons was performed. Changes in preandpost AUS ISI and IIQ-7 scores were compared for the entire cohort then stratified by patients with prior AUS, obesity, diabetes, prior radiation, and mixed urinary incontinence. RESULTS: A total of 145 patients, 67.2 (SD 10.9) years had complete preandpost AUS questionnaires (median follow up 186 days, IQR 136-362). Post AUS ISI and IIQ-7 scores improved significantly for the group at large. Prior radiation was associated with less improvement in total IIQ-7 scores, -25.5 (31.9) vs -39 (33.0), P = .03. Obesity was associated with a greater reduction in incontinence severity -13.6 (SD 9.1) vs -9.2 (SD 8.9), P<0.01, urge -5.2(SD 4.2) vs -2.5(SD 4.5), P <.01, and total ISI score -29.7(SD19.7) vs -21.2 (SD 19.9), P = .02. Prior AUS, diabetes, and mixed incontinence were not associated with post AUS PROMs outcome. CONCLUSION: Overall, patients reported a significant reduction in incontinence severity, bother, impact, and distress following AUS placement. Prior radiation was associated with less improvement in total IIQ-7 scores. In contrast, obesity demonstrated a greater reduction in ISI severity and urge scores compared to non-obese patients.

Surgery Prescription Opioid Misuse and Diversion in US Adults and Associated Risk Factors.

INTRODUCTION: To justify a practice change, it is critical to determine if opioids prescribed after surgery, surgery prescription (Rx) opioids, are in fact associated with opioid misuse and diversion. Currently, there is only limited data to support this assumption. METHODS: We administered a 40-question survey to US adults (18+) who had received a surgery Rx opioid within the last 5 y on Amazon Mechanical Turk, an online crowdsourcing worksite. Incidence and risk factors for surgery Rx opioid misuse, self-reported taking of surgery Rx opioids in a way other than instructed by a provider, and diversion, self-reported having one's surgery Rx opioids shared, sold, or stolen, were analyzed. The government validated Opioid Risk Tool (ORT) was used. RESULTS: A total of 966 participants from all 50 states met inclusion: 52% were male, 43% were aged 30-39 y, and 79% self-identified as white. Overall, 34% (n = 333) of respondents reported misusing their surgery Rx opioids and risk factors included working in healthcare, scoring high on the ORT, experiencing an elevated mood with opioids, refilling a Rx, and keeping leftover pills. A total of 22% (n = 212) reported diverting their surgery Rx opioids, and risk factors included working in healthcare, scoring high on the ORT, undergoing plastic surgery, refilling a Rx, and keeping leftover pills. CONCLUSIONS: Rates of surgery Rx opioid misuse and diversion in the US may be as high as one in three and one in five adults, respectively. Efforts to improve leftover pill disposal and risk stratification for prescribing patterns may help to mitigate risk.

Minimally Invasive Surgery Approach is Not Associated With Differences in Long-Term Bowel Function Patient-Reported Outcomes After Elective Sigmoid Colectomy.

BACKGROUND: Postoperative bowel function is a common concern for patients undergoing a sigmoidectomy. We have previously demonstrated that patients with symptomatic bowel function preoperatively have substantial improvement at long-term follow-up. However, the effect of the operative approach on patient-reported bowel function is largely unknown. We aimed to evaluate the differences in long-term patient-reported bowel function after robotic or laparoscopic sigmoid colectomies for benign and malignant disease. MATERIALS AND METHODS: A retrospective analysis of a prospectively collected institutional database from July 2015 to July 2020. Patients included underwent a sigmoid colectomy for benign or malignant disease and completed the Colorectal Functional Outcome (COREFO) questionnaire at preoperative presentation, postoperatively, and long-term follow-up. Differences between preoperative and postoperative scores, as well as differences between the robotic and laparoscopic cohorts, were compared using paired t-tests. RESULTS: A total of 169 patients met inclusion criteria with a median age of 61 y, and 55% of the patients underwent robotic sigmoid colectomy, with the most common diagnosis being diverticular disease (62%). There was no significant difference between the presentation, short-term, or long-term follow-up total COREFO scores or subdomains based on the surgical technique. Patients that present asymptomatic remain asymptomatic, while those that are symptomatic demonstrate improvements for both the robotic and laparoscopic groups. CONCLUSIONS: Patient-reported long-term global bowel function does not appear to differ between patients who underwent elective robotic or laparoscopic sigmoid colectomy for benign or malignant disease. Patients that present asymptomatic remain asymptomatic, while those that are symptomatic demonstrate improvements, regardless of surgical technique.

Cardiac Surgery Outcomes: A Case for Increased Screening and Treatment of Obstructive Sleep Apnea.

BACKGROUND: Because of the limited published information on complications that obstructive sleep apnea (OSA) patients experience during and after cardiac surgery, we investigated OSA as a risk factor for postoperative outcomes. METHODS: This project used the Northern New England Cardiovascular Disease Study Group's data collected between 2011 and 2017 based on The Society of Thoracic Surgeons Adult Cardiac Surgery Database Data Collections form. A retrospective analysis of 1555 patients with OSA and 10,450 patients without OSA across 5 medical centers undergoing isolated coronary artery bypass grafting, isolated valve surgery, and combined coronary artery bypass grafting valve surgery was conducted. We used 1:1 nearest-neighbor propensity score matching with no replacement to balance characteristics among patients with and without OSA. RESULTS: There was a statistically significant increased risk of postoperative pneumonia, increased length of total and postoperative stay, and time to initial extubation. Two outcomes trended toward significance: intra- and postoperative intraaortic balloon pump use. Outcomes that failed to show statistical significance were surgical site infection, atrial fibrillation, cerebrovascular accident, permanent pacemaker placement, and blood products given. A chart review conducted on a subset of the study cohort revealed that more than 40% of OSA patients did not receive continuous positive airway pressure or bilevel positive airway pressure therapy postoperatively during their hospitalization. CONCLUSIONS: Our study aligns with the literature in concluding that OSA has deleterious effects on postoperative outcomes of cardiac surgery patients. Further research to better stratify OSA patients by severity are still needed. Additionally heightened awareness of the need to screen, diagnose, and properly treat patients for OSA is needed.

Decade Long Temporal Trends in Revascularization for Patients With Diabetes Mellitus (From the Northern New England Cardiovascular Disease Study Group).

The FREEDOM trial demonstrated superiority of coronary artery bypass grafting (CABG) for patients with diabetes mellitus (DM) and multivessel coronary artery disease (MV CAD) as compared to percutaneous coronary intervention (PCI) with drug eluting stent (PCI-DES). We sought to study the impact of the FREEDOM trial on clinical practice. We studied trends in the use of CABG vs. PCI and factors associated with revascularization strategy among 6,985 patients with concomitant CAD and MV CAD at 7 centers pre- and post-trial (2008-2012 vs. 2013-2017) as well as hospital outcomes. Multivariable mixed effects logistic regression was performed to identify risk factors associated with choice of revascularization strategy among the patients with 3-vessel CAD (3V CAD). 41% of patients had 3V CAD and 18% were ≥75 years of age. While PCI-DES was the preferred strategy in 2-vessel CAD (2V CAD), 72% of patients with 3V CAD underwent CABG. For patients with 3V CAD, the ratio of CABG to PCI-DES procedures was 2.47 over the decade and did not differ pre- and post-trial (adjusted odds ratio (OR) for CABG (vs. PCI) 1.01, 95% confidence interval (CI) 0.84-1.20). Independent risk factors of CABG among patients with DM and 3V CAD included peripheral arterial disease and absence of prior myocardial infarction and prior PCI. The risk factors for PCI were female sex (OR 0.60, 95% CI 0.50-0.73, p<0.001) and age ≥75 (OR 0.50, 95% CI 0.35-0.72, p<0.001). Center based variability was observed for CABG vs. PCI (center effect, rho=14%, p<0.001). In conclusion, PCI-DES is the preferred strategy for DM patients with MV CAD. Yet, among those with 3V CAD, CABG was chosen in ¾ of patients with no change in clinical practice related to the publication of the FREEDOM trial.

Adjunct diagnostic strategies in improving diagnostic yields in image-guided biopsies of musculoskeletal neoplasms-A cost-effectiveness analysis.

BACKGROUND: Routine use of adjunct intraprocedural fresh frozen biopsy (FFP) or point-of-care (POC) cytology at the time of image-guided biopsy can improve diagnostic tissue yields for musculoskeletal neoplasms, but these are associated with increased costs. OBJECTIVE: This study aimed to ascertain the most cost-effective adjunctive test for image-guided biopsies of musculoskeletal neoplasms. METHODS: This expected value cost-effectiveness microsimulation compared the payoffs of cost (2020 United States dollars) and effectiveness (quality-adjusted life, in days) on each of the competing strategies. A literature review and institutional data were used to ascertain probabilities, diagnostic yields, utility values, and direct medical costs associated with each strategy. Payer and societal perspectives are presented. One- and two-way sensitivity analyses evaluated model uncertainties. RESULTS: The total cost and effectiveness for each of the strategies were $1248.98, $1414.09, $1980.53, and 80.31, 79.74, 79.69 days for the use of FFP, permanent pathology only, and POC cytology, respectively. The use of FFP dominated the competing strategies. Sensitivity analyses revealed FFP as the most cost-effective across all clinically plausible values. CONCLUSIONS: Adjunct FFP is most cost-effective in improving the diagnostic yield of image-guided biopsies for musculoskeletal neoplasms. These findings are robust to sensitivity analyses using clinically plausible probabilities.

Oncological and Functional Outcomes in Joint-sparing Resections of the Proximal Femur for Malignant Primary Bone Tumors.

BACKGROUND: Joint-sparing resections (JSR) of the proximal femur allow for preservation of the proximal femoral growth plate and native hip joint, but whether this offers fewer complications or better function and longevity of the reconstruction remains unknown. In this study, we compared the functional outcomes of pediatric patients with bone sarcomas undergoing JSR of the proximal femur with intercalary allograft (ICA) reconstruction to those undergoing proximal femoral resections (PFR) with allograft-prosthetic composite (APC) reconstructions. METHODS: We retrospectively reviewed all patients undergoing JSR with ICA reconstruction and PFR with APC reconstructions between 1995 and 2013 at a tertiary pediatric referral center. Primary outcomes included major and minor complications and secondary outcomes included the need for a secondary procedure, presence of local or distant relapse, survival status, and the presence of pain and ambulatory status (limp, assistive device, highest level of function). We assessed differences in outcomes using the Fisher exact and Wilcoxon rank-sum tests. RESULTS: Eight patients underwent a JSR and ICA reconstruction, while 7 patients underwent a PFR with APC reconstruction. Median patient follow-up was 60.4 months (interquartile range: 36.8 to 112.9) Patients undergoing JSR and ICA reconstruction were younger than patients undergoing PFR with APC reconstruction (7.7 vs. 11.7 y, P=0.043); however, we found no other statistically significant differences in patient demographics. There were no statistically significant differences in primary or secondary outcomes between the study groups; however, patients who underwent JSR with ICA had more major complications (62.5% vs. 42.9%, P=0.29) and a lower rate of minor complications (25% vs. 28.6%, P=0.22). CONCLUSION: Treatment of proximal femoral bone sarcomas in pediatric and adolescent patients remains a challenging enterprise. JSR with ICA reconstruction in the proximal femur, when feasible, may provide a similar function and risk of intermediate-term major and minor complications when compared with PFR with APC reconstruction. Further long-term studies are required to determine the impact of the native femoral head retention with respect to revision rates. LEVEL OF EVIDENCE: Level III, retrospective comparative study.

A health insurance claims analysis on the effect of female sex on long-term outcomes after peripheral endovascular interventions for symptomatic peripheral arterial occlusive disease.

OBJECTIVE: Several reports have addressed sex disparities in peripheral arterial occlusive disease (PAOD) treatment with inconclusive or even conflicting results. However, most previous studies have neither been sufficiently stratified nor used matching or weighting methods to address severe confounding. In the present study, we aimed to determine the disparities between sexes after percutaneous endovascular revascularization (ER) for symptomatic PAOD. METHODS: Health insurance claims data from the second-largest insurance fund in Germany, BARMER, were used. A large cohort of patients who had undergone index percutaneous ER of symptomatic PAOD from January 1, 2010 to December 31, 2018 were included in the present study. The study cohort was stratified by the presence of intermittent claudication, ischemic rest pain, and wound healing disorders. Propensity score matching was used to adjust for confounding through differences in age, treated vessel region, comorbidities, and pharmacologic treatment. Sex-related differences regarding cardiovascular event-free survival, amputation-free survival, and overall survival within 5 years of surgery were determined using Kaplan-Meier time-to-event curves, log-rank test, and Cox regression analysis. RESULTS: In the present study, 50,051 patients (47.2% women) were identified and used to compose a matched cohort of 35,232 patients. Among all strata, female patients exhibited lower mortality (hazard ratio [HR], 0.69-0.90), fewer amputations or death (HR, 0.70-0.89), and fewer cardiovascular events or death (HR, 0.78-0.91). The association between female sex and improved long-term outcomes was most pronounced for the patients with intermittent claudication. CONCLUSIONS: In the present propensity score-matched analysis of health insurance claims, we observed superior cardiovascular event-free survival, amputation-free survival, and overall survival during 5 years of follow-up after percutaneous ER in women with symptomatic PAOD. Future studies should address sex disparities in the open surgical treatment of PAOD to illuminate whether the conflicting data from previous reports might have resulted from insufficient stratification of the studies.

Guidelines for Patient-CenteredOpioid Prescribing and Optimal FDA-Compliant Disposal of Excess Pills after Inpatient Operation: Prospective Clinical Trial.

BACKGROUND: To optimize responsible opioid prescribing after inpatient operation, we implemented a clinical trial with the following objectives: prospectively validate patient-centered opioid prescription guidelines and increase the FDA-compliant disposal rate of leftover opioid pills to higher than currently reported rates of 20% to 30%. STUDY DESIGN: We prospectively enrolled 229 patients admitted for 48 hours or longer after elective general, colorectal, urologic, gynecologic, or thoracic operation. At discharge, patients received a prescription for both nonopioid analgesics and opioids based on their opioid usage the day before discharge: if 0 oral morphine milligram equivalents (MME) were used, then five 5-mg oxycodone pill-equivalents were prescribed; if 1 to 29 MME were used, then fifteen 5-mg oxycodone pill-equivalents were prescribed; if 30 or more MME were used, then thirty 5-mg oxycodone pill-equivalents were prescribed. We considered patients' opioid pain medication needs to be satisfied if no opioid refills were obtained. To improve FDA-compliant disposal of leftover pills, we implemented patient education, convenient drop-box, reminder phone call, and questionnaire. RESULTS: Our opioid guideline satisfied 93% (213 of 229) of patients. Satisfaction was significantly higher in lower opioid usage groups (p = 0.001): 99% (99 of 100) in the 0 MME group, 90% (91 of 101) in the 1 to 29 MME group, and 82% (23 of 28) in the 30 or more MME group. Overall, 95% (217 of 229) of patients used nonopioid analgesics. Sixty percent (138 of 229) had leftover pills; 83% (114 of 138) disposed of them using an FDA-compliant method and 51% (58 of 114) used the convenient drop-box. Of 2,604 prescribed pills, only 187 (7%) were kept by patients. CONCLUSIONS: This clinical trial prospectively validated a patient-centered opioid discharge prescription guideline that satisfied 93% of patients. FDA-compliant disposal of excess pills was achieved in 83% of patients with easily actionable interventions.