Long-term use of an ankle-foot orthosis intervention in patients with peripheral artery disease using the integrated promoting action on research implementation in health services (i-PARIHS) framework.

BACKGROUND: Peripheral artery disease (PAD) is a cardiovascular disease that limits patients' walking ability. Persistent ankle-foot orthosis (AFO) use may increase the distance patients can walk as well as physical activity. PURPOSE: The purpose of the study was to determine the implementation and patients' perspectives related to the use or disuse of the AFO intervention six months post-intervention. This study was guided by a semi-structured interview and survey based on the integrated Promoting Action on Research Implementation in Health Services (i-PARIHS) constructs. DESIGN: A convergent mixed methods design was used to evaluate participants' perceptions six months following a three-month AFO intervention. A survey and semi-structured questionnaire based on the i-PARIHS constructs were administered and analyzed. SETTING: Vascular surgery clinic and biomechanics research laboratory. PARTICIPANTS: Patients (N = 7; male, 100%; age, 71.9 ± 0.6.7y; body mass index, 29.0 ± 0.5.5; ankle brachial index 0.50 ± 0.17) with claudication completed the study. INTERVENTIONS: A certified orthotist fit participants with an AFO that was worn for 3 months. MAIN OUTCOME MEASURES: Qualitative analysis of semi-structured interviews and quantitative analysis of the survey. RESULTS: The highest positive ratings were seen in the dimensions of usability and cost-effectiveness. The patients found the AFO device and instructions to wear, easy when starting the intervention and there were no out-of-pocket costs. The lower scores and challenges faced with observability and relative advantage domains indicated issues related to motivation for sustained use of the AFO. CONCLUSIONS: Barriers associated with AFO function that prevent common activities and poor health seem to be the biggest issue for not wanting to wear the AFO after the 3-month intervention. Addressing patients' perceptions and challenges to wearing the AFO is essential to increasing compliance and physical activity. Future research should concentrate on understanding the compatibility of orthotic device interventions with the subject's lifestyle. CLINICAL TRIAL REGISTRATION NO: NCT02902211.

Effect of a Decision Aid on Agreement Between Patient Preferences and Repair Type for Abdominal Aortic Aneurysm: A Randomized Clinical Trial.

Importance: Patients with abdominal aortic aneurysm (AAA) can choose open repair or endovascular repair (EVAR). While EVAR is less invasive, it requires lifelong surveillance and more frequent aneurysm-related reinterventions than open repair. A decision aid may help patients receive their preferred type of AAA repair. Objective: To determine the effect of a decision aid on agreement between patient preference for AAA repair type and the repair type they receive. Design, Setting, and Participants: In this cluster randomized trial, 235 patients were randomized at 22 VA vascular surgery clinics. All patients had AAAs greater than 5.0 cm in diameter and were candidates for both open repair and EVAR. Data were collected from August 2017 to December 2020, and data were analyzed from December 2020 to June 2021. Interventions: Presurgical consultation using a decision aid vs usual care. Main Outcomes and Measures: The primary outcome was the proportion of patients who had agreement between their preference and their repair type, measured using χ2 analyses, κ statistics, and adjusted odds ratios. Results: Of 235 included patients, 234 (99.6%) were male, and the mean (SD) age was 73 (5.9) years. A total of 126 patients were enrolled in the decision aid group, and 109 were enrolled in the control group. Within 2 years after enrollment, 192 (81.7%) underwent repair. Patients were similar between the decision aid and control groups by age, sex, aneurysm size, iliac artery involvement, and Charlson Comorbidity Index score. Patients preferred EVAR over open repair in both groups (96 of 122 [79%] in the decision aid group; 81 of 106 [76%] in the control group; P = .60). Patients in the decision aid group were more likely to receive their preferred repair type than patients in the control group (95% agreement [93 of 98] vs 86% agreement [81 of 94]; P = .03), and κ statistics were higher in the decision aid group (κ = 0.78; 95% CI, 0.60-0.95) compared with the control group (κ = 0.53; 95% CI, 0.32-0.74). Adjusted models confirmed this association (odds ratio of agreement in the decision aid group relative to control group, 2.93; 95% CI, 1.10-7.70). Conclusions and Relevance: Patients exposed to a decision aid were more likely to receive their preferred AAA repair type, suggesting that decision aids can help better align patient preferences and treatments in major cardiovascular procedures. Trial Registration: ClinicalTrials.gov Identifier: NCT03115346.

Claudicating patients with peripheral artery disease have meaningful improvement in walking speed after supervised exercise therapy.

OBJECTIVE: Supervised exercise therapy (SET) is a first-line treatment for patients with peripheral artery disease (PAD). The efficacy of SET is most commonly expressed by significant statistical improvement of parameters that do not clarify how each individual patient will benefit from SET. This study examined the minimal clinically important difference (MCID) in walking speed in claudicating patients with PAD after SET. METHODS: A total of 63 patients with PAD-related claudication (Fontaine stage II PAD) participated in a 6-month SET program. Self-selected walking speed was measured before and after SET. Distribution and anchor-based approaches were used to estimate the MCID for small and substantial improvement. The ability to walk one block and the ability to climb one flight of stairs questions were chosen as anchor questions from the Medical Outcomes Study 36-item Short Form questionnaire. Receiver operating characteristics curve analyses were performed to detect the threshold for MCID in walking speed after treatment. RESULTS: The distribution-based method estimated 0.03 m/s as a small improvement and 0.08 m/s as a substantial improvement after SET. Small and substantial improvements according to the anchor question walking one block were 0.05 m/s and 0.15 m/s, respectively. For the climbing one flight of stairs anchor question, 0.10 m/s was a small improvement. Receiver operating characteristics curve analyses identified an increase of 0.04 m/s and 0.03 m/s for improvement based on walking one block and climbing one flight of stairs, respectively. CONCLUSIONS: We report our findings for the MCID for walking speed among claudicating patients receiving SET. Claudicating patients who increase walking speed of 0.03 m/s or greater are more likely to experience a meaningful improvement in walking impairment than those who do not. The MCID reported in this study can serve as a benchmark for clinicians to develop goals and interpret clinically meaningful progress in the care of claudicating patients with PAD.

Considerations for Implementation of an Ankle-Foot Orthosis to Improve Mobility in Peripheral Artery Disease.

OBJECTIVE: To explore the perceptions of wearing an ankle-foot orthosis (AFO) in patients with peripheral artery disease (PAD) who did and did not adopt the AFO intervention. This follows a clinical trial of the effectiveness of an AFO in improving walking distances for patients with PAD-related claudication. DESIGN: A randomized crossover trial of standard of care and an AFO for 3 months. Semistructured interviews were conducted 1.5 months into the AFO intervention to understand acceptability, demand, implementation, and practicality. Data were analyzed using a summative content analysis approach. SETTING: Vascular surgery clinic and biomechanics research laboratory. PARTICIPANTS: Patients (N=15; male, 100%; age, 71.9±.6.7y; body mass index [calculated as weight in kilograms divided by height in meters squared], 29.0±.5.5; ankle brachial index: AFO intervention withdrawal, 0.543; AFO intervention completion, 0.740) with claudication completed the study, and 6 withdrew prior to intervention completion. INTERVENTIONS: A certified orthotist fit participants with an AFO that was worn for 3 months. MAIN OUTCOME MEASURES: Qualitative analysis of the semistructured interviews. RESULTS: Key differences were reported between AFO intervention completion and AFO intervention withdrawal. Six of 14 of AFO intervention completion participants described their initial reactions to the AFO as negative vs 3 of 6 AFO intervention withdrawal participants. Only 5 of 15 AFO intervention completion participants reported minimal use of the AFO compared with 5 of 6 AFO intervention withdrawal participants. The AFO intervention withdrawal group reported higher levels of physical discomfort with the use of the AFO (4/6 vs 7/15) and preexisting health issues becoming a barrier to the use of the AFO (3/6 vs 5/15). Positive aspects reported included ease in standing and walking for AFO intervention withdrawal (4/6) and AFO intervention completion groups (13/15) as well as walking straighter and longer with less pain for AFO intervention withdrawal (3/6) and AFO intervention completion groups (9/15). CONCLUSIONS: Patients withdrawing prior to completion of AFO intervention tended to have more negative perceptions, more comorbidities, and more physical discomfort than those completing the intervention. Both groups reported positive aspects of the AFO. Implementation studies are needed to address barriers to AFO adoption.

Clinical Utility of the Risk Analysis Index as a Prospective Frailty Screening Tool within a Multi-practice, Multi-hospital Integrated Healthcare System.

OBJECTIVE: The goal of this project was to first address barriers to implementation of the Risk Analysis Index (RAI) within a large, multi-hospital, integrated healthcare delivery system, and to subsequently demonstrate its utility for identifying at-risk surgical patients. BACKGROUND: Prior studies demonstrate the validity of the RAI for evaluating preoperative frailty, but they have not demonstrated the feasibility of its implementation within routine clinical practice. METHODS: Implementation of the RAI as a frailty screening instrument began as a quality improvement initiative at the University of Pittsburgh Medical Center in July 2016. RAI scores were collected within a REDCap survey instrument integrated into the outpatient electronic health record and then linked to information from additional clinical datasets. NSQIP-eligible procedures were queried within 90 days following the RAI, and the association between RAI and postoperative mortality was evaluated using logistic regression and Cox proportional hazards models. Secondary outcomes such as inpatient length of stay and readmissions were also assessed. RESULTS: RAI assessments were completed on 36,261 unique patients presenting to surgical clinics across five hospitals from July 1 to December 31, 2016, and 8,172 of these underwent NSQIP-eligible surgical procedures. The mean RAI score was 23.6 (SD 11.2), the overall 30-day and 180-day mortality after surgery was 0.7% and 2.6%, respectively, and the median time required to collect the RAI was 33 [IQR 23-53] seconds. Overall clinic compliance with the recommendation for RAI assessment increased from 58% in the first month of the study period to 84% in the sixth and final month. RAI score was significantly associated with risk of death (HR=1.099 [95% C.I.: 1.091 - 1.106], p < 0.001). At an RAI cutoff of ≥37, the positive predictive values for 30- and 90-day readmission were 14.8% and 26.2%, respectively, and negative predictive values were 91.6% and 86.4%, respectively. CONCLUSIONS: The RAI frailty screening tool can be efficiently implemented within multi-specialty, multi-hospital healthcare systems. In the context of our findings and given the value of the RAI in predicting adverse postoperative outcomes, health systems should consider implementing frailty screening within surgical clinics.

Frailty as measured by the Risk Analysis Index is associated with long-term death after carotid endarterectomy.

OBJECTIVE: The role of carotid endarterectomy (CEA) continues to be debated in the age of optimal medical therapy, particularly for patients with limited life expectancy. The Risk Analysis Index (RAI) measures frailty, a syndrome of decreased physiologic reserve, which increases vulnerability to adverse outcomes. The RAI better predicts surgical complications, nonhome discharge, and death than age or comorbidities alone. We sought to measure the association of frailty, as measured by the RAI, with postoperative in-hospital stroke, long-term stroke, and long-term survival after CEA. We also sought to determine how postoperative stroke interacts with frailty to alter survival trajectory after CEA. METHODS: We queried the Vascular Quality Initiative CEA procedure and long-term data sets (2003-2017) for elective CEAs with complete RAI case information. For all analyses, the cohort was divided into asymptomatic and symptomatic carotid stenosis. Scoring was defined as not frail (RAI <30), frail (RAI 30-34), and very frail (RAI ≥35). Mortality information through December 2017 was obtained from the Social Security Death Index. Multivariable models (logistic and Cox proportional hazards regressions) were used to study the association of frail and very frail patients with the outcomes of interest. In a post hoc analysis, we created Kaplan-Meier curves to analyze patient mortality after CEA as well as after postoperative stroke. RESULTS: Of the 42,869 included patients, 17,092 (39.9%) were female, and 38,395 (89.6%) were white. There were 25,673 (59.9%) patients assigned to the asymptomatic stenosis group and 17,196 (40.1%) patients in the symptomatic stenosis group. Frailty was not associated with perioperative or long-term postoperative stroke. The risk of long-term mortality was significantly higher for frail (hazard ratio, 1.9 [1.7-2.3]) and very frail (hazard ratio, 3.1 [2.6-3.7]) asymptomatic patients; symptomatic frail and very frail patients also had a two to three times increased risk of long-term mortality. Frail and very frail patients had two to three times the risk for long-term mortality compared with patients who were not frail. Postoperative stroke negatively affected the mortality trajectory for all patients in the cohort, regardless of frailty status. CONCLUSIONS: RAI score is not associated with postoperative stroke; however, frail and very frail status is associated with decreased long-term survival in an incremental fashion based on increasing RAI. RAI assessment should be considered in the preoperative decision-making for patients undergoing CEA to ensure long-term survival and optimal surgical outcomes vs medical management.

Assessment of the Risk Analysis Index for Prediction of Mortality, Major Complications, and Length of Stay in Patients who Underwent Vascular Surgery.

BACKGROUND: Frailty is a risk factor for adverse postoperative outcomes. We aimed to test the performance of a prospectively validated frailty measure, the Risk Analysis Index (RAI) in patients who underwent vascular surgery and delineate the additive impact of procedure complexity on surgical outcomes. METHODS: We queried the 2007-2013 American College of Surgeons National Surgical Quality Improvement Program database to identify 6 major elective vascular procedure categories (carotid revascularization, abdominal aortic aneurysm [AAA] repair, suprainguinal revascularization, infrainguinal revascularization, thoracic aortic aneurysm [TAA] repair, and thoracoabdominal aortic aneurysm [TAAA] repair). We trained and tested logistic regression models for 30-day mortality, major complications, and prolonged length of stay (LOS). The first model, "RAI," used the RAI alone; "RAI-Procedure (RAI-P)" included procedure category (e.g., AAA repair) and procedure approach (e.g., endovascular); "RAI-Procedure Complexity (RAI-PC)" added outpatient versus inpatient surgery, general anesthesia use, work relative value units (RVUs), and operative time. RESULTS: The RAI model was a good predictor of mortality for vascular procedures overall (C-statistic: 0.72). The C-statistic increased with the RAI-P (0.78), which further improved minimally, with the RAI-PC (0.79). When stratified by procedure category, the RAI predicted mortality well for infrainguinal (0.79) and suprainguinal (0.74) procedures, moderately well for AAA repairs (0.69) and carotid revascularizations (0.70), and poorly for TAAs (0.62) and TAAAs (0.54). For carotid, infrainguinal, and suprainguinal procedures, procedure complexity (RAI-PC) had little impact on model discrimination for mortality, did improve discrimination for AAAs (0.84), TAAs (0.73), and TAAAs (0.80). Although the RAI model was not a good predictor for major complications or LOS, discrimination improved for both with the RAI-PC model. CONCLUSIONS: Frailty as measured by the RAI was a good predictor of mortality overall after vascular surgery procedures. Although the RAI was not a strong predictor of major complications or prolonged LOS, the models improved with the addition of procedure characteristics like procedure category and approach.

Palliative Care and End-of-Life Outcomes Following High-risk Surgery.

Importance: Palliative care has the potential to improve care for patients and families undergoing high-risk surgery. Objective: To characterize the use of perioperative palliative care and its association with family-reported end-of-life experiences of patients who died within 90 days of a high-risk surgical operation. Design, Setting, and Participants: This secondary analysis of administrative data from a retrospective cross-sectional patient cohort was conducted in the Department of Veterans Affairs (VA) Healthcare System. Patients who underwent any of 227 high-risk operations between January 1, 2012, and December 31, 2015, were included. Exposures: Palliative-care consultation within 30 days before or 90 days after surgery. Main Outcomes and Measures: The outcomes were family-reported ratings of overall care, communication, and support in the patient's last month of life. The VA surveyed all families of inpatient decedents using the Bereaved Family Survey, a valid and reliable tool that measures patient and family-centered end-of-life outcomes. Results: A total of 95 204 patients underwent high-risk operations in 129 inpatient VA Medical Centers. Most patients were 65 years or older (69 278 [72.8%]), and the most common procedures were cardiothoracic (31 157 [32.7%]) or vascular (23 517 [24.7%]). The 90-day mortality rate was 6.0% (5740 patients) and varied by surgical subspecialty (ranging from 278 of 7226 [3.8%] in urologic surgery to 875 of 6223 patients [14.1%] in neurosurgery). A multivariate mixed model revealed that families of decedents who received palliative care were 47% more likely to rate overall care in the last month of life as excellent than those who did not (odds ratio [OR], 1.47 [95% CI, 1.14-1.88]; P = .007), after adjusting for patient's characteristics, surgical subspecialty of the high-risk operation, and survey nonresponse. Similarly, families of decedents who received palliative care were more likely to rate end-of-life communication (OR, 1.43 [95% CI, 1.09-1.87]; P = .004) and support (OR, 1.31 [95% CI, 1.01-1.71]; P = .05) components of medical care as excellent. Of the entire cohort, 3374 patients (3.75%) had a palliative care consultation, and 770 patients (0.8%) received it before surgery. Of all decedents, 1632 (29.9%) had a palliative care consultation, with 319 (5.6%) receiving it before surgery. Conclusions and Relevance: Receipt of a palliative consultation was associated with better ratings of overall end-of-life care, communication, and support, as reported by families of patients who died within 90 days of high-risk surgery. Yet only one-third of decedents was exposed to palliative care. Expanding integration of perioperative palliative care may benefit patients undergoing high-risk operations and their families.

Recalibration and External Validation of the Risk Analysis Index: A Surgical Frailty Assessment Tool.

OBJECTIVE AND BACKGROUND: The Risk Analysis Index (RAI) predicts 30-, 180-, and 365-day mortality based on variables constitutive of frailty. Initially validated, in a single-center Veteran hospital, we sought to improve model performance by recalibrating the RAI in a large, veteran surgical registry, and to externally validate it in both a national surgical registry and a cohort of surgical patients for whom RAI was measured prospectively before surgery. METHODS: The RAI was recalibrated among development and confirmation samples within the Veterans Affairs Surgical Quality Improvement Program (VASQIP; 2010-2014; N = 480,731) including major, elective noncardiac surgery patients to create the revised RAI (RAI-rev), comparing discrimination and calibration. The model was tested externally in the American College of Surgeons National Surgical Quality Improvement Program dataset (NSQIP; 2005-2014; N = 1,391,785), and in a prospectively collected cohort from the Nebraska Western Iowa Health Care System VA (NWIHCS; N = 6,856). RESULTS: Recalibrating the RAI significantly improved discrimination for 30-day [c = 0.84-0.86], 180-day [c = 0.81-0.84], and 365-day mortality [c = 0.78-0.82] (P < 0.001 for all) in VASQIP. The RAI-rev also had markedly better calibration (median absolute difference between observed and predicted 180-day mortality: decreased from 8.45% to 1.23%). RAI-rev was highly predictive of 30-day mortality (c = 0.87) in external validation with excellent calibration (median absolute difference between observed and predicted 30-day mortality: 0.6%). The discrimination was highly robust in men (c = 0.85) and women (c = 0.89). Discrimination also improved in the prospectively measured cohort from NWIHCS for 180-day mortality [c = 0.77 to 0.80] (P < 0.001). CONCLUSIONS: The RAI-rev has improved discrimination and calibration as a frailty-screening tool in surgical patients. It has robust external validity in men and women across a wide range of surgical settings and available for immediate implementation for risk assessment and counseling in preoperative patients.

Supervised walking exercise therapy improves gait biomechanics in patients with peripheral artery disease.

OBJECTIVE: In patients with peripheral artery disease (PAD), supervised exercise therapy is a first line of treatment because it increases maximum walking distances comparable with surgical revascularization therapy. Little is known regarding gait biomechanics after supervised exercise therapy. This study characterized the effects of supervised exercise therapy on gait biomechanics and walking distances in claudicating patients with PAD. METHODS: Forty-seven claudicating patients with PAD underwent gait analysis before and immediately after 6 months of supervised exercise therapy. Exercise sessions consisted of a 5-minute warmup of mild walking and stretching of upper and lower leg muscles, 50 minutes of intermittent treadmill walking, and 5 minutes of cooldown (similar to warmup) three times per week. Measurements included self-perceived ambulatory limitations measured by questionnaire, the ankle-brachial index (ABI), walking distance measures, maximal plantar flexor strength measured by isometric dynamometry, and overground gait biomechanics trials performed before and after the onset of claudication pain. Paired t-tests were used to test for differences in quality of life, walking distances, ABI, and maximal strength. A two-factor repeated measures analysis of variance determined differences for intervention and condition for gait biomechanics dependent variables. RESULTS: After supervised exercise therapy, quality of life, walking distances, and maximal plantar flexor strength improved, although the ABI did not significantly change. Several gait biomechanics parameters improved after the intervention, including torque and power generation at the ankle and hip. Similar to previous studies, the onset of claudication pain led to a worsening gait or a gait that was less like healthy individuals with a pain-free gait. CONCLUSIONS: Six months of supervised exercise therapy produced increases in walking distances and quality of life that are consistent with concurrent improvements in muscle strength and gait biomechanics. These improvements occurred even though the ABI did not improve. Future work should examine the benefits of supervised exercise therapy used in combination with other available treatments for PAD.

Association of Preoperative Patient Frailty and Operative Stress With Postoperative Mortality.

Importance: Patients with frailty have higher risk for postoperative mortality and complications; however, most research has focused on small groups of high-risk procedures. The associations among frailty, operative stress, and mortality are poorly understood. Objective: To assess the association between frailty and mortality at varying levels of operative stress as measured by the Operative Stress Score, a novel measure created for this study. Design, Setting, and Participants: This retrospective cohort study included veterans in the Veterans Administration Surgical Quality Improvement Program from April 1, 2010, through March 31, 2014, who underwent a noncardiac surgical procedure at Veterans Health Administration Hospitals and had information available on vital status (whether the patient was alive or deceased) at 1 year postoperatively. A Delphi consensus method was used to stratify surgical procedures into 5 categories of physiologic stress. Exposures: Frailty as measured by the Risk Analysis Index and operative stress as measured by the Operative Stress Score. Main Outcomes and Measures: Postoperative mortality at 30, 90, and 180 days. Results: Of 432 828 unique patients (401 453 males [92.8%]; mean (SD) age, 61.0 [12.9] years), 36 579 (8.5%) were frail and 9113 (2.1%) were very frail. The 30-day mortality rate among patients who were frail and underwent the lowest-stress surgical procedures (eg, cystoscopy) was 1.55% (95% CI, 1.20%-1.97%) and among patients with frailty who underwent the moderate-stress surgical procedures (eg, laparoscopic cholecystectomy) was 5.13% (95% CI, 4.79%-5.48%); these rates exceeded the 1% mortality rate often used to define high-risk surgery. Among patients who were very frail, 30-day mortality rates were higher after the lowest-stress surgical procedures (10.34%; 95% CI, 7.73%-13.48%) and after the moderate-stress surgical procedures (18.74%; 95% CI, 17.72%-19.80%). For patients who were frail and very frail, mortality continued to increase at 90 and 180 days, reaching 43.00% (95% CI, 41.69%-44.32%) for very frail patients at 180 days after moderate-stress surgical procedures. Conclusions and Relevance: We developed a novel operative stress score to quantify physiologic stress for surgical procedures. Patients who were frail and very frail had high rates of postoperative mortality across all levels of the Operative Stress Score. These findings suggest that frailty screening should be applied universally because low- and moderate-stress procedures may be high risk among patients who are frail.

Association of Frailty and Postoperative Complications With Unplanned Readmissions After Elective Outpatient Surgery.

Importance: Ambulatory surgery in geriatric populations is increasingly prevalent. Prior studies have demonstrated the association between frailty and readmissions in the inpatient setting. However, few data exist regarding the association between frailty and readmissions after outpatient procedures. Objective: To examine the association between frailty and 30-day unplanned readmissions after elective outpatient surgical procedures as well as the potential mediation of surgical complications. Design, Setting, and Participants: In this retrospective cohort study of elective outpatient procedures from 2012 and 2013 in the National Surgical Quality Improvement Program (NSQIP) database, 417 840 patients who underwent elective outpatient procedures were stratified into cohorts of individuals with a length of stay (LOS) of 0 days (LOS = 0) and those with a LOS of 1 or more days (LOS ≥ 1). Statistical analysis was performed from June 1, 2018, to March 31, 2019. Exposure: Frailty, as measured by the Risk Analysis Index. Main Outcomes and Measures: The main outcome was 30-day unplanned readmission. Results: Of the 417 840 patients in this study, 59.2% were women and unplanned readmission occurred in 2.3% of the cohort overall (LOS = 0, 2.0%; LOS ≥ 1, 3.4%). Frail patients (mean [SD] age, 64.9 [15.5] years) were more likely than nonfrail patients (mean [SD] age, 35.0 [15.8] years) to have an unplanned readmission in both LOS cohorts (LOS = 0, 8.3% vs 1.9%; LOS ≥ 1, 8.5% vs 3.2%; P < .001). Frail patients were also more likely than nonfrail patients to experience complications in both cohorts (LOS = 0, 6.9% vs 2.5%; LOS ≥ 1, 9.8% vs 4.6%; P < .001). In multivariate analysis, frailty doubled the risk of unplanned readmission (LOS = 0: adjusted relative risk [RR], 2.1; 95% CI, 2.0-2.3; LOS ≥ 1: adjusted RR, 1.8; 95% CI, 1.6-2.1). Complications occurred in 3.1% of the entire cohort, and frailty was associated with increased risk of complications (unadjusted RR, 2.6; 95% CI, 2.4-2.8). Mediation analysis confirmed that complications are a significant mediator in the association between frailty and readmissions; however, it also indicated that the association of frailty with readmission was only partially mediated by complications (LOS = 0, 22.8%; LOS ≥ 1, 29.3%). Conclusions and Relevance: These findings suggest that frailty is a significant risk factor for unplanned readmission after elective outpatient surgery both independently and when partially mediated through increased complications. Screening for frailty might inform the development of interventions to decrease unplanned readmissions, including those for outpatient procedures.

Risk Prediction Tools to Improve Patient Selection for Carotid Endarterectomy Among Patients With Asymptomatic Carotid Stenosis.

Importance: Randomized clinical trials have demonstrated that patients with asymptomatic carotid stenosis are eligible for carotid endarterectomy (CEA) if the 30-day surgical complication rate is less than 3% and the patient's life expectancy is at least 5 years. Objective: To develop a risk prediction tool to improve patient selection for CEA among patients with asymptomatic carotid stenosis. Design, Setting, and Participants: In this cohort study, veterans 65 years and older who received both carotid imaging and CEA in the Veterans Administration between January 1, 2005, and December 31, 2009 (n = 2325) were followed up for 5 years. Data were analyzed from January 2005 to December 2015. A risk prediction tool (the Carotid Mortality Index [CMI]) based on 23 candidate variables identified in the literature was developed using Veterans Administration and Medicare data. A simpler model based on the number of 4 key comorbidities that were prevalent and strongly associated with 5-year mortality was also developed (any cancer in the past 5 years, chronic obstructive pulmonary disease, congestive heart failure, and chronic kidney disease [the 4C model]). Model performance was assessed using measures of discrimination (eg, area under the curve [AUC]) and calibration. Internal validation was performed by correcting for optimism using 500 bootstrapped samples. Main Outcome and Measure: Five-year mortality. Results: Among 2325 veterans, the mean (SD) age was 73.74 (5.92) years. The cohort was predominantly male (98.8%) and of white race/ethnicity (94.4%). Overall, 29.5% (n = 687) of patients died within 5 years of CEA. On the basis of a backward selection algorithm, 9 patient characteristics were selected (age, chronic kidney disease, diabetes, chronic obstructive pulmonary disease, any cancer diagnosis in the past 5 years, congestive heart failure, atrial fibrillation, remote stroke or transient ischemic attack, and body mass index) for the final logistic model, which yielded an optimism-corrected AUC of 0.687 for the CMI. The 4C model had slightly worse discrimination (AUC, 0.657) compared with the CMI model; however, the calibration curve was similar to the full model in most of the range of predicted probabilities. Conclusions and Relevance: According to results of this study, use of the CMI or the simpler 4C model may improve patient selection for CEA among patients with asymptomatic carotid stenosis.

Association of Frailty With Failure to Rescue After Low-Risk and High-Risk Inpatient Surgery.

Importance: Failure to rescue (FTR), or death after a potentially preventable complication, is a nationally endorsed, publicly reported quality measure. However, little is known about the impact of frailty on FTR, in particular after low-risk surgical procedures. Objective: To assess the association of frailty with FTR in patients undergoing inpatient surgery. Design, Setting, and Participants: This study assessed a cohort of 984 550 patients undergoing inpatient general, vascular, thoracic, cardiac, and orthopedic surgery in the National Surgical Quality Improvement Program between January 1, 2005, and December 31, 2012. Frailty was assessed using the Risk Analysis Index (RAI), and patients were stratified into 5 groups (RAI score, ≤10, 11-20, 21-30, 31-40, and >40). Procedures were categorized as low mortality risk (≤1%) or high mortality risk (>1%). The association between RAI scores, the number of postoperative complications (0, 1, 2, or 3 or more), and FTR was evaluated using hierarchical modeling. Main Outcomes and Measures: The number of postoperative complications and inpatient FTR. Results: A total of 984 550 patients were included, with a mean (SD) age of 58.2 (17.1) years; women were 549 281 (55.8%) of the cohort. For patients with RAI scores of 10 or less, major complication rates after low-risk surgery were 3.2%; rates of those with RAI scores of 11 to 20, 21 to 30, 31 to 40, and more than 40 were 8.6%, 13.5%, 23.8%, and 36.4%, respectively. After high-risk surgery, these rates were 13.5% for those with scores of 10 or less, 23.7% for those with scores of 11 to 20, 31.1% for those with scores of 21 to 30, 42.5% for those with scores of 31 to 40, and 54.4% for those with scores of more than 40. Stratifying by the number of complications, significant increases in FTR were observed across RAI categories after both low-risk and high-risk procedures. After a low-risk procedure, odds of FTR after 1 major complication for patients with RAI scores of 11 to 20 increased 5-fold over those with RAI scores of 10 or less (odds ratio [OR], 5.3; 95% CI, 3.9-7.1). Odds ratios were 8.1 (95% CI, 5.6-11.7) for patients with RAI scores of 21 to 30; 22.3 (95% CI, 13.9-35.6) for patients with scores of 31 to 40; and 43.9 (95% CI, 19-101.1) for patients with scores of more than 40. For patients undergoing a high-risk procedure, the corresponding ORs were likewise consistently elevated (RAI score 11-20: OR, 2.5; 95% CI, 2.3-2.7; vs RAI score 21-30: 5.1; 95% CI, 4.6-5.5; vs RAI score 31-40: 8.9; 95% CI, 8.1-9.9; vs RAI score >40: 18.4; 95% CI, 15.7-21.4). Conclusions and Relevance: Frailty has a dose-response association with complications and FTR, which is apparent after low-risk and high-risk inpatient surgery. Systematic assessment of frailty in preoperative patients may help refine estimates of surgical risk that could identify patients who might benefit from perioperative interventions designed to enhance physiologic reserve and potentially mitigate aspects of procedural risk, and would provide a framework for shared decision-making regarding the value of a given surgical procedure.

Muscle strength and control characteristics are altered by peripheral artery disease.

OBJECTIVE: Peripheral artery disease (PAD), a common manifestation of atherosclerosis, is characterized by lower leg ischemia and myopathy in association with leg dysfunction. Patients with PAD have impaired gait from the first step they take with consistent defects in the movement around the ankle joint, especially in plantar flexion. Our goal was to develop muscle strength profiles to better understand the problems in motor control responsible for the walking impairment in patients with PAD. METHODS: Ninety-four claudicating PAD patients performed maximal isometric plantar flexion contractions lasting 10 seconds in two conditions: pain free (patient is well rested and has no claudication symptoms) and pain induced (patient has walked and has claudication symptoms). Sixteen matched healthy controls performed the pain-free condition only. Torque curves were analyzed for dependent variables of muscle strength and motor control. Independent t-tests were used to compare variables between groups, and dependent t-tests determined differences between conditions. RESULTS: Patients with PAD had significantly reduced peak torque and area under the curve compared with controls. Measures of control differed between PAD conditions only. Load rate and linear region duration were greater in the pain condition. Time to peak torque was shorter in the pain condition. CONCLUSIONS: This study conclusively demonstrates that the plantar flexor muscles of the PAD patient at baseline and without pain are weaker in patients with PAD compared with controls. With the onset of claudication pain, patients with PAD exhibit altered muscle control strategies and further strength deficits are manifest compared to baseline levels. The myopathy of PAD legs appears to have a central role in the functional deterioration of the calf muscles, as it is evident both before and after onset of ischemic pain.

Contained Rupture of an Abdominal Aortic Aneurysm With Extensive Vertebral Body and Retroperitoneal Space Destruction.

Chronic contained rupture of an abdominal aortic aneurysm with vertebral body erosion most commonly presents with symptoms of low back pain. Although not well known, vertebral body erosion or destruction may be seen in up to 25% of patients with sealed or contained rupture of an abdominal aortic aneurysm. This appearance on cross-sectional imaging may mimic a malignant or infectious process. Although these cases can present a diagnostic challenge, published cases of chronic contained rupture of an abdominal aortic aneurysm with vertebral body erosion demonstrate clinical and imaging similarities that, when recognized, can assist in diagnosis.

Association of a Frailty Screening Initiative With Postoperative Survival at 30, 180, and 365 Days.

Importance: As the US population ages, the number of operations performed on elderly patients will likely increase. Frailty predicts postoperative mortality and morbidity more than age alone, thus presenting opportunities to identify the highest-risk surgical patients and improve their outcomes. Objective: To examine the effect of the Frailty Screening Initiative (FSI) on mortality and complications by comparing the surgical outcomes of a cohort of surgical patients treated before and after implementation of the FSI. Design, Setting, and Participants: This single-site, facility-wide, prospective cohort quality improvement project studied all 9153 patients from a level 1b Veterans Affairs medical center who presented for major, elective, noncardiac surgery from October 1, 2007, to July 1, 2014. Interventions: Assessment of preoperative frailty in all patients scheduled for elective surgery began in July 2011. Frailty was assessed with the Risk Analysis Index (RAI), and the records of all frail patients (RAI score, ≥21) were flagged for administrative review by the chief of surgery (or designee) before the scheduled operation. On the basis of this review, clinicians from surgery, anesthesia, critical care, and palliative care were notified of the patient's frailty and associated surgical risks; if indicated, perioperative plans were modified based on team input. Main Outcomes and Measures: Postoperative mortality at 30, 180, and 365 days. Results: From October 1, 2007, to July 1, 2014, a total of 9153 patients underwent surgery (mean [SD] age, 60.3 [13.5] years; female, 653 [7.1%]; and white, 7096 [79.8%]). Overall 30-day mortality decreased from 1.6% (84 of 5275 patients) to 0.7% (26 of 3878 patients, P < .001) after FSI implementation. Improvement was greatest among frail patients (12.2% [24 of 197 patients] to 3.8% [16 of 424 patients], P < .001), although mortality rates also decreased among the robust patients (1.2% [60 of 5078 patients] to 0.3% [10 of 3454 patients], P < .001). The magnitude of improvement among frail patients increased at 180 (23.9% [47 of 197 patients] to 7.7% [30 of 389 patients], P < .001) and 365 days (34.5% [68 of 197 patients] to 11.7% [36 of 309 patients], P < .001). Multivariable models revealed improved survival after FSI implementation, controlling for age, frailty, and predicted mortality (adjusted odds ratio for 180-day survival, 2.87; 95% CI, 1.98-4.16). Conclusions and Relevance: Implementation of the FSI was associated with reduced mortality, suggesting the feasibility of widespread screening of patients preoperatively to identify frailty and the efficacy of system-level initiatives aimed at improving their surgical outcomes. Additional investigation is required to establish a causal connection.