Rate of Emergency Lower Extremity Amputations in the United States Among Medicare Beneficiaries.

OBJECTIVE: To determine the rate of emergency versus elective lower extremity amputations in the United States. BACKGROUND: Lower extremity amputation is a common endpoint for patients with poorly controlled diabetes and multilevel peripheral vascular disease. Although the procedure is ideally performed electively, patients with limited access may present later and require an emergency operation. To what extent rates of emergency amputation for lower extremities vary across the United States is unknown. METHODS: Evaluation of Medicare beneficiaries who underwent lower extremity amputation between 2015 and 2020. The rate was determined for each zip code and placed into rank order from lowest to highest rate. We merged each beneficiary's place of residence and location of care with the American Hospital Association Annual Survey using Google Maps Application Programming Interface to determine the travel distance for patients to undergo their procedure. RESULTS: Of 233,084 patients, 66.3% (154,597) were men, 69.8% (162,786) were White. The average age (SD) was 74 years (8). There was wide variation in rates of emergency lower extremity amputation. The lowest quintile of zip codes demonstrated an emergency amputation rate of 3.7%, whereas the highest quintile demonstrated 90%. The median travel distance in the lowest emergency surgery rate quintile was 34.6 miles compared with 10.5 miles in the highest quintile of emergency surgery ( P < 0.001). CONCLUSIONS: There is wide variation in the rate of emergency lower extremity amputations among Medicare beneficiaries, suggesting variable access to essential vascular care. Travel distance and rate of amputation have an inverse relationship, suggesting that barriers other than travel distance are playing a role.

Real-world application of Wound, Ischemia, and foot Infection scores in peripheral arterial disease patients.

OBJECTIVE: The Society for Vascular Surgery (SVS) Wound, Ischemia, and foot Infection (WIfI) classification system aims to risk stratify patients with chronic limb-threatening ischemia (CLTI), predicting both amputation rates and the need for revascularization. However, real-world use of the system and whether it predicts outcomes accurately after open revascularization and peripheral interventions is unclear. Therefore, we sought to determine the adoption of the WIfI classification system within a contemporary statewide collaborative as well as the impact of patient factor, and WIfI risk assessment on short- and long-term outcomes. METHODS: Using data from a large statewide collaborative, we identified patients with CLTI undergoing open surgical revascularization or peripheral vascular intervention (PVI) between 2016 and 2022. The primary exposure was preoperative clinical WIfI stage. Patients were categorized according to the SVS Lower Extremity Threatened Limb Classification System into clinical WIfI stages 1, 2, 3, or 4. The primary outcomes were 30-day and 1-year amputation and mortality rates. Multivariable logistic regression was performed to estimate the association of WIfI stage on postrevascularization outcomes. RESULTS: In the cohort of 17,417 patients, 83.4% (n = 14,529) had WIfI stage documented. PVIs were performed on 57.6% of patients, and 42.4% underwent an open surgical revascularization. Of the patients, 49.5% were classified as stage 1, 19.3% stage 2, 12.8% stage 3, and 18.3% of patients met stage 4 criteria. Stage 3 and 4 patients had higher rates of diabetes, congestive heart failure, and renal failure, and were less likely to be current or former smokers. One-half of stage 3 patients underwent open surgical revascularization, whereas stage 1 patients were most likely to have received a PVI (64%). As WIfI stage increased from 1 to 4, 1-year mortality increased from 12% to 21% (P < .001), 30-day amputation rates increased from 5% to 38% (P < .001), and 1-year amputation rates increased from 15% to 55% (P < .001). Finally, patients who did not have WIfI scores classified had significantly higher 30-day and 1-year mortality rates, as well as higher 30-day and 1-year amputation rates. CONCLUSIONS: The SVS WIfI clinical stage is significantly associated with 1-year amputation rates in patients with CLTI after lower extremity revascularization. Because nearly 55% of stage 4 patients require a major amputation within 1 year of intervention, this finding study supports use of the WIfI classification system in clinical decision-making for patients with CLTI.

Comparative evaluation of transcutaneous oxygen tension and ankle-brachial index as predictors of reoperation following below-knee amputation.

OBJECTIVE: Decision-making regarding level of lower extremity amputation is sometimes challenging. Selecting an appropriate anatomic level for major amputation requires consideration of tradeoffs between postoperative function and risk of wound complications that may require additional operations, including debridement and/or conversion to above-knee amputation (AKA). We evaluated the utility of common, non-invasive diagnostic tests used in clinical practice to predict the need for reoperations among patients undergoing primary, elective, below knee-amputations (BKAs) by vascular surgeons. METHODS: Patients undergoing elective BKA over a 5-year period were identified using Current Procedural Terminology codes. Medical records were reviewed to characterize demographics, pre-amputation testing transcutaneous oxygen tension (TcPO2), and ankle-brachial index (ABI). The need for ipsilateral post-BKA reoperation (including BKA revision and/or conversion to AKA) regardless of indication was the primary outcome. Associations were evaluated using univariable and multivariable logistic regression models. Cutpoints for TcPO2 values associated with amputation reoperation were evaluated using receiver operating characteristic curves. RESULTS: We identified 175 BKAs, of which 46 (26.3%) required ipsilateral reoperation (18.9% BKA revisions and 14.3% conversions to AKA). The mean age was 63.3 ± 14.8 years. Most patients were male (65.1%) and White (72.0%). Mean pre-amputation calf TcPO2 was 40.0 ± 20.5 mmHg, and mean ABI was 0.64 ± 0.45. In univariable models, post-BKA reoperation was associated with calf TcPO2 (odds ratio [OR], 0.97; 95% confidence interval [CI], 0.94-0.99; P = .013) but not ABI (OR, 0.53; 95% CI, 0.19-1.46; P = .217). Univariable associations with reoperation were also identified for age (OR, 0.97; 95% CI, 0.94-0.990; P = .003) and diabetes (OR, 0.43; 95% CI, 0.21-0.87; P = .019). No associations with amputation revision were identified for gender, race, end-stage renal disease, or preoperative antibiotics. Calf TcPO2 remained associated with post-BKA reoperation in a multivariable model (OR, 0.97; 95% CI, 0.94-0.99; P = .022) adjusted for age (OR, 0.98; 95% CI, 0.94-1.01; P = .222) and diabetes (OR, 0.98; 95% CI, 0.94-1.01; P = .559). Receiver operating characteristic analysis suggested a TcPO2 ≥38 mmHg as an appropriate cut-point for assessing risk for BKA revision (area under the curve = 0.682; negative predictive value, 0.91). CONCLUSIONS: Reoperation after BKA is common, and reoperation risk was associated with pre-amputation TcPO2. For patients undergoing elective BKA, higher risk of reoperation should be discussed with patients with an ipsilateral TcPO2 <38 mmHg.

Natural history of visceral branch artery dissections and the influence of concurrent aortic dissection on overall and intervention-free survival.

OBJECTIVE: Visceral branch artery dissection (VBAD) is uncommon and may occur with or without an associated aortic dissection (AD). We hypothesized that isolated VBAD would have a more benign clinical course than those with concurrent AD and compared survival outcomes stratified based on aortic involvement. METHODS: VBAD over a 5-year period were identified using International Classification of Diseases codes. Data related to patient demographics, comorbid conditions, clinical presentation, management (including procedural interventions), and survival were obtained from medical records. Anatomic imaging studies were reviewed to characterize anatomy, including the presence or absence of concurrent AD. Overall survival and intervention-free survival were evaluated using Kaplan-Meier and Cox proportional hazards models. RESULTS: A total of 299 VBAD were identified, 174 of which were isolated VBAD and 125 were associated with concurrent AD. Seventy-one percent of patients were men, 77% were White, and 85% were non-Hispanic. The mean age was 61.1 ± 14.4 years. The mean follow-up was 53.2 ± 50.0 months. The estimated overall survival was 88.2% and the estimated overall intervention-free survival was 55.6% at 12 months. Isolated VBAD had better overall survival than those with concurrent AD (69.2% vs 32.4%; P < .001). Concurrent AD was also associated with inferior intervention-free survival (57.5% vs 7.3%; P < .001). Acute presentation was associated with decreased intervention-free survival (86.1% vs 13.4%; P < .001). Acute presentation was also associated with decreased overall survival in patients with isolated VBAD (60.8% vs 80.0% at 180 months; P < .001) and inferior intervention-free survival (48.4% vs 69.5% at 180 months; P < .001) in the subgroup of patients with isolated VBAD. Multivariable Cox models identified that age (hazard ratio [HR]: 1.05, standard deviation [SD]: 0.02; P = .001) was associated with inferior survival and renal dissections (HR: 3.08, SD: 0.99; P = .001) or mesenteric and renal dissections (HR: 3.39, SD: 1.44; P = .004) were associated with inferior intervention-free survival. CONCLUSIONS: Isolated VBAD has superior overall and intervention-free survival to those associated with concurrent AD. The absence vs presence of aortic involvement is useful for risk stratification and may support tailored approaches to the frequency of imaging surveillance.

Direct and Indirect Effects of Race and Socioeconomic Deprivation on Outcomes After Lower Extremity Bypass.

OBJECTIVE: To evaluate the potential pathway, through which race and socioeconomic status, as measured by the social deprivation index (SDI), affect outcomes after lower extremity bypass chronic limb-threatening ischemia (CLTI), a marker for delayed presentation. BACKGROUND: Racial and socioeconomic disparities persist in outcomes after lower extremity bypass; however, limited studies have evaluated the role of disease severity as a mediator to potentially explain these outcomes using clinical registry data. METHODS: We captured patients who underwent lower extremity bypass using a statewide quality registry from 2015 to 2021. We used mediation analysis to assess the direct effects of race and high values of SDI (fifth quintile) on our outcome measures: 30-day major adverse cardiac event defined by new myocardial infarction, transient ischemic attack/stroke, or death, and 30-day and 1-year surgical site infection (SSI), amputation and bypass graft occlusion. RESULTS: A total of 7077 patients underwent a lower extremity bypass procedure. Black patients had a higher prevalence of CLTI (80.63% vs 66.37%, P < 0.001). In mediation analysis, there were significant indirect effects where Black patients were more likely to present with CLTI, and thus had increased odds of 30-day amputation [odds ratio (OR): 1.11, 95% CI: 1.068-1.153], 1-year amputation (OR: 1.083, 95% CI: 1.045-1.123) and SSI (OR: 1.052, 95% CI: 1.016-1.089). There were significant indirect effects where patients in the fifth quintile for SDI were more likely to present with CLTI and thus had increased odds of 30-day amputation (OR: 1.065, 95% CI: 1.034-1.098) and SSI (OR: 1.026, 95% CI: 1.006-1.046), and 1-year amputation (OR: 1.068, 95% CI: 1.036-1.101) and SSI (OR: 1.026, 95% CI: 1.006-1.046). CONCLUSIONS: Black patients and socioeconomically disadvantaged patients tended to present with a more advanced disease, CLTI, which in mediation analysis was associated with increased odds of amputation and other complications after lower extremity bypass compared with White patients and those that were not socioeconomically disadvantaged.

Identifying potentially avoidable femoral to popliteal expanded polytetrafluoroethylene bypass for claudication using cross-site blinded peer review.

OBJECTIVE: The surgical treatment of claudication can be associated with significant morbidity and costs. There are growing concerns that some patients proceed to interventions without first attempting evidence-based nonoperative management. We used a direct, cross-site, blinded expert review to evaluate the appropriateness of the surgical treatment of claudication. METHODS: We enlisted practicing vascular surgeons to perform retrospective clinical assessments of lower extremity bypass procedures in a statewide clinical registry. Cases were limited to elective, open, infrainguinal bypasses performed for claudication using prosthetic grafts. Reviewing surgeons were randomly assigned 10 cases from a sample of 139 anonymized bypass operations and instructed to evaluate procedural appropriateness based on their expert opinion and evidence-based guidelines for preoperative treatment, namely, antiplatelet, statin, cilostazol, exercise, and smoking cessation therapy as documented in the medical record. Ninety-day episode payments were estimated from a distinct but similar cohort of patients undergoing lower extremity bypass for claudication. RESULTS: Of 325 total reviews, surgeons stated they would not have recommended bypass in 134 reviews (41%) and deemed bypass inappropriate in 122 reviews (38%). The most common reason for inappropriateness was lack of preoperative medical and lifestyle therapy, which was present in 63% of reviews where bypass was deemed appropriate and 39% of reviews where bypass was deemed inappropriate (P < .001). Surgeons stated they would have recommended additional preoperative therapy in 65% of reviews where bypass was deemed inappropriate and 35% of reviews where bypass was deemed appropriate (P < .001). The mean total episode payments in a similar cohort of 1458 patients undergoing elective open lower extremity bypass for claudication were $31,301 ± $21,219. Extrapolating to the 325 reviews, the 134 reviews in which surgeons would not have recommended bypass were associated with potentially avoidable estimated total payments of $4,194,334, and the 122 reviews in which bypass was deemed inappropriate were associated with potentially avoidable estimated total payments of $3,818,722. CONCLUSIONS: In this cross-site expert peer review study, 40% of lower extremity bypasses were deemed premature and, therefore, potentially avoidable, primarily owing to a lack of medical and lifestyle management before surgery. Reviews deemed inappropriate were associated with approximately $4 million in potentially avoidable costs. This approach could inform performance feedback among surgeons to help align clinical practice with evidence-based recommendations for the treatment of claudication.

Characterizing patient-reported claudication treatment goals to support patient-centered treatment selection and measurement strategies.

OBJECTIVE: Patient-reported outcomes (PRO) have been increasingly emphasized for peripheral artery disease (PAD). Patient-defined treatment goals and expectations, however, are poorly understood and might not be achievable or aligned with guidelines or clinical outcomes. We evaluated the patient-reported treatment goals among patients with claudication and the associations between patient characteristics, goals, and PAD-specific PRO scores. METHODS: Patients with a diagnosis of claudication were prospectively recruited. Patient-defined treatment goals and outcomes related to walking distance, duration, and speed were quantified using multiple-choice survey items. Free-text items were used to identify activities other than walking distance, duration, or speed associated with symptoms and treatment goals. The peripheral artery disease quality of life and walking impairment questionnaire instruments were included as PRO. The treatment goal categories were compared with the PRO percentile scores using 95% confidence intervals (CIs), categorical tests, and logistic regression models. Associations between the patient characteristics and PRO were evaluated using linear and ordinal logistic regression models. RESULTS: A total of 150 patients meeting the inclusion criteria were included in the present study. Of these 150 patients, 144 (96%) viewed the entire survey. Their mean age was 70.0 ± 11.3 years, and 32.9% were women. Most of the respondents had self-reported their race as White (n = 135), followed by Black (n = 3), Asian (n = 2), Native American (n = 2), and other/unknown (n = 2). Two participants self-reported Hispanic ethnicity. The primary treatment goals were an increased walking distance or duration without stopping (62.0%), the ability to perform a specific activity or task (23.0%), an increased walking speed (8.0%), or other/none of the above (7.0%). The specific activities associated with symptoms or goals included outdoor recreation (38.5%), labor-related tasks (30.7%), sports (26.9%), climbing stairs (23.1%), uphill walking (19.2%), and shopping (6%). Among the patients choosing an increased walking distance and duration as the primary goals, 64% had indicated that a distance of ≥0.5 mile (2640 ft) and 59% had indicated a duration of ≥30 minutes would be a minimum increase consistent with meaningful improvement. Increasing age was associated with lower odds of a distance improvement goal of ≥0.5 mile (odds ratio [OR], 0.68 per 5 years; 95% CI, 0.51-0.92; P = .012) or duration improvement goal of ≥30 minutes (OR, 0.76 per 5 years; 95% CI, 0.58-0.99; P = .047). Patient characteristics associated with PAD Quality of Life percentile scores included age, ankle brachial index, and gender. Ankle brachial index was the only patient characteristic associated with the walking impairment questionnaire percentile scores. CONCLUSIONS: Patients define treatment goals according to their desired activities and expectations, which may influence their goals and perceived outcomes. Patients' expectations of minimum increases in walking distance and duration consistent with meaningful improvement exceeded reported minimum important difference criteria for many patients and would not be captured using common clinic-based walking tests. Patient age was associated with both treatment goals and PRO scores, and the related floor and ceiling effects could influence sensitivity to PRO changes for younger and older patients, respectively. Heterogeneity in treatment goals supports consideration of tailored decision-making and outcomes informed by patient characteristics and perspectives.

Focus group study of factors relevant to treatment decisions and experiences among patients with symptomatic peripheral artery disease.

BACKGROUND: Clinical guidelines recommend shared decision-making for treatment of peripheral artery disease (PAD), which requires understanding of patient perspectives and preferences. We conducted a focus group study of patients with symptomatic PAD to identify factors important and relevant to treatment choices, and to characterize aspects of the health care process that contribute to positive vs negative experiences apart from the specific treatment(s) received. METHODS: Participants were recruited from an academic medical center over 2 years using a purposeful sampling approach based on a clinical diagnosis of symptomatic PAD (either claudication or chronic limb-threatening ischemia [CLTI]) confirmed by the abnormal ankle or toe brachial index. Focus groups were led by a nonphysician moderator, consisted of 5 to 12 participants, and were conducted separately for patients with CLTI and claudication. Audio recordings converted to verbatim transcripts were used for qualitative analysis. RESULTS: A total of 51 patients (26 with CLTI and 25 with claudication) were enrolled and participated in focus groups. Major themes identified related to treatment preferences and decisions included specific interventions under consideration, the chance of technical success versus failure, anticipated degree of symptom improvement, outcome durability, and risk. Major themes related to the process of care included decision-making input, provider communication and trust, the timeline from diagnosis to definitive treatment, and compartmentalized care (including different venues of care). CONCLUSIONS: The results provide insights into patient preferences, perspectives, and experiences related to PAD treatment. These observations can be used to inform patient-centered approaches to shared decision-making, communication, and assessment of PAD treatment outcomes.

Outpatient grip strength measurement predicts survival, perioperative adverse events, and nonhome discharge among patients with vascular disease.

OBJECTIVES: Frailty is associated with adverse outcomes among patients with vascular disease. Grip strength measurement is a comparatively simple, quick, and inexpensive screening test for weakness (a component of frailty) that is potentially applicable to clinical practice. We hypothesized that grip strength and categorical weakness are associated with clinical outcomes among patients with vascular disease. To test this hypothesis, we conducted a longitudinal cohort study evaluating associations between grip strength measured during outpatient clinic visits for vascular disease and clinical outcomes, including survival and perioperative outcomes. METHODS: Adult patients recruited from outpatient vascular surgery and/or vascular medicine clinics underwent dominant hand grip strength measurement using a hand dynamometer. Participants were categorized as weak based on grip strength, sex, and body mass index. Multivariable logistic models were used to evaluate perioperative outcomes. Mortality was evaluated using Cox proportional hazards models adjusted for sex, age, and operative intervention during follow-up. RESULTS: We enrolled 321 participants. The mean patients age was 69.0 ± 9.4 years, and 33% were women. Mean grip strength was 32.0 ± 12.1 kg, and 92 participants (29%) were categorized as weak. The median follow-up was 24.0 months. Adverse perioperative events occurred in 32 of 84 patients undergoing procedures. Grip strength was associated with decreased risk of perioperative adverse events (hazard ratio [HR], 0.41 per 12.7 kg increase; 95% confidence interval [CI], 0.20-0.85; P = .0171) in a model adjusted for open versus endovascular procedure (HR, 12.75 for open; 95% CI, 2.54-63.90; P = .0020) and sex (HR, 3.05 for male; 95% CI, 0.75-12.4; P = .120). Grip strength was also associated with a lower risk of nonhome discharge (HR, 0.34 per 12.7 kg increase; 95% CI, 0.14-0.82; P = .016) adjusted for sex (HR, 2.14 for male; 95% CI, 0.48-9.50; P = .31) and open versus endovascular procedure (HR, 10.36 for open; 95% CI, 1.20-89.47; P = .034). No associations between grip strength and length of stay were observed. Mortality occurred in 48 participants (14.9%) during follow-up. Grip strength was inversely associated with mortality (HR, 0.46 per 12.5 kg increase; 95% CI, 0.29-0.73; P = .0009) in a model adjusted for sex (HR, 5.08 for male; 95% CI, 2.1-12.3; P = .0003), age (HR, 1.04 per year; 95% CI, 1.01-1.08), and operative intervention during follow-up (HR, 1.23; 95% CI, 0.71-2.52). Categorical weakness was also associated with mortality (HR, 1.81 vs nonfrail; P = .048) in a model adjusted for age (HR, 1.06 per year; P = .002) and surgical intervention (HR, 1.36; 95% CI, 1.02-0.09; P = .331). CONCLUSIONS: Grip strength is associated with all-cause mortality, perioperative adverse events, and nonhome discharge among patients with vascular disease. These observations support the usefulness of grip strength as a simple and inexpensive risk screening tool for patients with vascular disease.

Exploring the rapid expansion of office-based laboratories and peripheral vascular interventions across the United States.

OBJECTIVE: To characterize the relationship between office-based laboratory (OBL) use and Medicare payments for peripheral vascular interventions (PVI). METHODS: Using the Centers for Medicare and Medicaid Services Provider Utilization and Payment Data Public Use Files from 2014 to 2017, we identified providers who performed percutaneous transluminal angioplasty, stent placement, and atherectomy. Procedures were aggregated at the provider and hospital referral region (HRR) level. RESULTS: Between 2014 and 2017, 2641 providers performed 308,247 procedures. The mean payment for OBL stent placement in 2017 was $4383.39, and mean payment for OBL atherectomy was $13,079.63. The change in the mean payment amount varied significantly, from a decrease of $16.97 in HRR 146 to an increase of $43.77 per beneficiary over the study period in HRR 11. The change in the rate of PVI also varied substantially, and moderately correlated with change in payment across HRRs (R2 = 0.40; P < .001). The majority of HRRs experienced an increase in rate of PVI within OBLs, which strongly correlated with changes in payments (R2 = 0.85; P < .001). Furthermore, 85% of the variance in change in payment was explained by increases in OBL atherectomy (P < .001). CONCLUSIONS: A rapid shift into the office setting for PVIs occurred within some HRRs, which was highly geographically variable and was strongly correlated with payments. Policymakers should revisit the current payment structure for OBL use and, in particular atherectomy, to better align the policy with its intended goals.

Elective Surgical Delays Due to COVID-19: The Patient Lived Experience.

BACKGROUND: This qualitative research explored the lived experiences of patients who experienced postponement of elective cardiac and vascular surgery due to coronavirus disease 2019 (COVID-19). We know very little about patients during the novel coronavirus pandemic. Understanding the patient voice may play an important role in prioritization of postponed cases and triage moving forward. METHODS: Utilizing a hermeneutical phenomenological qualitative design, we interviewed 47 individuals who experienced a postponement of cardiac or vascular surgery due to the COVID-19 pandemic. Data were analyzed and informed by phenomenological research methods. RESULTS: Patients in our study described 3 key issues around their postponement of elective surgery. Patients described robust narratives about the meanings of their elective surgeries as the chance to "return to normal" and alleviate symptoms that impacted everyday life. Second, because of the meanings most of our patients ascribed to their surgeries, postponement often took a toll on how patients managed physical health and emotional well-being. Finally, paradoxically, many patients in our study were demonstrative that they would "rather die from a heart attack" than be exposed to the coronavirus. CONCLUSIONS: We identified several components of the patient experience, encompassing quality of life and other desired benefits of surgery, the risks of COVID, and difficulty reconciling the 2. Our study provides significant qualitative evidence to inform providers of important considerations when rescheduling the backlog of patients. The emotional and psychological distress that patients experienced due to postponement may also require additional considerations in postoperative recovery.

Industry Compensation to Physician Vascular Specialist Authors of Highly-referenced Aortic Aneurysm Studies.

BACKGROUND: Industry payments to physicians may influence their attitudes toward medical devices and products. Disclosure of industry compensation by authors of scientific manuscripts usually occurs at the authors' discretion and is seldom audited as part of the peer review process. The purpose of this analysis was to characterize industry compensation among highly cited research articles related to aortic aneurysm. METHODS: A Web of Science search for English language articles published from 2013-2017 using the search term "aortic aneurysm" identified publications for this study. The top 99 most-cited publications were abstracted by author. Physician authors with reported industry compensation from 2013-2016 were identified using the ProPublica Dollars for Docs search tool (linked to Centers for Medicare and Medicaid Services Open Payments data), based on provider name, medical specialty, and geographic location. Statistical analysis included descriptive statistics and categorical tests. RESULTS: The 99 articles had 1,264 unique authors, of whom 105 physicians (8.3%) received industry compensation during the study period. Fourteen of the 105 authors self-reported having received industry compensation. The remaining 91 authors (86.7%) did not disclose their industry-reported compensation. Industry payments during the study period totaled $6,082,574 paid through 13,489 transactions from 169 different manufacturers. In-kind items and services were the most common form of payment (65.3%). The median transaction amount was $58.32. [$138.34]. Food and beverage accounted for the largest number of transactions (N=9653), followed by travel and lodging (N=2365), consulting (N=513), and promotional speaking (N=436). Consulting accounted for the most total dollars over the study period ($1,970,606), followed by travel and lodging ($1,122,276), promotional speaking ($972,894), food and beverage ($568,251), royalty or license ($504,631), honoraria ($452,167), and education ($428,489). Royalty and license payments had the highest median transaction amount ($15,418. [$29,049]), and was the only category with a median transaction amount greater than $5,000. In contrast, several categories had median transaction amounts under $50, including food and beverage ($32. [$77]), gifts ($34. [$86]), and entertainment ($30. [$69]). No significant difference in payment amounts by medical specialty was identified (P=0.071). CONCLUSIONS: Only 8.3% of physician authors of highly cited aortic aneurysm studies received industry compensation, but 86.7% of those physician authors receiving payments did not disclose industry compensation within the manuscripts. Potential bias associated with industry compensation may be underestimated and conservatively biased based on author self-reporting.

Evaluation of Neuropathy, Glycemic Control, and Revascularization as Risk Factors for Future Lower Extremity Amputation among Diabetic Patients.

BACKGROUND: Diabetes mellitus is a major risk factor for progression to lower extremity amputation (LEA) due to progressive neuropathy and glycemia-induced vasculopathy. In this study, we evaluated risk factors for incident LEA type 2 diabetics during a randomized controlled trial and extended post-trial follow-up. METHODS: The Action to Control Cardiovascular Risk in Diabetes trial randomized 10,251 type 2 diabetics to intensive glycemic control (Hemoglobin A1c (HbA1c) target <6.0%) versus standard glycemic control (HbA1c target 7.0-7.9%). Using backward elimination logistic regression models, we examined relationships between neuropathy using the Michigan Neuropathy Screening Instrument (MNSI) and glycemic control and incident LEA during the clinical trial and subsequent follow-up. RESULTS: 9,746 patients were followed for a mean of 7.9 +/-3.1 (median 8.9) years after randomization. Ninety-eight (1%) participants underwent an incident LEA during the trial or post-trial follow-up period. Baseline demographics and traditional risk factors were examined by incident amputation status. Multivariable models revealed that abnormal 10 gm filament test (HR 4.50, 95% CI 2.92-6.95, P < 0.0001), presence of ulceration (HR 4.22, 95% CI 1.65-10.8, P = 0.0004), abnormal appearance on foot examination (HR 4.75, 95% CI 2.30-9.83, P < 0.0001), and mean postrandomization HbA1c (HR 1.65, 95% CI 1.35-2.00, P < 0.0001) were strongly predictive of LEA when accounting for other common risk factors for amputation. CONCLUSIONS: In this post hoc analysis of a large randomized controlled population of diabetic patients, we found that components of the MNSI score including presence of ulceration, abnormal appearance of the foot, and 10 gm filament monofilament scoring were strongly predictive of LEA. This adds a valuable clinical tool in the risk stratification of diabetic patients for LEA.

Developing Strategies for Targeted Improvement of Perioperative Education for Postbariatric Surgery Body-Contouring Patients.

BACKGROUND: The quality of perioperative patient education impacts surgical outcomes, patient experiences, and resources needed to address patient concerns and unplanned visits. We examined patient inquiries and education materials to assess the quality of perioperative education and identify areas of targeted improvement for postbariatric surgery body-contouring procedures. METHODS: We examined 100 consecutive postbariatric procedures at an academic center. Themes of patient-generated calls, e-mails, and electronic medical record portal messages during the perioperative period were identified via qualitative analysis. Understandability and actionability of perioperative educational resources were assessed using the Patient Education Materials Assessment Tool (PEMAT). RESULTS: Among 212 communications identified, 167 (79%) were postoperative. Common themes were concerns regarding the surgical site (38%), medications (10%), and activity restrictions (10%). One hundred thirty inquiries were resolved through patient re-education (57%), but 36 (16%) required in-person evaluation including 4 unplanned emergency department visits and 3 readmissions for surgical-site concerns. The PEMAT scores for institutional materials were fair for understandability (69%) and actionability (60%). American Society of Plastic Surgeons materials were more understandable (84%) but less actionable (40%). CONCLUSIONS: Patient queries can be leveraged as a source of qualitative data to identify gaps in perioperative education. High-yield topics, such as education regarding the surgical site and medications, can be targeted for quality improvement through better communication and potentially reduce the number of unnecessary visits. Using the PEMAT, we also identified how directly the education materials can be revised. Improving perioperative education can promote mutual understanding between patients and surgeons, better outcomes, and efficient resource utilization.

Industry compensation and self-reported financial conflicts of interest among authors of highly cited peripheral artery disease studies.

OBJECTIVE: Industry compensation to authors may influence the interpretation of study results. Scientific journals often require author disclosure of a relevant financial conflict of interest (FCOI) but seldom quantify compensation and leave reporting up to the author's discretion. Professional and public concerns related to potential bias introduced into medical research by FCOI have arisen, especially when physician compensation from manufacturers is not disclosed. Little is known, however, about the prevalence of industry compensation to authors of related publications, payment amounts, or how this information compares with self-reported FCOI. The objective of this study was to compare industry compensation and disclosed FCOI among highly referenced publications related to treatment of peripheral artery disease, a disease that affects approximately 8.5 million Americans and is often treated with medications and devices. METHODS: "Peripheral artery disease" was used as a Web of Science search term to identify publications from 2013 to 2016, excluding review articles, conference proceedings, book chapters, abstract publications, and non-English language publications. The top 99 most cited publications were abstracted for self-reported FCOI by author. Industry compensation to authors was queried using a ProPublica Dollars for Docs custom data set based on Centers for Medicare and Medicaid Services Open Payments data. Providers practicing in the United States in any of the following specialties were included: cardiology, cardiothoracic surgery, vascular and interventional radiology, or vascular surgery. Payment transactions were matched to physician authors on the basis of provider name, specialty, and geographic location. Statistical analysis included descriptive statistics and categorical tests. Descriptive statistics are reported as frequency (percentage) or median (interquartile range). RESULTS: Among 1008 vascular specialist authors identified, 218 (22%) self-reported FCOI. Fifty-six physician authors had compensation reported to the Centers for Medicare and Medicaid Services by industry during the study period. Among those identified as recipients of industry compensation, 28 (50%) self-reported FCOI. Industry payments to the 56 authors totaled $11,139,987, with a median total payment of $18,827 (interquartile range, $152,084) per author. Food and beverage was the most frequently identified nature of payment (n = 8981 [74%]), promotional speaking involved the largest total amount of payments ($3,256,431), and royalty or license was the highest median payment ($51,431 [$72,215]). Physicians reporting FCOI received a total of $9,435,340 during the study period vs $1,706,647 for those who did not report any FCOI. Median total payments were higher among authors reporting FCOI vs not ($81,224 [$324,171] vs $9494 [$43,448]; P < .001). CONCLUSIONS: Nondisclosed author compensation from industry is relatively uncommon among highly cited peripheral artery disease research studies but may be associated with substantial payments. These results suggest that self-reported FCOI does not provide a comprehensive overview of industry compensation. Reporting all payments rather than only those deemed relevant by the author might provide a more complete and transparent report of potential FCOI, allowing independent assessment of relevance in interpreting study findings.

Scope, Themes, and Medical Accuracy of eHealth Peripheral Artery Disease Community Forums.

BACKGROUND: The availability of electronic health (eHealth) information and disease-related community forums has grown over the last decade. Although patients and families frequently use these resources, their content has not been characterized in terms users, content, or reliability of information. eHealth communities therefore represent a potentially valuable but uncharted source of information about key patient issues, communication terminology, and unmet needs. We hypothesized that eHealth forums would contain terminology, themes, and advice inconsistent with resources from medical providers and references. To test this hypothesis, we performed a qualitative analysis of posts and responses from an open-access peripheral artery disease (PAD) eHealth community forum to characterize the discussion, participants, and the information being exchanged. METHODS: Posts were collected from an online PAD Medical Support Community forum (MedHelp), which is open access, does not require participants to identify themselves, and is based in the United States. Posts were selected from threads in which the main topic was PAD, including diagnosis, symptoms, and treatment. Original posts and related responses were analyzed for thematic content, common vernacular, and self-reported characteristics of the participants using a qualitative analysis software program. Disease-specific comments and advice were evaluated for congruence with contemporary PAD treatment guidelines. RESULTS: A total of 103 posts were collected and analyzed, including 40 original posts and 63 responses. Forty-five percent of the original posts and 19% of the responses were authored by participants who self-identified as patients with PAD. The remaining posts were authored by people with undeclared relationships to patients with PAD, followed by children, spouses, and other relatives. The most common themes among original posts included PAD diagnosis (and differential) (25%), treatment (23%), epidemiology and pathophysiology (21%), disease symptoms and impacts on activities of daily living (15%), and health-care provider recommendations (13%). Themes of responses included medical advice (40.5%), personal experiences with PAD (32.8%), and social support (12.6%). Negative attitudes were identified in 10 of 18 (55.6%) posts related to experiences with health-care providers. Of all medical advice, 15.1% was inconsistent with clinical treatment guidelines. CONCLUSION: eHealth communities are a rich source of information related to the experiences of patients with PAD, their treatment preferences, questions they consider important, and terminology that they use. This information can be used to understand unmet patient needs, develop educational resources, and improve communication.

The Effects of Case Timing and Care Team Composition on Hospital Operating Room Costs for Endovascular Procedures.

BACKGROUND: The contemporary healthcare environment is complex with mounting pressures to perform greater procedural volumes with less support staff to minimize costs and maximize efficiency. This report details an analysis of routine endovascular procedures performed with dedicated vascular support staff during daytime hours compared to similar cases performed after hours with general operating room staff. METHODS: All lower extremity endovascular cases over a 37-month period were identified using Current Procedural Terminology codes from a query of our institutional database. Emergent/urgent cases and cases with associated open surgical procedures were excluded. Cases were divided according to the time of day and available clinical support structure according to procedure start time: specialty-specific daytime (SS) and general staff after hours for all others (AH). The resulting case list was examined by case type according to SS or AH designation and case types occurring disproportionately during either time frame were excluded to create a homogenous group of cases. Demographics, case specifics, and cost data were then obtained from the electronic health record and our enterprise cost data warehouse. Multivariable mixed linear modeling was used to examine component costs (i.e., anesthesia, supplies, etc.) and total costs controlling for a number of factors that could affect cost. RESULTS: Two hundred fifty-two routine endovascular-only procedures were examined in 232 patients (190 SS, 42 AH). No significant differences in procedure specifics were observed between the groups [number and location of access site(s), indication for procedure, type and number of interventions, etc.]. Multivariable analyses controlled for factors affecting costs. Costs associated with anesthesia (cost ratio 1.90, P = 0.001), operating room time costs (cost ratio 1.29, P = 0.03), and post anesthesia recovery (cost ratio 1.23, P = 0.004) were all significantly increased in AH cases compared to SS cases. The average total hospital cost for routine endovascular cases that performed AH was $8,095 compared to $5,636 for SS cases (cost ratio 1.44, P = 0.008). CONCLUSIONS: Performance of routine endovascular cases was associated with significantly less cost to the hospital system when performed by SS teams during regular hospital hours with a ∼30% increase in total cost associated with AH cases. In the current healthcare environment, investments in SS teams and process improvements are likely to be cost effective.

Development, Launch, and Evaluation of an Open-Access Vascular Surgery Handbook through House Officer Curriculum Crowdsourcing.

BACKGROUND: Free digital platforms are smartphone-compatible and permit self-directed curriculum development based on learners' interests and educational needs. We developed a free mobile vascular surgery handbook initiated, authored, and edited by surgical house officers and surveyed on the content and users. METHODS: Using a free digital platform, house officers developed a vascular surgery handbook. Initiated by a single user for conference preparation and clinical care, the use expanded through sharing among residents. The handbook was then deployed at a second medical center, with free access granted to users after completing a survey. Handbook and content use were evaluated based on user ratings ≥4 on a Likert scale from 1 to 5, where 1 = "strongly disagree" and 5 = "completely agree." Domains assessed included handbook ease of use, content, and relevance to a variety of learning environments and goals (e.g., preparation for the operating room, rounds, clinic, teaching conferences, and examinations). Analytic methods included qualitative analysis, graphical evaluation, and categorical tests. RESULTS: The handbook is organized into sections, with each consisting of multiple pages and/or posts related to the section topic. Sections with the most content included lower extremity arterial disease, endovascular aneurysm repair/thoracic endovascular aortic repair, venous disease, anticoagulation, and anatomy/exposures. Fifty-four users participated in the evaluation phase, including different types of surgical residents (35%), medical students (30%), and anesthesia residents (22%). Sixty-nine percent of participants were in their position for <2 years. The average age was 29.1 years, and 57% were women. Preferred learning styles among users at the time of enrollment primarily included question banks (52%), followed by slide-based lectures (15%) and "chalk talk" lectures (13%). Of the users who participated in the presurvey, 43 users participated in the postsurvey with a general agreement on the handbook being an easy-to-use resource that was useful for gaining overall knowledge and contained accurate information. Users generally agreed they would recommend the handbook to a colleague. CONCLUSIONS: References customized to user needs can be developed through crowdsourcing and published with free digital resources. These approaches allow mobile access to useful information during conferences and clinical care. House officers' self-perceived educational needs can be targeted for tailored educational initiatives.

Grip strength measurement for frailty assessment in patients with vascular disease and associations with comorbidity, cardiac risk, and sarcopenia.

OBJECTIVE: Frailty is associated with adverse events, length of stay, and nonhome discharge after vascular surgery. Frailty measures based on walking-based tests may be impractical or invalid for patients with walking impairment from symptoms or sequelae of vascular disease. We hypothesized that grip strength is associated with frailty, comorbidity, and cardiac risk among patients with vascular disease. METHODS: Dominant hand grip strength was measured during ambulatory clinic visits among patients with vascular disease (abdominal aortic aneurysm [AAA], carotid stenosis, and peripheral artery disease [PAD]). Frailty prevalence was defined on the basis of the 20th percentile of community-dwelling population estimates adjusted for age, gender, and body mass index. Associations between grip strength, Charlson Comorbidity Index (CCI), Revised Cardiac Risk Index (RCRI), and sarcopenia (based on total psoas area for patients with cross-sectional abdominal imaging) were evaluated using linear and logistic regression. RESULTS: Grip strength was measured in 311 participants; all had sufficient data for CCI calculation, 217 (69.8%) had sufficient data for RCRI, and 88 (28.3%) had cross-sectional imaging permitting psoas measurement. Eighty-six participants (27.7%) were categorized as frail on the basis of grip strength. Frailty was associated with CCI (odds ratio, 1.86; 95% confidence interval, 1.34-2.57; P = .0002) in the multivariable model. Frail participants also had a higher average number of RCRI components vs nonfrail patients (mean ± standard deviation, 1.8 ± 0.8 for frail vs 1.5 ± 0.7 for nonfrail; P = .018); frailty was also associated with RCRI in the adjusted multivariable model (odds ratio, 1.75; 95% confidence interval, 1.16-2.64; P = .008). Total psoas area was lower among patients categorized as frail vs nonfrail on the basis of grip strength (21.0 ± 6.6 vs 25.4 ± 7.4; P = .010). Each 10 cm2 increase in psoas area was associated with a 5.7 kg increase in grip strength in a multivariable model adjusting for age and gender (P < .0001). Adjusted least squares mean psoas diameter estimates were 25.5 ± 1.1 cm2 for participants with AAA, 26.7 ± 2.0 cm2 for participants with carotid stenosis, and 22.7 ± 0.8 cm2 for participants with PAD (P = .053 for PAD vs AAA; P = .057 for PAD vs carotid stenosis; and P = .564 for AAA vs carotid stenosis). CONCLUSIONS: Grip strength is useful for identifying frailty among patients with vascular disease. Frail status based on grip strength is associated with comorbidity, cardiac risk, and sarcopenia in this population. These findings suggest that grip strength may have utility as a simple and inexpensive risk screening tool that is easily implemented in ambulatory clinics, avoids the need for imaging, and overcomes possible limitations of walking-based measures. Lower mean psoas diameters among patients with PAD vs other diagnoses may warrant consideration of specific approaches to morphomic analysis.