Comparative evaluation of transcutaneous oxygen tension vs 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.

Neuropathy Screening for Patients with Peripheral Vascular Disease Helps to Identify Those at an Increased Risk of Amputation, Revascularization, and Death.

BACKGROUND: Peripheral neuropathy is associated with amputation risk among patients with diabetes mellitus and chronic limb-threatening ischemia (CLTI). Detection of peripheral neuropathy may help identify those who are at an increased risk, but the predictive ability of the screening tool used in patients with peripheral arterial disease (PAD) needs to be more clearly defined. METHODS: Patients referred to vascular surgery clinic for PAD were recruited from a single center. Exclusion criteria were a documented history of neuropathy or prior lower limb amputation. Screening utilized the Michigan Neuropathy Screening Instrument (MNSI). Scores >2.5 were considered abnormal and scores >4 were considered positive for peripheral neuropathy. Limb-specific outcomes of amputation and revascularization as well as a composite outcome including death were modeled using time to event analysis. RESULTS: 86 patients were recruited. Mean age was 67 ± 10.2 years, 30% were women, 24% were black. Mean ankle-brachial index was 0.74 ± 0.3. PAD symptoms at initial evaluation were claudication in 52% of patients and CLTI in 38% of patients. Neuropathy was present in 20% of the cohort with a significantly higher proportion in diabetics (34% vs. 3%; P = 0.0009). Neuropathy was more common in patients with CLTI compared to claudicants (36% vs. 9%; P = 0.011). Forty patients (47%) reached the composite outcome of amputation, revascularization, or death with a median time to event of 16 months. Abnormal MNSI examination was significantly associated with the increased risk of the composite outcome (hazard ratio = 3.19; P 0.0005). CONCLUSIONS: A significant proportion of patients presenting to vascular specialists for PAD have undiagnosed neuropathy. Patients with PAD and neuropathy have an increased risk of amputation, revascularization, and death. Expanding neuropathy screening in vascular surgery clinic visits may help to identify patients at higher risk.

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.

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. While 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 extremity vary across the United States is unknown. METHODS: Evaluation of Medicare beneficiaries who underwent lower extremity amputation between 2015-2020. 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. Average age(SD) was 74 year(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% while the highest quintile demonstrated 90%. Median travel distance in the lowest emergency surgery rate quintile was 34.6 miles compared to 10.5 miles in the highest quintile of emergency surgery (P<0.001). CONCLUSION: 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 amputation have an inverse relationship, suggesting that barriers other than travel distance are playing a role.

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.

Automated Electronic Frailty Index is Associated with Non-home Discharge in Patients Undergoing Open Revascularization for Peripheral Vascular Disease.

BACKGROUND: Frailty is associated with adverse surgical outcomes including post-operative complications, needs for post-acute care, and mortality. While multiple frailty screening tools exist, most are time and resource intensive. Here we examine the association of an automated electronic frailty index (eFI), derived from routine data in the Electronic Health Record (EHR), with outcomes in vascular surgery patients undergoing open, lower extremity revascularization. METHODS: A retrospective analysis at a single academic medical center from 2015 to 2019 was completed. Information extracted from the EHR included demographics, eFI, comorbidity, and procedure type. Frailty status was defined as fit (eFI≤0.10), pre-frail (0.100.21). Outcomes included length of stay (LOS), 30-day readmission, and non-home discharge. RESULTS: We included 295 patients (mean age 65.9 years; 31% female), with the majority classified as pre-frail (57%) or frail (32%). Frail patients exhibited a higher degree of comorbidity and were more likely to be classified as American Society of Anesthesiologist class IV (frail: 46%, pre-frail: 27%, and fit: 18%, P = 0.0012). There were no statistically significant differences in procedure type, LOS, or 30-day readmissions based on eFI. Frail patients were more likely to expire in the hospital or be discharged to an acute care facility (31%) compared to pre-frail (14%) and fit patients (15%, P = 0.002). Adjusting for comorbidity, risk of non-home discharge was higher comparing frail to pre-frail patients (OR 3.01, 95% CI 1.40-6.48). DISCUSSION: Frail patients, based on eFI, undergoing elective, open, lower extremity revascularization were twice as likely to not be discharged home.

Assessment of Patterns of Atherectomy Use.

Background Atherectomy has become the fastest growing catheter-based peripheral vascular intervention performed in the United States, and overuse has been linked to increased reimbursement, but the patterns of use have not been well characterized. Methods and Results We used Blue Cross Blue Shield of Michigan Preferred Provider Organization and Medicare fee-for-service professional claims data from the Michigan Value Collaborative for patients undergoing office-based laboratory atherectomy in 2019 to calculate provider-specific rates of atherectomy use, reimbursement, number of vessels treated, and number of atherectomies per patient. We also calculated the rate that each provider converted a new patient visit to an endovascular procedure within 90 days. Correlations between parameters were assessed with simple linear regression. Providers completing ≥20 office-based laboratory atherectomies and ≥20 new patient evaluations during the study period were included. A total of 59 providers performing 4060 office-based laboratory atherectomies were included. Median professional reimbursement per procedure was $4671.56 (interquartile range [IQR], $2403.09-$7723.19) from Blue Cross Blue Shield of Michigan and $14 854.49 (IQR, $9414.80-$18 816.33) from Medicare, whereas total professional reimbursement from both payers ranged from $2452 to $6 880 402 per year. Median 90-day conversion rate was 5.0% (IQR, 2.5%-10.0%), whereas the median provider-level average number of vessels treated per patient was 1.20 (IQR, 1.13-1.31) and the median provider-level average number of treatments per patient was 1.38 (IQR, 1.26-1.63). Total annual reimbursement for each provider was directly correlated with new patient-procedure conversion rate (R2=0.47; P<0.001), mean number of vessels treated per patient (R2=0.31; P<0.001), and mean number of treatments per patient (R2=0.33; P<0.001). Conclusions A minority of providers perform most procedures and are reimbursed substantially more per procedure compared with most providers. Procedural conversion rate, number of vessels, and number of treatments per patient represent potential policy levers to curb overuse.

Macrophage-specific inhibition of the histone demethylase JMJD3 decreases STING and pathologic inflammation in diabetic wound repair.

Macrophage plasticity is critical for normal tissue repair following injury. In pathologic states such as diabetes, macrophage plasticity is impaired, and macrophages remain in a persistent proinflammatory state; however, the reasons for this are unknown. Here, using single-cell RNA sequencing of human diabetic wounds, we identified increased JMJD3 in diabetic wound macrophages, resulting in increased inflammatory gene expression. Mechanistically, we report that in wound healing, JMJD3 directs early macrophage-mediated inflammation via JAK1,3/STAT3 signaling. However, in the diabetic state, we found that IL-6, a cytokine increased in diabetic wound tissue at later time points post-injury, regulates JMJD3 expression in diabetic wound macrophages via the JAK1,3/STAT3 pathway and that this late increase in JMJD3 induces NFκB-mediated inflammatory gene transcription in wound macrophages via an H3K27me3 mechanism. Interestingly, RNA sequencing of wound macrophages isolated from mice with JMJD3-deficient myeloid cells (Jmjd3f/fLyz2Cre+) identified that the STING gene (Tmem173) is regulated by JMJD3 in wound macrophages. STING limits inflammatory cytokine production by wound macrophages during healing. However, in diabetic mice, its role changes to limit wound repair and enhance inflammation. This finding is important since STING is associated with chronic inflammation, and we found STING to be elevated in human and murine diabetic wound macrophages at late time points. Finally, we demonstrate that macrophage-specific, nanoparticle inhibition of JMJD3 in diabetic wounds significantly improves diabetic wound repair by decreasing inflammatory cytokines and STING. Taken together, this work highlights the central role of JMJD3 in tissue repair and identifies cell-specific targeting as a viable therapeutic strategy for nonhealing diabetic wounds.

Updated research priorities of the Society for Vascular Surgery.

In 2011, the Society for Vascular Surgery (SVS) prepared a set of clinical research priorities through a survey of its membership. These priorities were developed with the goal of enhancing clinical research to improve care for vascular patients. In the subsequent decade, several of these priorities served as the focus of clinical trials and significant research efforts. It was understood from the outset that this list of priorities represented a starting point with the intention that they be reevaluated at suitable intervals. In 2021, the SVS Research Council set out to update the research priorities by surveying the SVS membership and engaged a panel of subject matter experts. This process resulted in an updated set of vascular research priorities that more clearly align with current areas of emphasis. Our priorities remain focused on basic areas including aortic disease, carotid disease, lower extremity arterial disease, venous disease, dialysis access, and medical management of vascular disease, along with the topic of health care disparities. The 10 updated priorities reported herein reflect our increasing awareness of the need to understand vascular disease pathogenesis and prevention in the context of a diverse patient population. Importantly, patient-centered outcomes and personalized vascular care are at the core of these updated priorities. Similar to the aims of the original 2011 clinical research priorities, our hope is that this updated list will help to drive large-scale investigations that will improve how we care for our vascular patients.

Use of an app-based exercise therapy program including cognitive-behavioral techniques for the management of intermittent claudication.

OBJECTIVE: Clinical practice guidelines recommend supervised exercise therapy (SET) as first-line therapy for patients with peripheral artery disease (PAD) and intermittent claudication (IC). The Society for Vascular Surgery Appropriate Use Criteria for IC deems excercise therapy (ET) as appropriate for all patients with IC. However, compliance with recommendations for the use of ET is often poor owing to the lack of availability, patient travel requirements, and cost. Results of home-based ET programs have been mixed with a trend toward improved results with more frequent patient engagement. The feasibility, use, and effectiveness of a 12-week app-based structured ET program using cognitive-behavioral therapy (CBT) techniques for IC was evaluated. METHODS: Patients with PAD confirmed by an abnormal ankle-brachial index or toe-brachial index and IC were recruited prospectively to participate in Society for Vascular Surgery SET, a 12-week app-based ET program. Participants performed home 6-minute walk tests, completed quality-of-life surveys, received education options via micro learning courses (eg, What is PAD?, Exercise, and Nutrition), and ongoing health coaching using CBT techniques. They were instructed to record at least three 30-minute ET walks a week using their personal mobile phones. Programming also included daily doses of health education, coaching, and reminders sent via text message. RESULTS: One hundred thirty-nine patients (37% women; mean age, 65 years) were enrolled across 20 institutions (44% offered in-person ET programs). One hundred twenty patients (86%) completed the program. Participants recorded 201,163 minutes of walking 8,013,520 steps with the ET program, completing a total of 5049 SET walks. Nineteen enrolled participants (14%) became inactive because they either paused (14 participants: medical reasons, travel, or other) or withdrew (5 participants: security concerns, lack of motivation). Ninety-two percent of patients met their stated CBT specific, measurable, achievable, relevant, and time-bound goals. Freedom from intervention at 6 months was 92% and 69% at 12 months. CONCLUSIONS: Deployment of a 12-week app-based ET program for PAD incorporating CBT was feasible in achieving 86% program completion and effective at meeting guideline recommended activity goals. Ninety-two percent of participants achieved their CBT specific, measurable, achievable, relevant, and time-bound goals. The use of ET was increased by virtue of offering this program at institutions that did not offer ET.

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.

Underutilization of medical management of peripheral artery disease among patients with claudication undergoing lower extremity bypass.

OBJECTIVE: First-line treatment of peripheral artery disease (PAD) involves medical therapy and lifestyle modification. Multiple professional organizations such as the Society for Vascular Surgery and the American Heart Association/American College of Cardiology make Class I recommendations for medical management including antiplatelet, statin, antihypertensive, and cilostazol medications, as well as lifestyle therapy including exercise and smoking cessation. Although evidence supports up-front medical and lifestyle management prior to surgical intervention, it is unclear how well this occurs in contemporary clinical practice. It is also unclear whether variability in first-line treatment prior to revascularization is associated with postoperative outcomes. This study examined the proportion of patients with claudication actively receiving evidence-based therapy prior to surgery in a statewide surgical registry. METHODS: We conducted a retrospective cohort study of adult patients undergoing elective open lower extremity bypass for claudication from 2012 to 2021 within a statewide surgical quality registry. The primary exposure was optimal medical therapy, defined as an antiplatelet agent, a statin, and an angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker (if the patient had hypertension) on the patient's home medication list on admission for surgery, all of which are Class I recommendations. Despite also being Class I recommendations, cilostazol was not included in the primary exposure due to its highly selective use and our inability to capture intolerance and/or contraindications that are common, and lifestyle therapies were not included as they were only recorded at the time of discharge rather than preoperatively. The primary outcomes were mortality, hospital readmission, amputation, wound complication, myocardial infarction (MI), non-patent bypass, and non-independent ambulatory status at 30 days and 1 year after surgery. Multivariable logistic regression was performed to estimate the association of receiving optimal vs non-optimal medical therapy. RESULTS: A total of 3829 patients with claudication underwent bypass surgery during the study period, with a mean age of 64.8 years (standard deviation, 9.8 years); 2690 (70.3%) were males, and 1873 (48.9%) were current smokers. Of the patients, 1822 (47.6%) were on optimal medical therapy prior to surgery. Additionally, at discharge, 66.5% of smokers received referral to smoking cessation therapy, and 54.1% of patients received referral to exercise therapy. In a multivariable logistic regression, compared with patients not on optimal medical therapy, patients on optimal medical therapy prior to surgery had lower 30-day odds of mortality (adjusted odds ratio [aOR], 0.45; 95% confidence interval [CI], 0.26-0.78) and MI (aOR, 0.46; 95% CI, 0.28-0.76), lower 1-year odds of mortality (aOR, 0.57; 95% CI, 0.39-0.82), MI (aOR, 0.48; 95% CI, 0.32-0.74), and lower readmission (aOR, 0.79; 95% CI, 0.64-0.96). CONCLUSIONS: Although medical and lifestyle management is recommended as first-line treatment for patients with PAD, only one-half of patients were on optimal medical therapy prior to surgery. Patients receiving optimal therapy had a lower risk of postoperative mortality, MI, and readmission. This suggests that not only are there significant opportunities to improve clinical utilization of evidence-based treatment of PAD, but that doing so can benefit patients postoperatively.

Claviculectomy for exposure and redo repair of expanding, recurrent right subclavian aneurysm.

Subclavian artery aneurysms (SAAs) are rare, and their repair can be technically complex. We have reported the redo repair of a large, expanding, right SAA after primary repair consisting of total aortic arch replacement with bilateral subclavian artery ligation and bypass. The redo repair used claviculectomy to facilitate exposure, ligation of the right deep cervical and internal thoracic arteries from within the aneurysm sac, and revision of the previous axillary artery bypass that had thrombosed owing to the mass effect of the expanding SAA. Claviculectomy can facilitate repair of large SAAs that are poorly suited to more routine exposure approaches, with acceptable risk and functional outcomes.

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.

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.