Infrapopliteal Endovascular Interventions for Claudication Are Associated with Poor Long-Term Outcomes in Medicare-Matched Registry Patients.

BACKGROUND: There are limited data supporting or opposing the use of infrapopliteal peripheral vascular interventions (PVI) for the treatment of claudication. OBJECTIVES: We aimed to evaluate the association of infrapopliteal PVI with long-term outcomes compared with isolated femoropopliteal PVI for the treatment of claudication. METHODS: We conducted a retrospective analysis of all patients in the Medicare-matched Vascular Quality Initiative database who underwent an index infrainguinal PVI for claudication from January 2004-December 2019 using Cox proportional hazards models. RESULTS: Of 14,261 patients (39.9% female; 85.6% age ≥65 years, 87.7% non-Hispanic white) who underwent an index infrainguinal PVI for claudication, 16.6% (N=2,369) received an infrapopliteal PVI. The median follow-up after index PVI was 3.7 years (IQR 2.1-6.1). Compared to patients who underwent isolated femoropopliteal PVI, patients receiving any infrapopliteal PVI had a higher 3-year cumulative incidence of conversion to CLTI (33.3% vs. 23.8%; P<0.001); repeat PVI (41.0% vs. 38.2%; P<0.01); and amputation (8.1% vs. 2.8%; P<0.001). After risk-adjustment, patients undergoing infrapopliteal PVI had a higher risk of conversion to CLTI (aHR 1.39, 95% CI, 1.25-1.53); repeat PVI (aHR 1.10, 95% CI, 1.01-1.19); and amputation (aHR 2.18, 95% CI, 1.77-2.67). Findings were consistent after adjusting for competing risk of death; in a 1:1 propensity-matched analysis; and in subgroup analyses stratified by TASC disease, diabetes, and end-stage kidney disease. CONCLUSIONS: Infrapopliteal PVI is associated with worse long-term outcomes than femoropopliteal PVI for claudication. These risks should be discussed with patients.

Decision aids for patients with carotid stenosis.

BACKGROUND: Shared decision-making tools have been underused by clinicians in real-world practice. Changes to the National Coverage Determination by Medicare for carotid stenting greatly expand the coverage for patients, but simultaneously require a shared decision-making interaction that involves the use of a validated tool. Accordingly, our objective was to evaluate the currently available decision aids for carotid stenosis. METHODS: We conducted a review of the literature for published work on decision aids for the treatment of carotid disease. RESULTS: Four publications met inclusion criteria. We found the format of the decision aid impacted patient comprehension and decision making, although patient characteristics also played a role in the therapeutic decisions made. Notably, none of the available decision aids included the widely adopted transcarotid artery revascularization as an option. CONCLUSIONS: Further work is needed in the development of a widespread validated decision aid instrument for patients with carotid stenosis.

Changes in global mortality from aortic aneurysm.

OBJECTIVE: Globally, there has been a marked increase in aortic aneurysm-related deaths between 1990 and 2019. We sought to understand the underlying etiologies for this mortality trend by examining secular changes in both demographics and the prevalence of risk factors, and how these changes may vary across sociodemographic index (SDI) regions. METHODS: We queried the Global Burden of Disease Study (GBD) for aortic aneurysm deaths from 1990 to 2019 overall and by age group. We identified the percentage of aortic aneurysm deaths attributable to each risk factor identified by GBD modeling (smoking, hypertension, lead exposure, and high sodium diet) and their respective changes over time. We then analyzed aneurysm mortality by SDI region. RESULTS: The number of aortic aneurysm-related deaths have increased from 94,968 in 1990 to 172,427 in 2019, signifying an 81.6% increase, which greatly exceeds the 18.2% increase in all-cause mortality observed over the same time interval. Examination of age-specific mortality demonstrated that the number of aortic aneurysm deaths markedly correlated with advancing age. However, when considering rate of death rather than mortality count, overall age-standardized death rates decreased 18% from 2.72 per 100,000 in 1990 to 2.21 per 100,000 in 2019. Analysis of the specific risk factors associated with aneurysm death revealed that the percentage of deaths attributable to smoking decreased from 45.6% in 1990 to 34.6% in 2019, and deaths attributable to hypertension decreased from 38.7% to 34.7%. Globally, hypertension surpassed smoking as the leading risk factor. The reported rate of death was consistently greater as SDI increased, and this effect was most pronounced among low-middle and middle SDI regions (173.2% and 170.4%, respectively). CONCLUSIONS: Despite an overall increase in the number of aneurysm deaths, there was a decrease in the age-standardized death rate, demonstrating that the observed increased number of aortic aneurysm deaths between 1990 and 2019 was primarily driven by an overall increase in the age of the global population. Fortunately, it appears that the increase in overall aneurysm-related deaths has been modulated by improved risk factor modification, in particular smoking. Given the rise in aneurysm-related deaths, global expansion of vascular specialty capabilities is warranted and will serve to amplify improvements in population-based aneurysm health achieved with risk factor control.

A patient-centered textbook outcome measure effectively discriminates contemporary elective open abdominal aortic aneurysm repair quality.

BACKGROUND: There is persistent controversy surrounding the merit of surgical volume benchmarks being used solely as a sufficient proxy for assessing the quality of open abdominal aortic aneurysm (AAA) repair. Importantly, operative volume quotas may fail to reflect a more nuanced and comprehensive depiction of surgical outcomes most relevant to patients. Accordingly, we herein propose a patient-centered textbook outcome (TO) for AAA repair that is analogous to other large magnitude extirpative operations performed in other surgical specialties, and test its feasibility to discriminate hospital performance using Society for Vascular Surgery (SVS) volume guidelines. METHODS: All elective open infrarenal AAA repairs (OAR) in the SVS-Vascular Quality Initiative were examined (2009-2022). The primary end point was a TO, defined as a composite of no in-hospital complication or reintervention/reoperation, length of stay of ≤10 days, home discharge, and 1-year survival rates. The discriminatory ability of the TO measure was assessed by comparing centers that did or did not meet the SVS annual OAR volume threshold recommendation (high volume ≥10 OARs/year; low volume <10 OARs/year). Logistic regression and multivariable models adjusted for patient and procedure-related differences. RESULTS: A total of 9657 OARs across 198 centers were analyzed (mean age, 69.5 ± 8.4 years; female, 26%; non-White, 12%). A TO was identified in 44% (n = 4293) of the overall cohort. The incidence of individual TO components included no in-hospital complication (61%), no in-hospital reintervention or reoperation (92%), length of stay of ≤10 days (78%), home discharge (76%), and 1-year survival (91%). Median annual center volume was 6 (interquartile range, 3-10) and a majority of centers did not meet the SVS volume suggested threshold (<10 OARs/year, n = 148 [74%]). However, most patients (6265 of 9657 [65%]) underwent OAR in high-volume hospitals. When comparing high- and low-volume centers, a TO was more likely to occur in high-volume institutions: ≥10 OARs/year (46%) vs <10 OARs/year (42%; P = .0006). The association of a protective effect for higher center volume remained after risk adjustment (odds ratio, 1.1; 95% confidence interval, 1.05-1.26; P = .003). CONCLUSIONS: TOs for elective OAR reflect a more nuanced and comprehensive patient centered proxy to measure care delivery, consistent with other surgical specialties. Surprisingly, a TO was achieved in <50% of elective AAA cases nationally. Although the likelihood of a TO seems to correlate with SVS center volume recommendations, it more importantly reflects elements which may be prioritized by patients and thus offers insights into further improving real-world AAA care.

Patient decision-making in the era of transcarotid artery revascularization.

OBJECTIVE: The National Coverage Determination on carotid stenting by Medicare in October 2023 stipulates that patients participate in a shared decision-making (SDM) conversation with their proceduralist before an intervention. However, to date, there is no validated SDM tool that incorporates transcarotid artery revascularization (TCAR) into its decision platform. Our objective was to elicit patient and surgeon experiences and preferences through a qualitative approach to better inform the SDM process surrounding carotid revascularization. METHODS: We performed longitudinal perioperative semistructured interviews of 20 participants using purposive maximum variation sampling, a qualitative technique designed for identification and selection of information-rich cases, to define domains important to participants undergoing carotid endarterectomy or TCAR and impressions of SDM. We also performed interviews with nine vascular surgeons to elicit their input on the SDM process surrounding carotid revascularization. Interview data were coded and analyzed using inductive content analysis coding. RESULTS: We identified three important domains that contribute to the participants' ultimate decision on which procedure to choose: their individual values, their understanding of the disease and each procedure, and how they prefer to make medical decisions. Participant values included themes such as success rates, "wanting to feel better," and the proceduralist's experience. Participants varied in their desired degree of understanding of carotid disease, but all individuals wished to discuss each option with their proceduralist. Participants' desired medical decision-making style varied on a spectrum from complete autonomy to wanting the proceduralist to make the decision for them. Participants who preferred carotid endarterectomy felt outcomes were superior to TCAR and often expressed a desire to eliminate the carotid plaque. Those selecting TCAR felt it was a newer, less invasive option with the shortest procedural and recovery times. Surgeons frequently noted patient factors such as age and anatomy, as well as the availability of long-term data, as reasons to preferentially select one procedure. For most participants, their surgeon was viewed as the most important source of information surrounding their disease and procedure. CONCLUSIONS: SDM surrounding carotid revascularization is nuanced and marked by variation in patient preferences surrounding autonomy when choosing treatment. Given the mandate by Medicare to participate in a SDM interaction before carotid stenting, this analysis offers critical insights that can help to guide an efficient and effective dialog between patients and providers to arrive at a shared decision surrounding therapeutic intervention for patients with carotid disease.

Size thresholds for repair of abdominal aortic aneurysms warrant reconsideration.

BACKGROUND: The historical size threshold for abdominal aortic aneurysm (AAA) repair is widely accepted to be 5.5 cm for men and 5.0 cm for women. However, contemporary AAA rupture risks may be lower than historical benchmarks, which has implications for when AAAs should be repaired. Our objective was to use contemporary AAA rupture rates to inform optimal size thresholds for AAA repair. METHODS: We used a Markov chain analysis to estimate life expectancy for patients with AAA. The primary outcome was AAA-related mortality. We estimated survival using Social Security Administration life tables and published contemporary AAA rupture estimates. For those undergoing repair, we modified survival estimates using data from the Vascular Quality Initiative and Medicare on complications, late rupture, and open conversion. We used this model to estimate the AAA repair size threshold that minimizes AAA-related mortality for 60-year-old average-health men and women. We performed a sensitivity analysis of poor-health patients and 70- and 80-year-old base cases. RESULTS: The annual risk of all-cause mortality under surveillance for a 60-year-old woman presenting with a 5.0 cm AAA using repair thresholds of 5.5 cm, 6.0 cm, 6.5 cm, and 7.0 cm was 1.7%, 2.3%, 2.7%, and 2.8%, respectively. The corresponding risk for a man was 2.3%, 2.9%, 3.3%, and 3.4% for the same repair thresholds, respectively. For a 60-year-old average-health woman, an AAA repair size of 6.1 cm was the optimal threshold to minimize AAA-related mortality. Life expectancy varied by <2 months for repair at sizes from 5.7 cm to 7.1 cm. For a 60-year-old average-health man, an AAA repair size of 6.9 cm was the optimal threshold to minimize AAA-related mortality. Life expectancy varied by <2 months for repair at sizes from 6.0 cm to 7.4 cm. Women in poor health, at various age strata, had optimal AAA repair size thresholds that were >6.5 cm, whereas men in poor health, at all ages, had optimal repair size thresholds that were >8.0 cm. CONCLUSIONS: The optimal threshold for AAA repair is more nuanced than a discrete size. Specifically, there appears to be a range of AAA sizes for which repair is reasonable to minmized AAA-related mortality. Notably, they all are greater than current guideline recommendations. These findings would suggest that contemporary AAA size thresholds for repair should be reconsidered.

A Retrospective Analysis of Surgical Acuity & Procedure Volume Before & During the COVID-19 Pandemic.

INTRODUCTION: In March 2020, the American College of Surgeons recommended postponing elective procedures amid the COVID-19 pandemic. We used Medicare claims to analyze changes in surgical and interventional procedure volumes from 2016 to 2021. METHODS: We studied 37 common surgical and interventional procedures using 5% Medicare claims files from January 1, 2016, through December 31, 2021. Procedures were classified according to American College of Surgeons guidelines as low, intermediate, or high acuity, and counts were analyzed per calendar year quarter (Q1-Q4), with stratification by sex and race/ethnicity. RESULTS: We observed 1,840,577 procedures and identified two periods of marked decline. In Q2 2020, overall procedure counts decreased by 32.2%, with larger declines in low (41.1%) and intermediate (30.8%) acuity procedures. High acuity procedures declined the least (18.2%). Overall volumes increased afterward but never returned to baseline. Another marked decline occurred in Q4 2021, with all acuity levels having declined to a similar extent (40.1%, 44.2%, and 46.9% for low, intermediate, and high acuity, respectively). High and intermediate acuity procedures declined more in Q4 2021 than Q2 2020 (P = 0.002). Similar patterns were observed across sex and race/ethnicity strata. CONCLUSIONS: Two major procedural volume declines occurred between 2020 and 2022 during the COVID-19 pandemic in the United States. High acuity (life or limb threatening) procedures were least affected in the first decline (Q2 2020) but not spared in second decline (Q4 2021). Future efforts should prioritize preserving high-acuity access during times of stress.

Most preoperative stress tests fail to comply with practice guideline indications and do not reduce cardiac events.

BACKGROUND: There is wide variation in stress test utilization before major vascular surgery and adherence to practice guidelines is unclear. We defined rates of stress test compliance at our institution and led a quality improvement initiative to improve compliance with American Heart Association (ACC/AHA) guidelines. METHODS: We implemented a stress testing order set in the electronic medical record at one tertiary hospital. We reviewed all patients who underwent elective, major vascular surgery in the 6 months before (Jan 1, 2022 - Jul 1, 2022) and 6 months after (Aug 1, 2022 - Jan 31, 2023) implementation. We studied stress test guideline compliance, changes in medical or surgical management, and major adverse cardiac events (MACE). RESULTS: Before order set implementation, 37/122 patients (30%) underwent stress testing within the past year (29 specifically ordered preoperatively) with 66% (19/29) guideline compliance. After order set implementation, 50/173 patients (29%) underwent stress testing within the past year (41 specifically ordered preoperatively) with 80% (33/41) guideline compliance. In the pre- and postimplementation cohorts, stress testing led to a cardiovascular medication change or preoperative coronary revascularization in 24% (7/29) and 27% (11/41) of patients, and a staged surgery or less invasive anesthetic strategy in 14% (4/29) and 4.9% (2/41) of patients, respectively. All unindicated stress tests were surgeon-ordered and none led to a change in management. There was no change in MACE after order set implementation. CONCLUSIONS: Electronic medical record-based guidance of perioperative stress testing led to a slight decrease in overall stress testing and an increase in guideline-compliant testing. Our study highlights a need for improved preoperative cardiovascular risk assessment prior to major vascular surgery, which may eliminate unnecessary testing and more effectively guide perioperative decision-making.

The impact of the Affordable Care Act Medicaid Expansion in Medicare beneficiaries with peripheral artery disease.

Background: In 2014, the Affordable Care Act Medicaid Expansion (ME) increased Medicaid eligibility for adults with an income level up to 138% of the federal poverty level. In this study, we examined the impact of ME on mortality and amputation in patients with peripheral artery disease (PAD). Methods: The 100% MedPAR and Part-B Carrier files from 2011 to 2018 were queried to identify all fee-for-service Medicare beneficiaries with PAD using International Classification of Diseases codes. Our primary exposure was whether a state had adopted the ME on January 1, 2014. Our primary outcomes were the change in all-cause 1-year mortality and leg amputation. We used a state-level difference-in-differences (DID) analysis to compare the rates of the primary outcomes among patients who were in states (including the District of Columbia) who adopted ME (n = 25) versus those who were in states that did not (n = 26). We performed a subanalysis stratifying by sex, race, region, and dual-eligibility status. Results: Over the 8-year period, we studied 37,743,929 patients. The average unadjusted 1-year mortality decreased from 2011 to 2018 in both non-ME (9.5% to 8.7%, p < 0.001) and ME (9.1% to 8.3%, p < 0.001) states. The average unadjusted 1-year amputation rate did not improve in either the non-ME (0.86% to 0.87%, p = 0.17) or ME (0.69% to 0.69%, p = 0.65) states. Across the entire cohort, the DID model revealed that ME did not lead to a significant change in mortality (p = 0.15) or amputation (p = 0.34). Conclusion: Medicaid Expansion was not associated with reduced mortality or leg amputation in Medicare beneficiaries with PAD.

The Sustained Impact of the COVID-19 Pandemic on Vascular Surgical Care Delivery.

OBJECTIVE: The COVID-19 pandemic necessitated postponement of vascular surgery procedures nationally. Whether procedure volumes have since recovered remains undefined. Therefore, our objective was to quantify changes in procedure volumes and determine whether surgical volume has returned to its pre-pandemic baseline. METHODS: This study was a retrospective cross-sectional study between 2018 and 2023 utilizing the US Fee-for-Service Medicare 5% National Sample as part of the VA Disrupted Care National Project. We studied patients who underwent one of three procedures: abdominal aortic aneurysm (AAA) repair for intact aneurysms, carotid endarterectomy (CEA), and major lower extremity amputation (LEA). The case volume of each quarter of 2020-2023 was compared to its corresponding pre-pandemic quarter in 2019. We then performed a sub-analysis of these trends by sex, age, and race. RESULTS: We identified 21,031 procedures: 4,411 AAA repair, 8,361 CEA, and 8,259 LEA. The average percent change during the baseline pre-pandemic period from 2018 to 2019 was -4.3% for AAA repair, -8.5% for CEA, and -2.6% for LEA. Compared to Q2 of 2019, Q2 of 2020 demonstrated that AAA repair procedures decreased by 47%, CEA by 40%, and LEA by 14%. While procedures initially rebounded in Q3 of 2020, volumes did not return to their pre-pandemic baseline, demonstrating a persistent volume reduction (-16% AAA, -22% CEA, and -11% LEA). Thereafter, procedure counts again declined in Q1 of 2022 (-25% AAA, -34% CEA, and -25% LEA). CONCLUSIONS: Despite a perception that vascular surgical care was singularly disrupted at the outset of the pandemic, there has been a sustained reduction in vascular surgical volume since 2019. Not only have procedure volumes not returned to pre-pandemic baseline, but it also appears that there has been a cumulative incremental impact on overall procedure volume. The impact of these findings on long term population health remain uncertain and necessitate a better understanding of post-pandemic care delivery.

Increased Preoperative Stress Test Utilization is Not Associated With Reduced Adverse Cardiac Events in Current US Surgical Practice.

OBJECTIVE: To measure the frequency of preoperative stress testing and its association with perioperative cardiac events. BACKGROUND: There is persistent variation in preoperative stress testing across the United States. It remains unclear whether more testing is associated with reduced perioperative cardiac events. METHODS: We used the Vizient Clinical Data Base to study patients who underwent 1 of 8 elective major surgical procedures (general, vascular, or oncologic) from 2015 to 2019. We grouped centers into quintiles by frequency of stress test use. We computed a modified revised cardiac risk index (mRCRI) score for included patients. Outcomes included in-hospital major adverse cardiac events (MACEs), myocardial infarction (MI), and cost, which we compared across quintiles of stress test use. RESULTS: We identified 185,612 patients from 133 centers. The mean age was 61.7 (±14.2) years, 47.5% were female, and 79.4% were White. Stress testing was performed in 9.2% of patients undergoing surgery, and varied from 1.7% at lowest quintile centers, to 22.5% at highest quintile centers, despite similar mRCRI comorbidity scores (mRCRI>1: 15.0% vs 15.8%; P =0.068). In-hospital MACE was less frequent among lowest versus highest quintile centers (8.2% vs 9.4%; P <0.001) despite a 13-fold difference in stress test use. Event rates were similar for MI (0.5% vs 0.5%; P =0.737). Mean added cost for stress testing per 1000 patients who underwent surgery was $26,996 at lowest quintile centers versus $357,300 at highest quintile centers. CONCLUSIONS: There is substantial variation in preoperative stress testing across the United States despite similar patient risk profiles. Increased testing was not associated with reduced perioperative MACE or MI. These data suggest that more selective stress testing may be an opportunity for cost savings through a reduction of unnecessary tests.

The financial burden associated with endovascular repair of thoracoabdominal and pararenal aortic aneurysms using physician-modified fenestrated-branched endografts.

OBJECTIVE/BACKGROUND: Endovascular thoracoabdominal and pararenal aortic aneurysm repair is more complex and requires more devices than infrarenal aneurysm repair. It is unclear if current reimbursement covers the cost of delivering this more advanced form of vascular care. The objective of this study was to evaluate the economics of fenestrated-branched (FB-EVAR) physician-modified endograft (PMEG) repairs. METHODS: We obtained technical and professional cost and revenue data for four consecutive fiscal years (July 1, 2017, to June 30, 2021) at our quaternary referral institution. Inclusion criteria were patients who underwent PMEG FB-EVAR in a uniform fashion by a single surgeon for thoracoabdominal/pararenal aortic aneurysms. Patients in industry-sponsored clinical trials or receiving Cook Zenith Fenestrated grafts were excluded. Financial data were analyzed for the index operation. Technical costs were divided into direct costs that included devices and billable supplies and indirect costs including overhead. RESULTS: 62 patients (79% male, mean age: 74 years, 66% thoracoabdominal aneurysms) met inclusion criteria. The mean aneurysm size was 6.0 cm, the mean total operating time was 219 minutes, and the median hospital length of stay was 2 days. PMEGs were created with a mean number of 3.7 fenestrations, using a mean of 8.6 implantable devices per case. The average technical cost per case was $71,198, and the average technical reimbursement was $57,642, providing a net negative technical margin of $13,556 per case. Of this cohort, 31 patients (50%) were insured by Medicare remunerated under diagnosis-related group code 268/269. Their respective average technical reimbursement was $41,293, with a mean negative margin of $22,989 per case, with similar findings for professional costs. The primary driver of technical cost was implantable devices, accounting for 77% of total technical cost per case over the study period. The total operating margin, including technical and professional cost and revenue, for the cohort during the study period was negative $1,560,422. CONCLUSIONS: PMEG FB-EVAR for pararenal/thoracoabdominal aortic aneurysms produces a substantially negative operating margin for the index operation driven largely by device costs. Device cost alone already exceeds total technical revenue and presents an opportunity for cost reduction. In addition, increased reimbursement for FB-EVAR, especially among Medicare beneficiaries, will be important to facilitate patient access to such innovative technology.

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

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

The global burden of peripheral artery disease.

BACKGROUND: Previous efforts to characterize the burden of peripheral artery disease (PAD) have focused on national populations. A need for a more detailed analysis of how PAD impacts the global population has been identified. Our objective was to study in greater detail the global burden of PAD, including its impact on mortality, over the past three decades. METHODS: Using data and models from the Global Burden of Diseases, Injuries and Risk Factors Study, we estimated the prevalence, years of life lost, years lived with disability and disability-adjusted life-years (a measure accounting for incurred morbidity and mortality), attributable to PAD. We analyzed results over time and stratified by sex, age, and sociodemographic index (SDI) group. We compared PAD with other atherosclerosis-related conditions and assessed the contribution of risk factors to PAD disability-adjusted life-years. RESULTS: We observed a 72% increase in the global prevalence of PAD from an estimated 65,764,499 persons in 1990 to 113,443,016 in 2019. Prevalence per 100,000 persons increased 13% and the prevalence per 100,000 age-standardized decreased 22%. Similar patterns were seen for years of live lost, mortality, years lived with disability, and disability-adjusted life-years. The prevalence and disability were higher among women, whereas mortality and years of life lost were higher among men. Disease burden increased with increasing SDI. These increases in PAD were in contrast with global trends for the overall burden of ischemic heart disease and ischemic stroke, which had decreasing prevalence and disease-related mortality over the same time frame. Overall, only approximately 55% of PAD disease burden could be attributed to identified risk factors, with tobacco use, diabetes, and hypertension being the three major contributors in all SDI groups. CONCLUSIONS: The global prevalence and mortality associated with PAD has increased substantially, in contrast with other forms of ischemic cardiovascular disease. Globally, there is a growing need for vascular surgical resources to manage PAD, as well as public health efforts to address risk factors for this increasing health threat.

The Contemporary Impact of Body Mass Index on Open Aortic Aneurysm Repair.

INTRODUCTION: The Centers for Disease Control and Prevention (CDC) has deemed obesity a national epidemic and contributor to other leading causes of death including heart disease, stroke, and diabetes. Accordingly, the role of body mass index (BMI) and its impact on surgical outcomes has been a focus of persistent investigation. The purpose of this study was to quantify the effect of BMI on open abdominal aortic aneurysm repair (oAAA) outcomes in contemporary practice. METHODS: All elective oAAAs in the VQI (2010-2021) were identified. End-points included 30-day death, in-hospital complications and 1-year mortality. Patients were stratified into four BMI cohorts (BMI<18.5, 18.5≤BMI<25, 25≤BMI<30, BMI≥30). Spline interpolation was used to explore a potential non-linear association between BMI and perioperative mortality. Mixed-effects Cox regression was used to assess the association between BMI and 1-year survival. RESULTS: 9,479 patients underwent oAAA over the study interval (median age-70, 74%-male, BMI 27±6). Lower BMI patients(<18.5) compared to higher BMI(>30) patients were more likely to be women (53% vs. 32%;p<.0001), current smokers(65% vs. 50%;p<.0001), and have COPD(58% vs. 37%;p<.0001). In contrast, an increased BMI was associated with a greater prevalence of diabetes and CAD (DM-26% vs. 6%;p<.0001; CAD-27% vs. 20%;p=.01). There was no difference in cross-clamp position or visceral/renal bypass between groups, though low BMI patients necessitated more frequent infrainguinal bypass(5% vs. 2%;p=.0002). 30-day mortality and in-hospital complications were greater among low BMI patients(30-day mortality:12% vs. 4%;p<.0001;complications-47% vs. 37%;p<.0001). Interestingly, low BMI conferred a nearly 2-fold increase in observed pulmonary complications(18% vs. 11%;p<.0001). Surgical site infections were twice as common among the lowest and highest BMI groups(4% vs. 2%;p<.0001). 1-year mortality was greatest among low BMI patients(23% vs. 9%;p<.0001). Adjusted spline-fit analysis demonstrated increased mortality among patients with BMI<21 or >34(BMI<18.5-HR 2.1, 95%CI 1.6-2.8;p<.0001; BMI>34-HR 1.3, 95%CI 1.1-1.6;p=.009). CONCLUSION: Both low (<18.5) and high (>34) BMI were associated with increased oAAA mortality in current practice. Despite the perception that obesity confers substantial surgical risk during oAAA, diminished BMI was associated with a 3-fold increase in 30-day and 1-year mortality. It appears that BMI extremes are distinct proxies for differential clinical phenotypes and should inform risk stratification for oAAA repair.

Market competition influences practice patterns in management of patients with intermittent claudication in the vascular quality initiative.

OBJECTIVE: The Society for Vascular Surgery (SVS) clinical practice guidelines recommend best medical therapy (BMT) as first-line therapy before offering revascularization to patients with intermittent claudication (IC). Notably, atherectomy and tibial-level interventions are generally discouraged for management of IC; however, high regional market competition may incentivize physicians to treat patients outside the scope of guideline-directed therapy. Therefore, we sought to determine the association between regional market competition and endovascular treatment of patients with IC. METHODS: We examined patients with IC undergoing index endovascular peripheral vascular interventions (PVI) in the SVS Vascular Quality Initiative from 2010 to 2022. We assigned the Herfindahl-Hirschman Index as a measure of regional market competition and stratified centers into very high competition (VHC), high competition, moderate competition, and low competition cohorts. We defined BMT as preoperative documentation of being on antiplatelet medication, statin, nonsmoking status, and a recorded ankle-brachial index. We used logistic regression to evaluate the association of market competition with patient and procedural characteristics. A sensitivity analysis was performed in patients with isolated femoropopliteal disease matched by the TransAtlantic InterSociety classification of disease severity. RESULTS: There were 24,669 PVIs that met the inclusion criteria. Patients with IC undergoing PVI were more likely to be on BMT when treated in higher market competition centers (odds ratio [OR], 1.07 per increase in competition quartile; 95% confidence interval [CI], 1.04-1.11; P < .0001). The probability of undergoing aortoiliac interventions decreased with increasing competition (OR, 0.84; 95% CI, 0.81-0.87; P < .0001), but there were higher odds of receiving tibial (OR, 1.40; 95% CI, 1.30-1.50; P < .0001) and multilevel interventions in VHC vs low competition centers (femoral + tibial OR, 1.10; 95% CI, 1.03-1.14; P = .001). Stenting decreased as competition increased (OR, 0.89; 95% CI, 0.87-0.92; P < .0001), whereas exposure to atherectomy increased with higher market competition (OR, 1.15; 95% CI, 1.11-1.19; P < .0001). When assessing patients undergoing single-artery femoropopliteal intervention for TransAtlantic InterSociety A or B lesions to account for disease severity, the odds of undergoing either balloon angioplasty (OR, 0.72; 95% CI, 0.625-0.840; P < .0001) or stenting only (OR, 0.84; 95% CI, 0.727-0.966; P < .0001) were lower in VHC centers. Similarly, the likelihood of receiving atherectomy remained significantly higher in VHC centers (OR, 1.6; 95% CI, 1.36-1.84; P < .0001). CONCLUSIONS: High market competition was associated with more procedures among patients with claudication that are not consistent with guideline-directed therapy per the SVS clinical practice guidelines, including atherectomy and tibial-level interventions. This analysis demonstrates the susceptibility of care delivery to regional market competition and signifies a novel and undefined driver of PVI variation among patients with claudication.

Readmission After Lower Extremity Bypass Following Discharge to a Rehabilitation or Nursing Facility.

INTRODUCTION: Hospital readmission after lower extremity arterial bypass (LEB) is common. Patients are often discharged to a facility after LEB as a bridge to home. Our objective was to define the association between discharge to a facility and readmission after LEB. METHODS: We used the Vascular Quality Initiative to study patients who underwent LEB from 2017 to 2022. The primary exposure was discharge location. The primary outcome was 30-d hospital readmission. RESULTS: We included 6076 patients across 147 centers. The overall 30-d readmission rate was 18%. Readmission occurred among 15% of patients discharged home, 22% of patients discharged to a rehabilitation facility, and 25% of patients discharged to a nursing home. After controlling for patient and procedural factors, there was no significant association between discharge location and 30-d readmission (rehabilitation versus home odds ratio: 1.06, 95% confidence interval: 0.87-1.29; nursing facility versus home odds ratio: 1.21, 95% confidence interval: 0.99-1.47). Female sex, end-stage renal disease, diabetes, heart failure, pulmonary disease, smoking, preoperative functional impairment, tibial bypass target, critical limb threatening or acute ischemia, and postoperative complications including surgical site infection, change in renal function and graft thrombosis were associated with an increased likelihood of readmission. CONCLUSIONS: Patients discharged home after LEB experienced a similar likelihood of readmission as those discharged to a facility. While discharge to a facility may aid in care transitions, it did not appear to lead to reduced 30-d readmissions. The recommended discharge location should be predicated on patient care needs and not as a perceived mechanism to reduce readmissions.

Validation of an indirect linkage algorithm to combine registry data with Medicare claims.

BACKGROUND: The linkage of registries to Medicare claims data can help extend follow-up for patients receiving medical devices. In the present study, we tested and validated an algorithm that does not require patient identifiers to link data from a national vascular registry and Medicare claims data. METHODS: We used data from the Vascular Quality Initiative (VQI), a registry capturing data from >600 centers for several different vascular procedures, and Medicare claims from 2003 to 2018. We restricted the study to patients aged ≥65 years who had fee-for-service entitlement at their procedure. We performed an indirect linkage to combine the VQI and Medicare data at the patient level using a sequential algorithm based on the patient's date of birth, sex, zip code, procedure date, and procedure facility. We compared the indirectly linked cohort against a reference standard of a cohort directly linked using Social Security numbers. We calculated the matching rate and accuracy overall and before and after October 2015 when the International Classification of Diseases, 10th revision (ICD-10) system was adopted in the United States. RESULTS: A total of 144,045 VQI-Medicare-linked patients were in the reference standard cohort. Using the indirect linking algorithm, we matched 133,966 of the 144,045 VQI patients to their Medicare claims with a matching rate of 93.0%. Of the 133,966 patients, 133,104 were correctly matched (matching accuracy, 99.4%). The matching rate was higher when the indirect linkage was implemented using the ICD-10 coded data than using the ICD-9 coded data (94.0% vs 92.2%). The accuracy of the indirect linkage remained high for all procedure modules after the ICD-10 coding change (overall, 99.4%; range, 99.0%-99.7%). CONCLUSIONS: In the present study, we successfully used indirect identifiers to link the VQI data to Medicare claims with >90% success and >99% accuracy. When direct linkage of the registry claims data using Social Security numbers is not possible because of availability or confidentiality, or both, our algorithm for indirect linkage provides a suitable alternative. The matching rate and accuracy will help ensure the accuracy of long-term follow-up and the completeness and representativeness of linked databases for relevant research and quality improvement initiatives.

Non-guideline-compliant endovascular abdominal aortic aneurysm repair in women is associated with increased mortality and reintervention compared with men.

OBJECTIVE: Sex-based disparities in surgical outcomes have emerged as an important focus in contemporary healthcare delivery. Likewise, the appropriate usage of endovascular abdominal aortic aneurysm repair (EVAR) in the United States remains a subject of ongoing controversy, with a significant number of U.S. EVARs failing to adhere to the Society for Vascular Surgery (SVS) clinical practice guideline (CPG) diameter thresholds. The purpose of the present study was to determine the effect of sex among patients undergoing EVAR that was not compliant with the SVS CPGs. METHODS: All elective EVAR procedures for abdominal aortic aneurysms without a concomitant iliac aneurysm (≥3.0 cm) in the SVS Vascular Quality Initiative were analyzed (2015-2019; n = 25,112). SVS CPG noncompliant repairs were defined as a size of <5.5 cm for men and <5.0 cm for women. The primary endpoint was 30-day mortality. The secondary endpoints were all-cause mortality, complications, and reintervention. Logistic regression was performed to control for surgeon- and patient-level factors. Freedom from the endpoints was determined using the Kaplan-Meier method. RESULTS: Noncompliant EVAR was performed in 9675 patients (38.5%). Although men were significantly more likely to undergo such procedures (90% vs 10%; odds ratio [OR], 3.1; 95% confidence interval [CI], 2.9-3.4; P < .0001), the 30-day mortality was greater for the women than the men (1.8% vs 0.5%; P = .0003). Women also experienced significantly higher rates of multiple complications, including postoperative myocardial infarction (1% vs 0.3%; P = .006), respiratory failure (1.4% vs 0.6%; P = .01), intestinal ischemia (0.7% vs 0.2%; P = .003), access vessel hematoma (3% vs 1.2%; P = .0006), and iliac access vessel injury (2.4% vs 0.8%; P < .0001). Additionally, women experienced increased overall 1-year reintervention rates (11.5% vs 5.8%; P < .0001). In the adjusted analysis, 30-day mortality and any in-hospital complication risk remained significantly greater for the women (30-day death: OR, 3.1; 95% CI, 1.6-5.8; P = .0005; in-hospital complication: OR, 1.9; 95% CI, 1.4-2.6; P < .0001). Women also experienced increased reintervention rates over time compared with men (OR, 1.5; 95% CI, 1.1-2.2; P = .02). CONCLUSIONS: Although men were more likely to undergo non-CPG compliant EVAR, women experienced increased short-term morbidity and 30-day mortality and higher rates of reintervention when undergoing non-CPG compliant EVAR. These unanticipated findings necessitate increased scrutiny of current U.S. sex-based EVAR practice and should caution against the use of non-CPG compliant EVAR for women.

Center volume is associated with diminished failure to rescue and improved outcomes following elective open abdominal aortic aneurysm repair.

OBJECTIVE: Conflicting annual procedure volumes have been endorsed among different watchdog groups and professional societies, obscuring credentialing paradigms. There has been ample focus on surgeon volume to date but less attention on the effect of center volume. Specifically, whether center volume might be a better proxy for high-quality care. In the present study, we aimed to measure the association of center volume on open abdominal aortic aneurysm (AAA) repair (OAR) outcomes and failure to rescue (FTR). METHODS: All elective OARs (2003-2020) in the Society for Vascular Surgery Vascular Quality Initiative were reviewed (n = 9791). FTR was defined as in-hospital death after the occurrence of a complication (ie, cardiac, stroke, pulmonary, renal, colonic ischemia, return to the operating room for bleeding). The annual center volume for 218 hospitals was calculated, and the volume quartiles (quartile 1 [Q1], ≤3 procedures/y; quartile 2 [Q2], 4-6 procedures/y; quartile 3 [Q3], 7-10 procedures/y; quartile 4 [Q4], >10 procedures/y) were derived for comparison. Logistic regression was used to estimate the effect of center volume and determine the predictors of FTR. RESULTS: The center volume quartiles and incidence of FTR varied significantly (Q4, 2.5% vs Q1 and Q2, 4.9%; P < .0001; overall FTR, 3.1% [n = 302]). The patients were demographically similar among the quartiles. High-volume centers had used epidural anesthesia more often (Q4, 53%; vs Q1, 31%; P < .0001) but were less likely to use thrombectomy (Q4, 5%; vs Q1, 10%; P < .0001) or any concomitant procedure (Q4, 19%; vs Q1, 22%; P = .05). High-volume centers had had lower rates of pulmonary, renal, and overall complications (pulmonary: Q4, 7%; vs Q1-Q2, 8%-11%; renal: Q4, 16%; vs Q1-2, 19%-21%; P < .0001; overall mean number of complications: Q4, 0.46; vs Q1, 0.52; P = .0008). The crude 30-day and 1-year mortality rates were reduced at the higher volume centers (30 days: Q4, 3%; vs Q1-Q2, 6%; P < .0001; 1 year: Q4, 7%; vs Q1-Q2, 10%-11%; P < .0001). A strong inverse relationship between center volume and FTR was identified (P < .0001). In the adjusted analysis, OARs performed in high-volume centers (Q4 vs Q1) had a 50% risk reduction in FTR (odds ratio [OR], 0.48; 95% confidence interval [CI], 0.3-0.8; P = .004). Among the complications, a return to the operating room for bleeding was most likely to result in FTR (OR, 11.8; 95% CI, 4.3-33; P < .0001). A 24-fold increased risk of FTR was found for patients experiencing three or more complications vs one complication (OR, 24; 95% CI, 17-35; P < .0001). CONCLUSIONS: A greater center volume was strongly associated with significantly diminished FTR, reduced complications, and need for surgical adjuncts during OAR. These findings highlight the utility of center volume as an effective proxy to ensure high-quality aneurysm care.