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.

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.

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.

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.

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 financial implications of cardiac stress testing prior to abdominal aortic aneurysm repair.

BACKGROUND: The utilization and cost-effectiveness of stress testing before abdominal aortic aneurysm (AAA) repair remains insufficiently studied. We examined the variation and financial implications of stress testing, and their association with major adverse cardiovascular events (MACE). METHODS: We studied patients who underwent elective endovascular (EVAR) or open AAA repair (OAR) at Vascular Quality Initiative centers from 2015 to 2019. We grouped centers into quintiles of preoperative stress testing frequency. We calculated the risk of postoperative MACE, a composite of in-hospital myocardial infarction, heart failure, or death, for each center-quintile. We obtained charges for stress tests locally and applied these to the cohort to estimate charges per 1000 patients. RESULTS: We studied 32,459 patients (EVAR: 27,978; OAR: 4481; 283 centers). Stress test utilization varied across quintiles from 13.0% to 68.6% (median: 36.8%) before EVAR and 15.9% to 85.0% (median: 59.4%) before OAR. The risk of MACE was 1.4% after EVAR and 10.2% after OAR. There was a trend towards more common MACE after EVAR among centers with higher utilization of stress testing: 0.9% among centers in the lowest quintile, versus 1.7% in the highest quintile (p-trend = 0.068). There was no association between MACE and stress testing frequency for OAR (p-trend = 0.223). The estimated financial charges for stress testing before EVAR ranged from $125,806 per 1000 patients at 1st-quintile centers, to $665,975 at 5th-quintile centers. Charges before OAR ranged from $153,861 at 1st-quintile centers, to $825,473 at 5th-quintile centers. CONCLUSION: Stress test use before AAA repair is highly variable and associated with substantial cost, with an unclear association with postoperative MACE. This highlights the need for improved stress testing paradigms prior to surgery.

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.

Procedure-Associated Costs and Mid-Term Outcomes of Endovascular Zone 0 and Zone 1 Aortic Arch Repair.

BACKGROUND: Thoracic endovascular aortic repair (TEVAR) of proximal aortic arch pathology provides a less-invasive treatment option for high-risk patients ineligible for open arch reconstruction. However, the fiscal impact of these techniques remains unclear. Therefore, our objective was to characterize the mid-term outcomes after Zone 0 and Zone 1 TEVAR and describe the associated technical costs, revenues, and net margins at a single tertiary medical center. METHODS: We examined all patients who underwent TEVAR between April 2011 and August 2019 via retrospective chart review. Patients were categorized by proximal endograft extent to identify Zone 0 or Zone 1 repairs. Procedural characteristics and outcomes were described. Technical costs, revenues, and margins were obtained from the hospital finance department. RESULTS: We identified 10 patients (6 Zone 0, 4 Zone 1) who were denied open arch reconstruction. Patients were predominantly female (n = 8; 80%) and the mean age was 72.8 ± 5.5 years. TEVAR was performed in 5 asymptomatic patients, urgently in 3 symptomatic patients, and emergently in 2 ruptured patients. TEVAR plus extra-anatomic bypass was performed in 4 patients. Another 4 patients also received parallel stent-grafting while 1 patient received a branched thoracic endograft and yet another an in-situ laser fenestration followed by branch stent grafting. Within the 30-day postoperative period, 1 patient experienced stroke and 1 patient died. Bypass and branch vessel patency were 100% through the duration of follow-up (mean 19.3 months). Mean total technical cost associated with all procedures or repair stages was $105,164 ± $59,338 while mean net technical margin was -$25,055 ± $18,746. The net technical margin was negative for 9 patients. CONCLUSIONS: Endovascular repair of the proximal aortic arch is associated with good mid-term outcomes in patients considered too high-risk for open repair. However, reimbursement does not adequately cover treatment cost, with net technical margins being negative in nearly all cases. To remain financially sustainable, efforts should be made to both optimize aortic arch TEVAR delivery as well as advocate for reimbursement commensurate with associated costs.

Medicare costs for endovascular abdominal aortic aneurysm treatment in the Vascular Quality Initiative.

BACKGROUND: Reintervention after endovascular repair (EVR) of abdominal aortic aneurysms is common. However, the cumulative financial impact of reintervention after EVR on a national scale is poorly defined. Our objective was to describe the cost to Medicare for aneurysm treatment (EVR plus reinterventions) among a cohort of patients with known follow-up for 5 years after repair. METHODS: We identified patients who underwent EVR within the Vascular Quality Initiative who were linked to their respective Medicare claims file (n = 13,995). We excluded patients who underwent EVR after September 30, 2010, and those who had incomplete Medicare coverage (n = 12,788). The remaining cohort (n = 1207) had complete follow-up until death or 5 years (Medicare data available through September 30, 2015). We then obtained and compiled the corresponding Medicare reimbursement data for the index EVR hospitalization and all subsequent reinterventions. RESULTS: We studied 1207 Medicare patients who underwent EVR and had known follow-up for reinterventions for 5 years. The mean age was 76.2 years (±7.1 years), 21.6% of patients were female, and 91.1% of procedures were elective. The Kaplan-Meier reintervention rate at 5 years was 18%. Among patients who underwent reintervention, 154 (73.7%) had a single reintervention, 40 (19.1%) had two reinterventions, and 15 (7.2%) had three or more reinterventions. The median cost to Medicare for the index EVR hospitalization was $25,745 (interquartile range, $21,131-$28,774). The median cost for subsequent reinterventions was $22,165 (interquartile range, $17,152-$29,605). The cumulative cost to Medicare of aneurysm treatment (EVR plus reinterventions) increased in a stepwise fashion among patients who underwent multiple reinterventions, with each reintervention being similar in cost to the index EVR. CONCLUSIONS: The overall cost incurred by Medicare to reimburse for each reintervention after EVR is roughly the same as for the initial procedure itself, meaning that Medicare cost projections would be greater than $100,000 for any individual who undergoes an EVR with three reinterventions. The long-term financial impact of EVR must be considered by surgeons, patients, and healthcare systems alike as these cumulative costs may hinder the fiscal viability of an EVR-first therapeutic approach and highlight the need for judicious patient selection paradigms.

The financial evolution of endovascular aneurysm repair delivery in contemporary practice.

OBJECTIVE: The fiscal impact of endovascular repair (EVR) of aortic aneurysms and the requisite device costs have previously highlighted the tenuous long-term financial sustainability among Medicare beneficiaries. The Centers for Medicare & Medicaid Services have since reclassified EVR remuneration paradigms with new Medicare Severity Diagnosis-Related Groups (MS-DRGs) intended to better address the procedure's cost profile. The impact of this change remains unknown. The purpose of this analysis was to compare EVR-specific costs and revenue among Medicare beneficiaries both before and after this change. METHODS: All infrarenal EVRs performed in fiscal years (FYs) 2014 and 2015, before the MS-DRG change, and those performed in FYs 2017 and 2018, after the MS-DRG change, were identified using the DRG codes 238 (n = 108) and 269 (n = 84), respectively. We then identified those who were treated according to the instructions for use guidelines with a single manufacturer's device and billed to Medicare (n = 23 in FY14-15; n = 22 in FY17-18). From these cohorts, we determined total procedure technical costs, technical revenue, and net technical margin in conjunction with the hospital finance department. Results were then compared between these two groups. RESULTS: The two cohorts demonstrated similar demographic profiles (FY14-15 vs FY17-18 cohort: age, 78 years vs 74 years; median length of stay, 1.0 day vs 1.0 day). Mean total technical costs were slightly higher in the FY17-18 group ($24,511 in FY14-15 vs $26,445 in FY17-18). Graft implants continued to account for a significant portion of the total cost, with the device cost accounting for 56% of the total procedure costs in both cohorts. Net revenue was greater in the FY17-18 group by $5800 ($30,698 in FY14-15 vs $36,498 in FY17-18), resulting in an increased overall margin in the FY17-18 group compared with the FY14-15 group ($6188 in FY14-15 vs $10,053 in FY17-18). CONCLUSIONS: Device costs remain the single greatest cost driver associated with EVR delivery. DRG reclassification of EVR to address total procedure and implant costs appears to better address the requisite associated procedure costs and may thereby better support long-term fiscal sustainability of this procedure for hospitals and health systems alike.

Longitudinal Spending on Endovascular and Open Abdominal Aortic Aneurysm Repair.

BACKGROUND: Endovascular repair (EVR) has replaced open surgery as the procedure of choice for patients requiring elective abdominal aortic aneurysm (AAA) repair. Long-term outcomes of the 2 approaches are similar, making the relative cost of caring for these patients over time an important consideration. METHODS AND RESULTS: We linked Medicare claims to Vascular Quality Initiative registry data for patients undergoing elective EVR or open AAA repair from 2004 to 2015. The primary outcome was Medicare's cumulative disease-related spending, adjusted to 2015 dollars. Disease-related spending included the index operation and associated hospitalization, surveillance imaging, reinterventions (AAA-related and abdominal wall procedures), and all-cause admissions within 90 days. We compared the incidence of disease-related events and cumulative spending at 90 days and annually through 7 years of follow-up. The analytic cohort comprised 6804 EVR patients (median follow-up: 1.85 years; interquartile range: 0.82-3.22 years) and 1889 open repair patients (median follow-up: 2.62 years; interquartile range: 1.13-4.80 years). Spending on index surgery was significantly lower for EVR (median [interquartile range]: $25 924 [$22 280-$32 556] EVR versus $31 442 [$24 669-$40 419] open; P<0.001), driven by a lower rate of in-hospital complications (6.6% EVR versus 38.0% open; P<0.001). EVR patients underwent more surveillance imaging (1.8 studies per person-year EVR versus 0.7 studies per person-year open; P<0.001) and AAA-related reinterventions (4.0 per 100 person-years EVR versus 2.1 per 100 person-years open; P=0.041). Open repair patients had higher rates of 90-day readmission (12.9% EVR versus 17.8% open; P<0.001) and abdominal wall procedures (0.6 per 100 person-years EVR versus 1.5 per 100 person-years open; P<0.001). Overall, EVR patients incurred more disease-related spending in follow-up ($7355 EVR versus $2706 open through 5 years). There was no cumulative difference in disease-related spending between surgical groups by 5 years of follow-up (-$33 EVR [95% CI: -$1543 to $1476]). CONCLUSIONS: We observed no cumulative difference in disease-related spending on EVR and open repair patients 5 years after surgery. Generalized recommendations about which approach to offer elective AAA patients should not be based on relative cost.

Five-year reintervention after endovascular abdominal aortic aneurysm repair in the Vascular Quality Initiative.

OBJECTIVE: Patients who undergo endovascular abdominal aortic aneurysm repair (EVR) remain at risk for reintervention and rupture. We sought to define the 5-year rate of reintervention and rupture after EVR in the Vascular Quality Initiative (VQI). METHODS: We identified all patients in the VQI who underwent EVR from 2003 to 2015. We linked patients in the VQI to Medicare claims for long-term outcomes. We stratified patients on baseline clinical and procedural characteristics to identify those at risk for reintervention. Our primary outcomes were 5-year rates of reintervention and late aneurysm rupture after EVR. We assessed these with Kaplan-Meier survival estimation. RESULTS: We studied 12,911 patients who underwent EVR. The mean age was 75.5 years, 79.9% were male, 3.9% were black, and 89.1% of operations were performed electively. The 5-year rate of reintervention for the entire cohort was 21%, and the 5-year rate of late aneurysm rupture was 3%. Reintervention rates varied across categories of EVR urgency. Patients who underwent EVR electively had the lowest 5-year rate of reintervention at 20%. Those who underwent surgery for symptomatic aneurysms had higher rates of reintervention at 25%. Patients undergoing EVR emergently for rupture had the highest rate of reintervention, 27% at 4 years (log-rank across the three groups, P < .001). Black race and aneurysm size of 6.0 cm or greater were associated with significantly elevated reintervention rates (black, 31% vs white, 20% [log-rank, P < .001]; aneurysm size 6.0 cm or greater, 27% vs all others, <20% [log-rank, P < .001]). There were no significant associations between age or gender and the 5-year rate of reintervention. CONCLUSIONS: More than one in five Medicare patients undergo reintervention within 5 years after EVR in the VQI; late rupture remains low at 3%. Black patients, those with large aneurysms, and those who undergo EVR urgently and emergently have a higher likelihood of adverse outcomes and should be the focus of diligent long-term surveillance.

Characterizing Reimbursements for Medicare Patients Receiving Endovascular Abdominal Aortic Aneurysm Repair at Vascular Quality Initiative Centers.

BACKGROUND: Endovascular aortic aneurysm repair (EVR) has a major financial impact on health care systems. We characterized reimbursement for index EVR hospitalizations among Medicare beneficiaries having surgery at Vascular Quality Initiative (VQI) centers. METHODS: We linked Medicare claims to VQI clinical registry data for patients undergoing EVR from 2003 to 2015. Analysis was limited to patients fully covered by fee-for-service Medicare parts A and B in the year of their operation and assigned a corresponding diagnosis-related group for EVR. The primary outcome was Medicare's reimbursement for inpatient hospital and professional services, adjusted to 2015 dollars. We performed descriptive analysis of reimbursement over time and univariate analysis to evaluate patient demographics, clinical characteristics, procedural variables, and postoperative events associated with reimbursement. This informed a multilevel regression model used to identify factors independently associated with EVR reimbursement and quantify VQI center-level variation in reimbursement. RESULTS: We studied 9,403 Medicare patients who underwent EVR at VQI centers during the study period. Reimbursements declined from $37,450 ± $9,350 (mean ± standard deviation) in 2003 to $27,723 ± $10,613 in 2015 (test for trend, P < 0.001). For patients experiencing a complication (n = 773; 8.2%), mean reimbursement for EVR was $44,858 ± $23,825 versus $28,857 ± $9,258 for those without complications (P < 0.001). Intestinal ischemia, new dialysis requirement, and respiratory compromise each doubled Medicare's average reimbursement for EVR. After adjusting for diagnosis-related group, several patient-level factors were independently associated with higher Medicare reimbursement; these included ruptured abdominal aortic aneurysm (+$2,372), additional day in length of stay (+$1,275), and being unfit for open repair (+$501). Controlling for patient-level factors, 4-fold variation in average reimbursement was seen across VQI centers. CONCLUSIONS: Reimbursement for EVR declined between 2003 and 2015. We identified preoperative clinical factors independently associated with reimbursement and quantified the impact of different postoperative complications on reimbursement. More work is needed to better understand the substantial variation observed in reimbursement at the center level.

Using the Idea, Development, Exploration, Assessment, Long-Term Study Framework for Devices (IDEAL-D) to Better Understand the Evolution of Evidence Surrounding Fenestrated Abdominal Aortic Endovascular Grafts.

The use of fenestrated endovascular devices for repair of complex aortic aneurysms has increased to nearly 5,000 implantations annually among Medicare patients in the United States in recent years. Given that nearly all aspects of treatment for minimally invasive aortic intervention rely on medical devices to better care for patients with vascular disease, clearly understanding how new and innovative technology evolves over the life cycle of a medical device is an essential skill set for cardiovascular physicians. Despite the need for this understanding, there is no standard framework upon which cardiovascular physicians, regulators, and patients can rely on to better understand the evolution of evidence from product inception through adoption and long-term effectiveness evaluation. As the aforementioned devices are increasingly and broadly used, the need for a formal framework for regulation and device approval has emerged. The goal of this review is to describe the Idea, Development, Exploration, Assessment, Long-term Study Framework for Devices (IDEAL-D). This framework is a model developed recently by an international panel of experts dedicated to better understanding the data steps necessary to bring a device from idea to routine practice and further to marketing, approval, and monitoring. In this review, we use the example of fenestrated endovascular aortic devices to illustrate the IDEAL-D framework, how it can help cardiovascular physicians improve their understanding of new technology, and the evidence which surrounds it from inception to long-term use.

Claims-based surveillance for reintervention after endovascular aneurysm repair among non-Medicare patients.

OBJECTIVE: Many patients who undergo endovascular aortic aneurysm repair (EVR) also undergo repeat procedures, or reinterventions, to address suboptimal device performance and prevent aneurysm rupture. Quality improvement initiatives measuring reintervention after EVR has focused on fee-for-service Medicare patients. However, because patients aged less than 65 years and those with Medicare Advantage represent an important growing subgroup, we used a novel approach leveraging a state data source that captures patients of all ages and with all types of insurance. METHODS: We identified patients who underwent EVR (2011-2015) within the Vascular Quality Initiative registry and were also listed in the Statewide Planning and Research Cooperative System all-payer claims database of New York. We linked patients in the Vascular Quality Initiative to their Statewide Planning and Research Cooperative System claims file at the patient level with a 96% match rate. We compared outcomes between fee-for-service Medicare eligible, defined as age 65 or older or on dialysis, versus ineligible patients, defined as those younger than 65 and not on dialysis. Our primary outcome was reintervention. We used Cox proportional hazards regression and propensity score matching for risk adjustment. RESULTS: We studied 1285 patients with a median follow-up of 16 months (range, 1-57 months). The mean age was 74 years, 79% were male, and 84% of procedures were elective. Nearly one in six patients were not Medicare eligible (14%), and the remainder (86%) were Medicare eligible. Medicare-eligible patients were less likely to be male (77% vs 91%; P < .001), have a history of smoking (79% vs 93%; P < .001), and have a nonelective procedure (15% vs 23%; P = .013). The 3-year Kaplan-Meier rate of reintervention was 21%. We found similar rates of reintervention between Medicare-eligible patients and those who were not (19% vs 20%, log-rank P = .199; unadjusted hazard ratio [HR], 0.75; 95% confidence interval [CI], 0.49-1.16). This finding persisted in both the adjusted and propensity-matched analyses (adjusted HR, 0.82; 95% CI, 0.50-1.34; propensity-matched HR, 0.70; 95% CI, 0.36-1.37). CONCLUSIONS: Reintervention can be monitored using administrative claims from both Medicare and non-Medicare payers, and serve as an important outcome metric after EVR in patients of all ages. The rate of reintervention seems to be similar between older, Medicare-eligible individuals, and those who are not yet eligible.

A comparative analysis of long-term mortality after carotid endarterectomy and carotid stenting.

BACKGROUND: The value of carotid intervention is predicated on long-term survival for patients to derive a stroke prevention benefit. Randomized trials report no significant difference in survival after carotid endarterectomy (CEA) vs carotid artery stenting (CAS), whereas observational studies of "real-world" outcomes note that CEA is associated with a survival advantage. Our objective was to examine long-term mortality after CEA vs CAS using a propensity-matched cohort. METHODS: We studied all patients who underwent CEA or CAS within the Vascular Quality Initiative from 2003 to 2013 (CEA, n = 29,235; CAS, n = 4415). Long-term mortality information was obtained by linking patients in the registry to their respective Medicare claims file. We assessed the long-term rate of mortality for CEA and CAS using Kaplan-Meier estimation. We assessed the crude, adjusted, and propensity-matched (total matched pairs, n = 4261) hazard ratio (HR) of mortality for CEA vs CAS using Cox regression. RESULTS: The unadjusted Kaplan-Meier estimated 5-year mortality was 14.0% for CEA and 18.3% for CAS. The crude HR of all-cause mortality for CEA vs CAS was 0.75 (95% confidence interval [CI], 0.70-0.81), indicating that patients who underwent CEA were 25% less likely to die before those who underwent CAS. This survival advantage persisted after adjustment for age, sex, and comorbidities (adjusted HR, 0.75; 95% CI, 0.69-0.82). This effect was confirmed on a propensity-matched analysis, with an HR of 0.76 (95% CI, 0.69-0.85). Finally, these findings were robust to subanalyses that stratified patients by presenting symptoms and were more pronounced in symptomatic patients (adjusted HR, 0.69; 95% CI, 0.61-0.79) than in asymptomatic patients (adjusted HR, 0.80; 95% CI, 0.71-0.90). CONCLUSIONS: During the last 15 years, patients who underwent CEA in the Vascular Quality Initiative have a long-term survival advantage over those who underwent CAS in real-world practice. Despite no difference in long-term survival in randomized trials, our observational study demonstrated a survival benefit for CEA that did not diminish with risk adjustment.

A comparison of reintervention rates after endovascular aneurysm repair between the Vascular Quality Initiative registry, Medicare claims, and chart review.

OBJECTIVE: The accurate measurement of reintervention after endovascular aneurysm repair (EVAR) is critical during postoperative surveillance. The purpose of this study was to compare reintervention rates after EVAR from three different data sources: the Vascular Quality Initiative (VQI) alone, VQI linked to Medicare claims (VQI-Medicare), and a "gold standard" of clinical chart review supplemented with telephone interviews. METHODS: We reviewed the medical records of 729 patients who underwent EVAR at our institution between 2003 and 2013. We excluded patients without follow-up reported to the VQI (n = 68 [9%]) or without Medicare claims information (n = 114 [16%]). All patients in the final analytic cohort (n = 547) had follow-up information available from all three data sources (VQI alone, VQI linked to Medicare, and chart review). We then compared reintervention rates between the three data sources. Our primary end points were the agreement between the three data sources and the Kaplan-Meier estimated rate of reintervention at 1 year, 2 years, and 3 years after EVAR. For gold standard assessment, we supplemented chart review with telephone interview as necessary to assess reintervention. RESULTS: VQI data alone identified 12 reintervention events in the first year after EVAR. Chart review confirmed all 12 events and identified 18 additional events not captured by the VQI. VQI-Medicare data successfully identified all 30 of these events within the first year. VQI-Medicare also documented four reinterventions in this time period that did not occur on the basis of patient interview (4/547 [0.7%]). The agreement between chart review and VQI-Medicare data at 1 year was excellent (κ = 0.93). At 3 years, there were 81 (18%) reinterventions detected by VQI-Medicare and 70 (16%) detected by chart review for a sensitivity of 92%, specificity of 96%, and κ of 0.80. Kaplan-Meier survival analysis demonstrated similar reintervention rates after 3 years between VQI-Medicare and chart review (log-rank, P = .59). CONCLUSIONS: Chart review after EVAR demonstrated a 6% 1-year and 16% 3-year reintervention rate, and almost all (92%) of these events were accurately captured using VQI-Medicare data. Linking VQI data with Medicare claims allows an accurate assessment of reintervention rates after EVAR without labor-intensive physician chart review.

Patient Experience of Recovery After Major Leg Amputation for Arterial Disease.

OBJECTIVES: To date, studies of vascular amputees primarily examine quantitative outcomes following limb loss. Less is known about the patient's perspective after major lower limb amputation. Here, we define and describe the postamputation recovery period. METHODS: Qualitative study using purposive, maximum variation sampling on the variables of amputation level and times since surgery. We first conducted structured interviews with 20 participants (median age: 65 years, range: 45-88 years; 85% male; below knee amputation n = 14; above knee amputation n = 6; median time from amputation to interview = 16 months, range: 4-51 months). Findings were validated via a focus group with 5 amputees. Data were coded, analyzed, and interpreted by 2 reviewers. RESULTS: All participants expressed the desire to have an active role in the decision to undergo amputation, even while acknowledging that limb salvage options were exhausted. Following amputation, participants described a 6-month recovery period when they learned to modify daily activities to accommodate their new functional and psychological needs. Participants defined recovery as when they had regained functional independence, which was described as a level of mobility that allowed them to perform daily activities with minimal assistance. Concerns that participants felt were poorly addressed included uncontrolled pain, feeling unprepared to live with an amputation, and questions about prosthetics. Two of the 5 focus group participants stated a preference for amputation earlier in the treatment course. CONCLUSIONS: Postamputation recovery has an early (up to 6 months) and late phase (after 6 months) and concludes when amputees regain what they perceive as independence. Patients desire to participate in amputation decision-making; in this study, some would have preferred amputation earlier in their clinical course. Attention to the domains that impact quality of life, and fostering a shared decision-making process, are opportunities to enhance postamputation recovery.

National trends in open surgical, endovascular, and branched-fenestrated endovascular aortic aneurysm repair in Medicare patients.

BACKGROUND: Open repair effectively prevents rupture for patients with abdominal aortic aneurysm (AAA) and is commonly studied as a metric reflecting hospital and surgeon expertise in cardiovascular care. However, given recent advances in endovascular aneurysm repair (EVAR), such as branched-fenestrated EVAR, it is unknown how commonly open surgical repair is still used in everyday practice. METHODS: We analyzed trends in open AAA repair, EVAR, and branched-fenestrated EVAR for AAA in Medicare beneficiaries from 2003 to 2013. We used Medicare Part B claims to ascertain counts of these repair types annually during the study period. We assessed regional and national trends in characteristics of the patients and procedure volume. RESULTS: Between 2003 and 2013, the total number of AAA repairs performed in fee-for-service Medicare patients declined by 26% from 31,582 to 23,421 (P < .001), after a peak number of 32,540 was performed in 2005 (28% decline since 2005). The number of open AAA repairs steadily declined by a total of 76%, from 20,533 in 2003 to 4916 in 2013 (P < .001). Whereas the number of EVARs increased from 11,049 in 2003 to 19,247 in 2011 (P < .001), it has since declined a total of 15% to only 16,362 repairs in 2013 (P < .001). After its introduction in 2011, the number of branched-fenestrated EVAR cases continuously rose from 335 procedures in 2011 to 2143 procedures in 2013 (P < .001). By 2013, virtually all hospital referral regions in the United States had rates of open AAA repair that would have been in the lowest quintile of volume in 2003. CONCLUSIONS: The number of open AAA repairs fell by nearly 80% during the last decade, whereas traditional EVAR declined slightly and branched-fenestrated EVAR rapidly disseminated into national practice. These results suggest that open AAA repair is now performed too infrequently to be used as a metric in the assessment of hospital and surgeon quality in cardiovascular care. Furthermore, surgical training paradigms will need to reflect the changing dynamics necessary to ensure that surgeons and interventionists can safely perform these high-risk surgical procedures.