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 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.

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.

Assessment of listing and categorisation of animal diseases within the framework of the Animal Health Law (Regulation (EU) 2016/429): infection with Gyrodactylus salaris (GS).

Infection with Gyrodactylus salaris was assessed according to the criteria of the Animal Health Law (AHL), in particular, the criteria of Article 7 on disease profile and impacts, Article 5 on its eligibility to be listed, Annex IV for its categorisation according to disease prevention and control rules as laid down in Article 9 and Article 8 for listing animal species related to infection with G. salaris. The assessment was performed following the ad hoc method for data collection and assessment previously developed by AHAW panel and already published. The outcome reported is the median of the probability ranges provided by the experts, which indicates whether each criterion is fulfilled (lower bound ≥ 66%) or not (upper bound ≤ 33%), or whether there is uncertainty about fulfilment. Reasoning points are reported for criteria with an uncertain outcome. According to the assessment here performed, it is uncertain whether infection with G. salaris can be considered eligible to be listed for Union intervention according to Article 5 of the AHL (33-70% probability). According to the criteria in Annex IV, for the purpose of categorisation related to the level of prevention and control as in Article 9 of the AHL, the AHAW Panel concluded that Infection with G. salaris does not meet the criteria in Section 1 and 3 (Category A and C; 1-5% and 10-33% probability of fulfilling the criteria, respectively) and it is uncertain whether it meets the criteria in Sections 2, 4 and 5 (Categories B, D and E; 33-80%, 33-66% and 33-80% probability of meeting the criteria, respectively). The animal species to be listed for infection with G. salaris according to Article 8 criteria are provided.

Assessment of listing and categorisation of animal diseases within the framework of the Animal Health Law (Regulation (EU) 2016/429): Bacterial kidney disease (BKD).

Bacterial kidney disease (BKD) was assessed according to the criteria of the Animal Health Law (AHL), in particular the criteria of Article 7 on disease profile and impacts, Article 5 on its eligibility to be listed, Annex IV for its categorisation according to disease prevention and control rules as laid out in Article 9 and Article 8 for listing animal species related to BKD. The assessment was performed following the ad hoc method on data collection and assessment developed by AHAW Panel and already published. The outcome reported is the median of the probability ranges provided by the experts, which indicates whether each criterion is fulfilled (lower bound ≥ 66%) or not (upper bound ≤ 33%), or whether there is uncertainty about fulfilment. Reasoning points are reported for criteria with an uncertain outcome. According to this assessment, BKD can be considered eligible to be listed for Union intervention according to Article 5 of the AHL (66-90% probability). According to the criteria in Annex IV, for the purpose of categorisation related to the level of prevention and control as in Article 9 of the AHL, the AHAW Panel concluded that BKD does not meet the criteria in Sections 1, 2 and 3 (Categories A, B and C; 1-5%, 33-66% and 33-66% probability of meeting the criteria, respectively) but meets the criteria in Sections 4 and 5 (Categories D and E; 66-90% and 66-90% probability of meeting the criteria, respectively). The animal species to be listed for BKD according to Article 8 criteria are provided.

Assessment of listing and categorisation of animal diseases within the framework of the Animal Health Law (Regulation (EU)2016/429): Infection with salmonid alphavirus (SAV).

Infection with salmonid alphavirus (SAV) was assessed according to the criteria of the Animal Health Law (AHL), in particular the criteria of Article 7 on disease profile and impacts, Article 5 on its eligibility to be listed, Annex IV for its categorisation according to disease prevention and control rules as laid out in Article 9 and Article 8 for listing animal species related to infection with SAV. The assessment was performed following the ad hoc method on data collection and assessment developed by AHAW Panel and already published. The outcome reported is the median of the probability ranges provided by the experts, which indicates whether each criterion is fulfilled (lower bound ≥ 66%) or not (upper bound ≤ 33%), or whether there is uncertainty about fulfilment. Reasoning points are reported for criteria with an uncertain outcome. According to the assessment, it was uncertain whether infection with salmonid alphavirus can be considered eligible to be listed for Union intervention according to Article 5 of the AHL (50-80% probability). According to the criteria in Annex IV, for the purpose of categorisation related to the level of prevention and control as in Article 9 of the AHL, the AHAW Panel concluded that infection with salmonid alphavirus does not meet the criteria in Section 1 (Category A; 5-10% probability of meeting the criteria) and it is uncertain whether it meets the criteria in Sections 2, 3, 4 and 5 (Categories B, C, D and E; 50-90%, probability of meeting the criteria). The animal species to be listed for infection with SAV according to Article 8 criteria are provided.

Assessment of listing and categorisation of animal diseases within the framework of the Animal Health Law (Regulation (EU) 2016/429): Spring Viraemia of Carp (SVC).

Spring Viraemia of Carp (SVC) was assessed according to the criteria of the Animal Health Law (AHL), in particular the criteria of Article 7 on disease profile and impacts, Article 5 on its eligibility to be listed, Annex IV for its categorisation according to disease prevention and control rules as in Article 9 and Article 8 for listing animal species related to SVC. The assessment was performed following the ad hoc method for data collection and assessment previously developed by the AHAW panel and already published. The outcome reported is the median of the probability ranges provided by the experts, which indicates whether each criterion is fulfilled (lower bound ≥ 66%) or not (upper bound ≤ 33%), or whether there is uncertainty about fulfilment. Reasoning points are reported for criteria with an uncertain outcome. According to the assessment performed here, it is uncertain whether SVC can be considered eligible to be listed for Union intervention according to Article 5 of the AHL (45-90% probability). According to the criteria in Annex IV, for the purpose of categorisation related to the level of prevention and control as in Article 9 of the AHL, the AHAW Panel concluded that SVC does not meet the criteria in Section 1 (Category A; 5-33% probability of meeting the criteria) and it is uncertain whether it meets the criteria in Sections 2, 3, 4 and 5 (Categories B, C, D and E; 33-66%, 10-66%, 45-90% and 45-90% probability of meeting the criteria, respectively). The animal species to be listed for SVC according to Article 8 criteria are provided.

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.

Assessment of listing and categorisation of animal diseases within the framework of the Animal Health Law (Regulation (EU) No 2016/429): infectious pancreatic necrosis (IPN).

Infectious pancreatic necrosis (IPN) was assessed according to the criteria of the Animal Health Law (AHL), in particular, the criteria of Article 7 on disease profile and impacts, Article 5 on its eligibility to be listed, Annex IV for its categorisation according to disease prevention and control rules as in Article 9, and Article 8 for listing animal species related to IPN. The assessment was performed following a methodology previously published. The outcome reported is the median of the probability ranges provided by the experts, which indicates whether each criterion is fulfilled (lower bound ≥ 66%) or not (upper bound ≤ 33%), or whether there is uncertainty about fulfilment. Reasoning points are reported for criteria with an uncertain outcome. According to the assessment here performed, it is uncertain whether IPN can be considered eligible to be listed for Union intervention according to Article 5 of the AHL (50-90% probability). According to the criteria in Annex IV, for the purpose of categorisation related to the level of prevention and control as in Article 9 of the AHL, the AHAW Panel concluded that IPN does not meet the criteria in Section 1 (Category A; 0-1% probability of meeting the criteria) and it is uncertain whether it meets the criteria in Sections 2, 3, 4 and 5 (Categories B, C, D and E; 33-66%, 33-66%, 50-90% and 50-99% probability of meeting the criteria, respectively). The animal species to be listed for IPN according to Article 8 criteria are provided.

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.

Contemporary incidence, outcomes, and survival associated with endovascular aortic aneurysm repair conversion to open repair among Medicare beneficiaries.

OBJECTIVE: The widespread application of endovascular abdominal aortic aneurysm repair (EVAR) has ushered in an era of requisite postoperative surveillance and the potential need for reintervention. The national prevalence and results of EVAR conversion to open repair, however, remain poorly defined. The purpose of this analysis was to define the incidence of open conversion and its associated outcomes. METHODS: The SVS Vascular Quality Initiative EVAR registry linked to Medicare claims via Vascular Implants Surveillance and Interventional Outcomes Network was queried for open conversions after initial EVAR procedures from 2003 to 2016. Cumulative conversion incidence within up to 5 years after EVAR and outcomes after open intervention were determined. Multivariable logistic regressions were used to identify independent predictors of conversion and mortality. RESULTS: Among 15,937 EVAR patients, 309 (1.9%) underwent an open conversion: 43% (n = 132) early (<30 days) and 57% (n = 177) late (>30 days). The longitudinally observed rate of conversion was constant over time, as well as by geographic region. Independent predictors of conversion included female sex (hazard ratio [HR], 1.49; P < .001), aneurysm diameter or more than 6.0 cm at the time of index EVAR (HR, 1.74; P < .001), nonelective repair (compared with elective presentation: HR, 1.72; P < .001), and aortouni-iliac repairs (HR, 2.19; P < .001). In contrast, adjunctive operative procedures such as endo-anchors or cuff extensions (HR, 0.62; P = .06) were protective against long-term conversion. Both early (HR, 1.6; P < .001) and late (HR, 1.26; P = .07) open conversions were associated with significant 30-day (total cohort, 15%) and 1-year mortality (total cohort, 25%). Patients undergoing open conversion experienced high rates of 30-day readmission (42%) and cardiac (45%), renal (32%), and pulmonary (30%) complications. CONCLUSIONS: This large, registry-based analysis is among the first to document the incidence and outcomes for open conversion after EVAR in a national cohort with long-term follow-up. Importantly, women, patients with large aneurysms, and complex anatomy, as well as urgent or emergent EVARs are at an increased risk for open conversion. It seems that more conversions are performed in the early postoperative period, despite perceptions that conversion is a delayed phenomenon. In all instances, conversion is associated with significant morbidity and mortality and highlights the importance of appropriate patient selection at the time of index EVAR.

Performance of intensive care unit severity scoring systems across different ethnicities in the USA: a retrospective observational study.

BACKGROUND: Despite wide use of severity scoring systems for case-mix determination and benchmarking in the intensive care unit (ICU), the possibility of scoring bias across ethnicities has not been examined. Guidelines on the use of illness severity scores to inform triage decisions for allocation of scarce resources, such as mechanical ventilation, during the current COVID-19 pandemic warrant examination for possible bias in these models. We investigated the performance of the severity scoring systems Acute Physiology and Chronic Health Evaluation IVa (APACHE IVa), Oxford Acute Severity of Illness Score (OASIS), and Sequential Organ Failure Assessment (SOFA) across four ethnicities in two large ICU databases to identify possible ethnicity-based bias. METHODS: Data from the electronic ICU Collaborative Research Database (eICU-CRD) and the Medical Information Mart for Intensive Care III (MIMIC-III) database, built from patient episodes in the USA from 2014-15 and 2001-12, respectively, were analysed for score performance in Asian, Black, Hispanic, and White people after appropriate exclusions. Hospital mortality was the outcome of interest. Discrimination and calibration were determined for all three scoring systems in all four groups, using area under receiver operating characteristic (AUROC) curve for different ethnicities to assess discrimination, and standardised mortality ratio (SMR) or proxy measures to assess calibration. FINDINGS: We analysed 166 751 participants (122 919 eICU-CRD and 43 832 MIMIC-III). Although measurements of discrimination were significantly different among the groups (AUROC ranging from 0·86 to 0·89 [p=0·016] with APACHE IVa and from 0·75 to 0·77 [p=0·85] with OASIS), they did not display any discernible systematic patterns of bias. However, measurements of calibration indicated persistent, and in some cases statistically significant, patterns of difference between Hispanic people (SMR 0·73 with APACHE IVa and 0·64 with OASIS) and Black people (0·67 and 0·68) versus Asian people (0·77 and 0·95) and White people (0·76 and 0·81). Although calibrations were imperfect for all groups, the scores consistently showed a pattern of overpredicting mortality for Black people and Hispanic people. Similar results were seen using SOFA scores across the two databases. INTERPRETATION: The systematic differences in calibration across ethnicities suggest that illness severity scores reflect statistical bias in their predictions of mortality. FUNDING: There was no specific funding for this study.

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.

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.

Health assessment of the cleaner fish ballan wrasse Labrus bergylta from the British south-west coast.

Wild-caught ballan wrasse Labrus bergylta are translocated en masse from the British south-west coast to Scotland for use as cleaner fish to tackle Atlantic salmon Salmo salar sea lice infestations; however, very little is known about the background health status of this species. This is the first health assessment of wild ballan wrasse from the British south-west. Wild-caught ballan wrasse (n = 75) from coastal populations off Dorset and Cornwall were subjected to a full health screen for viral, bacterial and parasitic infections and associated pathology. A range of metazoan and protozoan parasites were observed in histological sections, including copepods (sea lice Caligus centrodonti), nematodes, cestodes, digenean metacercariae, Cryptocaryon-like ciliates and an intestinal coccidian (Eimeria sp.) observed in 26.6% of the samples. The mycoplasma Acholeplasma laidlawii was associated with cytopathic effect in cell culture inoculated with tissue homogenates. The opportunistic pathogen Photobacterium damselae damselae was isolated from a single fish with a systemic infection. The isolate was confirmed to possess the virulence factors hlyAch and plpV, previously associated with cell toxicity and pathogenicity to fish. There are no immediate concerns for the continued mass translation of ballan wrasse, however careful monitoring of the population is recommended.

Risk and outcome profile of carotid endarterectomy with proximal intervention is concerning in multi-institutional assessment.

OBJECTIVE: Approaching tandem bifurcation and brachiocephalic disease using carotid endarterectomy (CEA) with ipsilateral proximal endovascular intervention (IPE) has been promulgated as safe and durable. There have been recent concerns about neurologic risk with this technique. The goal of this study was to define stroke and perioperative risk with this uncommon procedure across multiple centers. METHODS: Between August 2002 and July 2016, patients who underwent CEA + IPE were identified by operative records at three institutions. Primary end points were perioperative stroke and death, restenosis, freedom from neurologic event, and need for reintervention. Factors related to these end points were analyzed. RESULTS: There were 62 patients who underwent CEA + IPE. The average age was 69 ± 9 years. Most were female 34 (55%); 56 (90%) were taking a statin and at least one antiplatelet agent. Bilateral internal carotid stenosis (>50%) was present in 32 (52%); 26 (42%) patients were symptomatic and 12 (19%) had undergone prior ipsilateral CEA. Bifurcation operations included longitudinal CEA/patch (38 [61%]), eversion CEA (20 [32%]), bypass graft (3 [5%]), and CEA/primary repair (1 [2%]). CEA was performed first in 53 (85%). All IPEs included stenting, with a single stent used in 58 (94%). Balloon-expandable stents were placed in the majority of patients (51 [82%]). Proximal arteries treated included the innominate (20 [32%]), left common carotid (32 [52%]), right common carotid (8 [13%]) and both innominate and right common carotid (2 [3%]). IPE was protected by carotid cross-clamp in 48 (77%). Shunting occurred in 14 (23%). There were four (6.5%) perioperative ipsilateral strokes and two hyperperfusion events. There were three (4.8%) operative deaths, one from stroke and two cardiovascular. Combined stroke and death rate was 11.3% and was not different between centers. Mean clinical follow-up was 6 ± 4 years. Mean imaging follow-up was 3 ± 4 years. Restenosis ≥50% at either intervention occurred in 20 (34%). Reintervention was performed for five proximal and three bifurcation failures (14%). Symptomatic status, redo operation, carotid clamp protection, multiple stents, and procedural order were not associated with operative stroke. Carotid clamp protection was associated with less restenosis (P = .003). Redo operation (P = .04) and hyperlipidemia (P = .05) were associated with reintervention. The 5-year actuarial survival was 81%, whereas freedom from stroke and reintervention were 94% and 81%, respectively. CONCLUSIONS: Perioperative stroke and death with CEA + IPE are substantial and consistent across centers. It is strikingly different from isolated CEA or CEA added to open brachiocephalic reconstruction. Restenosis is frequent, and reintervention at either the proximal stent or bifurcation is common. This technical strategy should be used cautiously and selectively reserved for those who are symptomatic with hemodynamically relevant tandem lesions and unfit for open revascularization.