Early outcomes from the pivotal trial of a four-branch off-the shelf solution to treat complex abdominal and type IV thoracoabdominal aortic aneurysms.

BACKGROUND: This study reports the 30-day outcomes of the primary arm of the GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (TAMBE) pivotal trial for complex abdominal aortic aneurysm repair. METHODS: This multicenter, nonrandomized, prospective study of the TAMBE device included patients enrolled in the primary study arm of extent IV thoracoabdominal aortic aneurysms and pararenal aneurysms. Technical success and major adverse events were analyzed per the Society for Vascular Surgery guidelines. RESULTS: The 102 patients of the primary arm who underwent endovascular repair using the TAMBE device were a mean age of 73 ± 6.4 years (range, 58-82 years) and 84 (84.2%) were male. The mean body mass index was 28.3 ± 5.0 kg/m2. Fifty-nine patients (57.8%) were treated for extent IV and 43 (42.2%) pararenal aneurysms; the mean maximum diameter of the aneurysms was 59.4 ± 7.8 mm. A prophylactic cerebral spinal fluid drain was used in 10 patients (9.8%). Technical success was achieved in 99% of patients, with the single failure owing to unsuccessful cannulation of the left renal artery. Mean procedure time was 315 ± 103 minutes (range, 163-944 minutes), estimated blood loss was 300 ± 296 mL (range, 10-2000 mL), and contrast administration was 153.6 ± 73.5 mL (range, 16-420 mL). The intensive care unit length of stay was 58.7 ± 52.7 hours (range, 1-288 mL). In 28 patients (27.5%), a total of 32 additional endovascular components were deployed to manage procedural complications including aortic and target vessel dissections and injuries not related to access. Bridging stent grafts were deployed to incorporate 407 target vessels (mean 1.6/per vessel; range, 1-4). Postoperative transfusion was required in 14 patients (13.7%). Major adverse events occurred in seven patients (6.9%) through 30 days. Events included respiratory failure (n = 2), disabling stroke (n = 1), new-onset renal failure requiring dialysis (n = 2), and paraplegia (n = 2). At 30 days, there was one patient with intraoperative rupture; no severe bowel ischemia or lesion-related/all-cause mortality were reported. The Core lab-reported patency was 100% in the aortic component, superior mesenteric artery, and celiac artery, and 95.9% in the left renal and 99.0% in the right renal branch components through 30 days of follow-up. Reinterventions through 30 days were performed in 9 of 96 patients (9.4%) and were all minor. CONCLUSIONS: Early TAMBE device outcomes demonstrate a high technical success rate, no 30-day lesion-related mortality, and a low rate of safety events within 30 days of the index procedure.

Development of the AMPDECIDE Decision Aid to Facilitate Shared Decision Making in Patients Facing Amputation Secondary to Chronic Limb Threatening Ischemia.

INTRODUCTION: We developed a patient decision aid to enhance patient participation in amputation level decision making when there is a choice between a transmetatarsal or transtibial amputation. METHODS: In accordance with International Patient Decision Aid Standards, we developed an amputation level patient decision aid for patients who are being considered for either a transmetatarsal or transtibial amputation, incorporating qualitative literature data, quantitative literature data, qualitative provider and patient interviews, expert panel input and iterative patient feedback. RESULTS: The rapid qualitative literature review and qualitative interviews identified five domains outcome priority domains important to patients facing amputation secondary to chronic limb threatening ischemia: 1) the ability to walk, 2) healing and risk for reamputation, 3) rehabilitation program intensity, 4) ease of prosthetic use, and 5) limb length after amputation. The rapid quantitative review identified only two domains with adequate evidence comparing differences in outcomes between the two amputation levels: mobility and reamputation. Patient, surgeon, rehabilitation and decision aid expert feedback allowed us to integrate critical facets of the decision including addressing the emotional context of loss of limb, fear and anxiety as an obstacle to decision making, shaping the decision in the context of remaining life years, and how to facilitate patient knowledge of value tradeoffs. CONCLUSIONS: Amputation level choice is associated with significant outcome trade-offs. The AMPDECIDE patient decision aid can facilitate acknowledgment of patient fears, enhance knowledge of amputation level outcomes, assist patients in determining their personal outcome priorities, and facilitate shared amputation level decision making.

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

BACKGROUND: 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 prepandemic baseline. METHODS: This study was a retrospective cross-sectional study between 2018 and 2023 using the US Fee-for-Service Medicare 5% National Sample as part of the VA Disrupted Care National Project. We studied patients who underwent 1 of 3 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 prepandemic quarter in 2019. We then performed a subanalysis 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 prepandemic 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 prepandemic 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 prepandemic 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 remains uncertain and necessitates a better understanding of postpandemic care delivery.

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.

Initial Outcomes of the Gore TAG Thoracic Branch Endoprosthesis for Endovascular Repair of Blunt Thoracic Aortic Injury.

BACKGROUND: Endovascular repair of blunt thoracic aortic injury (BTAI) has dramatically reduced the morbidity and mortality of intervention. Injuries requiring zone 2 coverage of the aorta traditionally require left subclavian artery (LSA) sacrifice or open revascularization. Furthermore, these injuries are associated with an increased risk of in-hospital mortality and long-term morbidity. Here we report 1-year outcomes of total endovascular repair of BTAI with the GORE® TAG® Thoracic Branch Endoprosthesis for LSA preservation. METHODS: Across 34 investigative sites, 9 patients with BTAI requiring LSA coverage were enrolled in a nonrandomized, prospective study of a single-branched aortic endograft. The thoracic branch endoprosthesis device allows for graft placement proximal to the LSA and incorporates a single side branch for LSA perfusion. RESULTS: This initial cohort included 8 male and 1 female patient with a median age of 43 (22, 76) and 12 months of follow-up. Five total years of follow-up are planned. All participants had grade 3 BTAI. All procedures took place between 2018 and 2019. The median injury severity score was 2 (0, 66). The median procedure time was 109 min (78, 162). All aortic injuries were repaired under general anesthesia and with heparinization. A spinal drain was used in one patient. Post-deployment balloon angioplasty was conducted in one case at the distal landing zone. There was one asymptomatic LSA branch occlusion 6 months after repair. It was attributed to the purposeful proximal deployment of the branch stent to accommodate an early vertebral takeoff. The occlusion did not require revascularization. There were no strokes, mortalities, or aortic adverse events (migration, endoleak, native aortic expansion, dissection, or thrombosis) through 12 months of follow-up. CONCLUSIONS: Initial cohort outcomes suggest that endovascular repair of zone 2 BTAI is feasible and has favorable outcomes using the thoracic branch device with LSA preservation. Additional cases and longer-term follow-up are required for a definitive assessment of the device's safety and durability in traumatic aortic injuries.

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.

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.

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 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.

Association between sex and long-term outcomes of endovascular treatment for peripheral artery disease.

BACKGROUND: Endovascular peripheral vascular intervention (PVI) has become the primary revascularization technique used for peripheral artery disease (PAD). Yet, there is limited understanding of long-term outcomes of PVI among women versus men. In this study, our objective was to investigate sex differences in the long-term outcomes of patients undergoing PVI. METHODS: We performed a cohort study of patients undergoing PVI for PAD from January 1, 2010 to September 30, 2015 using data in the Vascular Quality Initiative (VQI) registry. Patients were linked to fee-for-service Medicare claims to identify late outcomes including major amputation, reintervention, major adverse limb event (major amputation or reintervention [MALE]), and mortality. Sex differences in outcomes were evaluated using cumulative incidence curves, Gray's test, and mixed effects Cox proportional hazards regression accounting for patient and lesion characteristics using inverse probability weighted estimates. RESULTS: In this cohort of 15,437 patients, 44% (n = 6731) were women. Women were less likely to present with claudication than men (45% vs. 49%, p < 0.001, absolute standardized difference, d = 0.08) or be able to ambulate independently (ambulatory: 70% vs. 76%, p < 0.001, d = 0.14). There were no major sex differences in lesion characteristics, except for an increased frequency of tibial artery treatment in men (23% vs. 18% in women, p < 0.001, d = 0.12). Among patients with claudication, women had a higher risk-adjusted rate of major amputation (hazard ratio [HR] = 1.72, 95% confidence interval [CI]: 1.18-2.49), but a lower risk of mortality (HR = 0.86, 95% CI: 0.75-0.99). There were no sex differences in reintervention or MALE for patients with claudication. However, among patients with chronic limb-threatening ischemia, women had a lower risk-adjusted hazard of major amputation (HR = 0.79, 95% CI: 0.67-0.93), MALE (HR = 0.86, 95% CI: 0.78-0.96), and mortality (HR = 0.86, 95% CI: 0.79-0.94). CONCLUSION: There is significant heterogeneity in PVI outcomes among men and women, especially after stratifying by symptom severity. A lower overall mortality in women with claudication was accompanied by a higher risk of major amputation. Men with chronic limb-threatening ischemia had a higher risk of major amputation, MALE, and mortality. Developing sex-specific approaches to PVI that prioritizes limb outcomes in women can improve the quality of vascular care for men and women.

Mortality Conversations Between Male Veterans and Their Providers Prior to Dysvascular Lower Extremity Amputation.

BACKGROUND: Among patients facing lower extremity amputation due to dysvascular disease, the mortality risk is very high. Given this, as well as the importance of a patient-centered approach to medical care, informing patients about their possible risk of dying may be important during preoperative shared decision-making. The goal of this investigation was to gain an understanding of patient and provider experiences discussing mortality within the context of amputation within the Veterans Health Administration. METHODS: Semistructured interviews were performed with Veterans with peripheral arterial disease and/or diabetes, vascular and podiatric surgeons, and physical medicine and rehabilitation physicians. Interviews were analyzed using team-based content analysis to identify themes related to amputation-level decisions. RESULTS: We interviewed 22 patients and 21 surgeons and physicians and identified 3 themes related to conversations around mortality: (1) both patients and providers report that mortality conversations are not common prior to amputation; (2) while most providers find value in mortality conversations, some express concerns around engaging in these discussions with patients; and (3) some patients perceive mortality conversations as unnecessary, but many are open to engaging in the conversation. CONCLUSIONS: Providers may benefit from introducing the topic with patients, including providing the context for why mortality conversations may be valuable, with the understanding that patients can always decline to participate should they not be interested or comfortable discussing this issue.

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.

Using the Evaluating Devices Using Claims and RegisTry Data (EDUCATe) Plan within the Vascular Implant Surveillance and Interventional Outcomes Network (VISION) to Analyze the Long-Term Outcomes following Endovascular Aortic Aneurysm Repair.

BACKGROUND: Implanted devices undergo clinical trials to assess their safety and effectiveness. However, pivotal device trials are limited in their follow-up while postmarket surveillance may incompletely capture late failure. Linking clinical trials to Medicare claims can address these limitations. This study matched patients from investigational device exemption (IDE) clinical trials for endovascular aortic aneurysm repair (EVAR) to Medicare claims-based registry data to compare long-term device outcomes between the 2 sources. METHODS: Patient-level data from 2 industry-sponsored IDE trials of EVAR devices was provided by a single industry partner. Trial data were matched at the patient level to data from the Vascular Implant Surveillance and Interventional Outcomes Network (VISION), a registry that is a part of the Society for Vascular Surgery Patient Safety Organization. The primary outcomes analyzed were survival and freedom from aneurysm-related reintervention. RESULTS: Of 159 clinical trial patients, 134 were eligible for claims-based matching and 115 (85.5%) were successfully matched to VISION registry data. For the matched cohort, the Kaplan-Meier estimated survival was 94.8% at 1 year, 82.6% at 3 years, and 68.1% at 5 years. Estimates for freedom from reintervention were 90% at 1 year, 82.4% at 3 years, and 78.1% at 5 years. The estimates for survival were nearly identical between the clinical trial data and that found in the VISION data (log-rank P = 0.89). Freedom from reintervention was similar between the groups, with IDE trial reported freedom from reintervention of 87.3% and 73.3%, compared to VISION of 92.6% and 83% at 1 and 5 years, respectively (log-rank P = 0.13). CONCLUSIONS: Clinical trial patients who undergo EVAR can be successfully matched to claims-based registry data to improve long-term device surveillance and outcomes reporting. Claims-based results agreed well with IDE trial results for patients through 5 years, supporting the accuracy of claims-based data for longer-term surveillance. Linking clinical trial and claims-based registry data can lead to robust device monitoring.

Use of linked registry claims data for long term surveillance of devices after endovascular abdominal aortic aneurysm repair: observational surveillance study.

OBJECTIVE: To evaluate long term outcomes (reintervention and late rupture of abdominal aortic aneurysm) of aortic endografts in real world practice using linked registry claims data. DESIGN: Observational surveillance study. SETTING: 282 centers in the Vascular Quality Initiative Registry linked to United States Medicare claims (2003-18). PARTICIPANTS: 20 489 patients treated with four device types used for endovascular abdominal aortic aneurysm repair (EVAR): 40.6% (n=8310) received the Excluder (Gore), 32.2% (n=6606) the Endurant (Medtronic), 16.0% (n=3281) the Zenith (Cook Medical), and 11.2% (n=2292) the AFX (Endologix). Given modifications to AFX in late 2014, patients who received the AFX device were categorized into two groups: the early AFX group (n=942) and late AFX group (n=1350) and compared with patients who received the other devices, using propensity matched Cox models. MAIN OUTCOME MEASURES: Reintervention and rupture of abdominal aortic aneurysm post-EVAR; all patients (100%) had complete follow-up via the registry or claims based outcome assessment, or both. RESULTS: Median age was 76 years (interquartile range (IQR) 70-82 years), 80.0% (16 386/20 489) of patients were men, and median follow-up was 2.3 years (IQR 0.9-4.1 years). Crude five year reintervention rates were significantly higher for patients who received the early AFX device compared with the other devices: 14.9% (95% confidence interval 13.7% to 16.2%) for Excluder, 19.5% (18.1% to 21.1%) for Endurant, 16.7% (15.0% to 18.6%) for Zenith, and early 27.0% (23.7% to 30.6%) for the early AFX. The risk of reintervention for patients who received the early AFX device was higher compared with the other devices in propensity matched Cox models (hazard ratio 1.61, 95% confidence interval 1.29 to 2.02) and analyses using a surgeon level instrumental variable of >33% AFX grafts used in their practice (1.75, 1.19 to 2.59). The linked registry claims surveillance data identified the increased risk of reintervention with the early AFX device as early as mid-2013, well before the first regulatory warnings were issued in the US in 2017. CONCLUSIONS: The linked registry claims surveillance data identified a device specific risk in long term reintervention after EVAR of abdominal aortic aneurysm. Device manufacturers and regulators can leverage linked data sources to actively monitor long term outcomes in real world practice after cardiovascular interventions.

Effect of a Decision Aid on Agreement Between Patient Preferences and Repair Type for Abdominal Aortic Aneurysm: A Randomized Clinical Trial.

Importance: Patients with abdominal aortic aneurysm (AAA) can choose open repair or endovascular repair (EVAR). While EVAR is less invasive, it requires lifelong surveillance and more frequent aneurysm-related reinterventions than open repair. A decision aid may help patients receive their preferred type of AAA repair. Objective: To determine the effect of a decision aid on agreement between patient preference for AAA repair type and the repair type they receive. Design, Setting, and Participants: In this cluster randomized trial, 235 patients were randomized at 22 VA vascular surgery clinics. All patients had AAAs greater than 5.0 cm in diameter and were candidates for both open repair and EVAR. Data were collected from August 2017 to December 2020, and data were analyzed from December 2020 to June 2021. Interventions: Presurgical consultation using a decision aid vs usual care. Main Outcomes and Measures: The primary outcome was the proportion of patients who had agreement between their preference and their repair type, measured using χ2 analyses, κ statistics, and adjusted odds ratios. Results: Of 235 included patients, 234 (99.6%) were male, and the mean (SD) age was 73 (5.9) years. A total of 126 patients were enrolled in the decision aid group, and 109 were enrolled in the control group. Within 2 years after enrollment, 192 (81.7%) underwent repair. Patients were similar between the decision aid and control groups by age, sex, aneurysm size, iliac artery involvement, and Charlson Comorbidity Index score. Patients preferred EVAR over open repair in both groups (96 of 122 [79%] in the decision aid group; 81 of 106 [76%] in the control group; P = .60). Patients in the decision aid group were more likely to receive their preferred repair type than patients in the control group (95% agreement [93 of 98] vs 86% agreement [81 of 94]; P = .03), and κ statistics were higher in the decision aid group (κ = 0.78; 95% CI, 0.60-0.95) compared with the control group (κ = 0.53; 95% CI, 0.32-0.74). Adjusted models confirmed this association (odds ratio of agreement in the decision aid group relative to control group, 2.93; 95% CI, 1.10-7.70). Conclusions and Relevance: Patients exposed to a decision aid were more likely to receive their preferred AAA repair type, suggesting that decision aids can help better align patient preferences and treatments in major cardiovascular procedures. Trial Registration: ClinicalTrials.gov Identifier: NCT03115346.

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.