Long-term outcomes of carotid endarterectomy vs transfemoral carotid stenting in a Medicare-matched database.

BACKGROUND: Carotid endarterectomy (CEA) is associated with lower risk of perioperative stroke compared with transfemoral carotid artery stenting (TFCAS) in the treatment of carotid artery stenosis. However, there is discrepancy in data regarding long-term outcomes. We aimed to compare long-term outcomes of CEA vs TFCAS using the Medicare-matched Vascular Quality Initiative Vascular Implant Surveillance and Interventional Outcomes Network database. METHODS: We assessed patients undergoing first-time CEA or TFCAS in Vascular Quality Initiative Vascular-Vascular Implant Surveillance and Interventional Outcomes Network from January 2003 to December 2018. Patients with prior history of carotid revascularization, nontransfemoral stenting, stenting performed without distal embolic protection, multiple or nonatherosclerotic lesions, or concomitant procedures were excluded. The primary outcome of interest was all-cause mortality, any stroke, and a combined end point of death or stroke. We additionally performed propensity score matching and stratification based on symptomatic status. RESULTS: A total of 80,146 carotid revascularizations were performed, of which 72,615 were CEA and 7531 were TFCAS. CEA was associated with significantly lower risk of death (57.8% vs 70.4%, adjusted hazard ratio [aHR], 0.46; 95% confidence interval [CI], 0.41-0.52; P < .001), stroke (21.3% vs 26.6%; aHR, 0.63; 95% CI, 0.57-0.69; P < .001) and combined end point of death and stroke (65.3% vs 76.5%; HR, 0.49; 95% CI, 0.44-0.55; P < .001) at 10 years. These findings were reflected in the propensity-matched cohort (combined end point: 34.6% vs 46.8%; HR, 0.53; 95% CI, 0.46-0.62) at 4 years, as well as stratified analyses of combined end point by symptomatic status (asymptomatic: 63.2% vs 74.9%; HR, 0.49; 95% CI, 0.43-0.58; P < .001; symptomatic: 69.9% vs 78.3%; HR, 0.51; 95% CI, 0.45-0.59; P < .001) at 10 years. CONCLUSIONS: In this analysis of North American real-world data, CEA was associated with greater long-term survival and fewer strokes compared with TFCAS. These findings support the continued use of CEA as the first-line revascularization procedure.

The association of ruptured abdominal aortic aneurysm diameter with mortality in the International Consortium of Vascular Registries.

BACKGROUND: The mortality after ruptured abdominal aortic aneurysm (rAAA) repair is high, despite improvements in perioperative care, centralization of emergency vascular surgical services, and the introduction of endovascular aneurysm repair (EVAR). The diameter of intact AAA has been shown to be a predictor of short- and long-term survival. The aim of this study was to analyze the impact of AAA diameter on mortality for rAAA repair using contemporary data collected from the International Consortium of Vascular Registries and compare outcomes by sex and the type of repair patients received. METHODS: Prospective registry data on repair of rAAA from seven countries were collected from 2010 to 2016. The primary outcome was perioperative mortality after EVAR and open surgical repair (OSR). Data were stratified by type of repair and sex. Logistic regression models were used to estimate odds ratio (OR) for the association between AAA diameter and perioperative mortality and the association between type of repair and mortality. Multivariable logistic regression models were used to adjust for differences in patient characteristics. RESULTS: The study population consisted of 6428 patients with a mean age ranging from 70.2 to 75.4 years; the mean AAA diameter was 7.7 ± 1.8 cm. Females had a significantly smaller AAA diameter at presentation compared with males (6.9 ± 1.6 cm vs 7.9 ± 1.8 cm; P < .001). who underwent OSR had larger AAA diameters compared with those who underwent EVAR (P < .001). Females who underwent repair were significantly older (P < .001). Males were more likely to have cardiac disease, diabetes mellitus, and renal impairment. Overall, AAA diameter was a predictor of mortality in univariate and multivariate analysis. When analyzing EVAR and OSR separately, the impact of AAA diameter per cm increase on mortality was apparent in both males and females undergoing EVAR, but not OSR (EVAR: male OR, 1.09 [95% confidence interval, 1.03-1.16] and EVAR: female OR, 1.17 [95% confidence interval, 1.02-1.35]). The early mortality rate for males and females who underwent EVAR was 18.9% and 25.9% (P < .001), respectively. The corresponding mortality for males and females who underwent OSR was 30.2% and 38.6% (P < .001), respectively. CONCLUSIONS: In these real-world international data, there is a significant association between rAAA diameters and early mortality in males and females. This association was more evident in patients undergoing EVAR, but not shown in OSR. Despite improvements in overall AAA repair outcomes, the risk of mortality after rAAA repair is consistently higher for females.

Short-Term Out-of-Pocket and Total Costs of Care After Ablation, Resection, or Transplant for Early-Stage Hepatocellular Carcinoma: A National SEER-Medicare Cost Comparison.

Background: Differences in survival and morbidity among treatment options (ablation, surgical resection, and transplant) for early-stage hepatocellular carcinoma (HCC) have been well-studied. Additional understanding of the costs of such care would help to identify drivers of high costs and potential barriers to care delivery. Objective: To quantify total and patient out-of-pocket costs for ablation, surgical resection, and transplant in the management of early-stage HCC and to identify factors predictive of these costs. Methods: This retrospective U.S. population-based study used the SEER-Medicare linked dataset to identify a sample of 1067 Medicare beneficiaries (mean age, 73 years; 674 men, 393 women) diagnosed with early-stage HCC (size ≤5 cm) treated with ablation (N=623), resection (N=201), or transplant (N=243) between January 2009 and December 2016. Total costs and patient out-of-pocket costs for the index procedure as well as for any care within 30 days and 90 days post-procedure were identified and stratified by treatment modality. Additional comparisons were performed among propensity-score matched subgroups of patients treated by ablation or resection (each N=172). Multivariable linear regression models were used to identify factors predictive of total costs and out-of-pocket costs for index procedures as well as for 30-day and 90-day post-procedure periods. Results: For ablation, resection, and transplant, median index-procedure total cost was $6689, $25,614, and $66,034; index-procedure out-of-pocket cost was $1235, $1650, and $1317; 30-day total cost was $9456, $29,754, and $69,856; 30-day out-of-pocket cost was $1646, $2208, and $3198; 90-day total cost was $14,572, $34,984, and $88,103; and 90-day out-of-pocket cost was $2138, $2462, and $3876, respectively (all p<.001). In propensity-matched subgroups, ablation and resection had median index-procedure, 30-day, and 90-day total costs of $6690 and $25,716, $9995 and $30,365, and $15,851 and $34,455, respectively. In multivariable analysis adjusting for socioeconomic factors, comorbidities, and liver-disease prognostic indicators, surgical treatment (resection or transplant) was predictive of significantly greater costs compared with ablation at all time points. Conclusion: Total and out-of-pocket costs for index procedures as well as for 30-day and 90-day post-procedure periods were lowest for ablation, followed by resection and then transplant. Clinical Impact: This comprehensive cost analysis could help inform future cost-effectiveness analyses.

Contemporary Assessment of Adhesiolysis and Resection for Adhesive Small Bowel Obstruction in the State of New York.

BACKGROUND: Adhesive small bowel obstruction (aSBO) is a common surgical problem, with some advocating for a more aggressive operative approach to avoid recurrence. Contemporary outcomes in a real-world setting were examined. STUDY DESIGN: A retrospective cohort study was performed using the New York Statewide Planning and Research Cooperative database to identify adults admitted with aSBO, 2016-2020. Patients were stratified by the presence of inflammatory bowel disease (IBD) and cancer history. Diagnoses usually requiring resection were excluded. Patients were categorized into four groups: non-operative, adhesiolysis, resection, and 'other' procedures. In-hospital mortality, major complications, and odds of undergoing resection were compared. RESULTS: 58,976 patients were included. 50,000 (84.8%) underwent non-operative management. Adhesiolysis was the most common procedure performed (n = 4,990, 8.46%), followed by resection (n = 3,078, 5.22%). In-hospital mortality in the lysis and resection groups was 2.2% and 5.9% respectively. Non-IBD patients undergoing operation on the day of admission required intestinal resection 29.9% of the time. Adjusted odds of resection were highest for those with a prior aSBO episode (OR 1.29 95%CI 1.11-1.49), delay to operation ≥3 days (OR1.78 95%CI 1.58-1.99), and non-New York City (NYC) residents being treated at NYC hospitals (OR1.57 95%CI 1.19-2.07). CONCLUSION: Adhesiolysis is currently the most common surgery for aSBO, however nearly one-third of patients will undergo a more extensive procedure, with an increased risk of mortality. Innovative therapies are needed to reduce the risk of resection.

Long-Term Outcomes Following Elective Repair of Intact Abdominal Aortic Aneurysms: A Comparison Between Open Surgical and Endovascular Repair Using Linked Administrative and Clinical Registry Data.

OBJECTIVE: Compare long-term mortality, secondary intervention and secondary rupture following elective endovascular aneurysm repair (EVAR) and open surgical repair (OSR). BACKGROUND: EVAR has surpassed OSR as the most common procedure used to repair abdominal aortic aneurysm (AAA), but evidence regarding long-term outcomes is inconclusive. METHODS: We included patients in linked clinical registry and administrative data undergoing EVAR or OSR for intact AAA between January 2010 and June 2019. We used an inverse probability of treatment-weighted survival analysis to compare all-cause mortality, cause-specific mortality, secondary interventions and secondary rupture, and evaluate the impact of secondary interventions and secondary rupture on all-cause mortality. RESULTS: The study included 3460 EVAR and 427 OSR patients. Compared to OSR, the EVAR all-cause mortality rate was lower in the first 30 days [adjusted hazard ratio (HR) = 0.22, 95% confidence interval (CI) 0.140.33], but higher between 1 and 4 years (HR = 1.29, 95% CI 1.12-1.48) and after 4years (HR = 1.41, 95% CI 1.23-1.63). Secondary intervention rates were higher over the first 30 days (HR = 2.26, 95% CI 1.11-4.59), but lower between 1 and 4years (HR = 0.59, 95% CI 0.48-0.74). Secondary aortic intervention rates were higher across the entire follow-up period (HR = 2.52, 95% CI 2.06-3.07). Secondary rupture rates did not differ significantly (HR = 1.06, 95% CI 0.73-1.55). All-cause mortality beyond 1 year remained significantly higher for EVAR after adjusting for any secondary interventions, or secendary rupture. CONCLUSIONS: EVAR has an early survival benefit compared to OSR. However, elevated long-term mortality and higher rates of secondary aortic interventions and subsequent aneurysm repair suggest that EVAR may be a less durable method of aortic aneurysm exclusion.

Long-term Mortality and Reintervention After Endovascular and Open Abdominal Aortic Aneurysm Repairs in Australia, Germany, and the United States.

OBJECTIVE: To examine long-term outcomes after endovascular (EVAR) and open repairs (OAR) for intact abdominal aortic aneurysms in Australia, Germany, and the United States, using a unified study design. BACKGROUND: Similarities and differences in long-term outcomes after EVAR versus OAR across countries remained unclear, given differences in designs across existing studies. METHODS: We identified patients aged >65 years undergoing intact abdominal aortic aneurysm repairs during 2010-2017/2018. We compared long-term patient mortality and reintervention after EVAR and OAR using Kaplan-Meier analyses and Cox regressions. Propensity score matching was performed within each country to adjust for differences in baseline patient characteristics between procedure groups. RESULTS: We included 3311, 4909, and 145363 patients from Australia, Germany, and the United States, respectively. The median patient age was 76 to 77 years, and most patients were males (77%-84%). Patient mortality was lower after EVAR than OAR within the first 60 days and became similar at 3-year follow-up (Australia 14.7% vs 16.5%, Germany 18.2% vs 19.7%, United States: 24.4% vs 24.4%). At the end of follow-up, patient mortality after EVAR was higher than OAR in Australia [ hazard ratio (HR) 95% CI: 1.21 (0.96-1.54)] but similar to OAR in Germany [HR 95% CI: 0.92 (0.80-1.07)] and the United States [HR 95% CI: 1.02 (0.99-1.05)]. The risk of reintervention after EVAR was more than twice that after OAR in Australia [HR 95% CI: 2.60 (1.09-6.15)], Germany [HR 95% CI: 4.79 (2.56-8.98)], and the United States [HR 95% CI: 2.67 (2.38-3.00)]. The difference in reintervention risk appeared early in German and United States patients. CONCLUSIONS: This multinational study demonstrated important similarities in long-term outcomes after EVAR versus OAR across 3 countries. Variation in long-term mortality and reintervention comparisons indicates possible differences in patient profiles, surveillance, and best medical therapy across countries.

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.

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.

Prostatic artery embolization compared to transurethral resection of the prostate and prostatic urethral lift: a real-world population-based study.

BACKGROUND: There are growing interests for minimally invasive surgical techniques (MISTs) for the treatment of benign prostatic hyperplasia (BPH)-associated lower urinary tract symptoms (LUTS). Prostatic artery embolization (PAE) uses selective angioembolization of prostatic arteries, thereby reducing size to improve LUTS/BPH. However, real-world data comparing surgical outcomes between MISTs and tissue resective techniques are lacking. We assessed the differences in surgical outcomes between PAE, transurethral resection of the prostate (TURP), and prostatic urethral lift (PUL) in a real-world population for LUTS/BPH. METHODS: We present an observational population-based study of 12,902 men with BPH in New York State who received PAE, TURP, and PUL in outpatient and ambulatory surgery settings from 2014 to 2018. For short-term outcomes, we report 30-day and 90-day risks of readmission to inpatient and emergency room (ER) with/without complications and compared them across groups using χ2 tests and mixed-effect logistic regressions. For long-term outcomes, we report surgical retreatment and stricture rates using Kaplan-Meier failure curves and compared them using Log rank tests and Cox regression models. RESULTS: Of 12 902 men, 335 had PAE, 11,205 had TURP, and 1362 had PUL. PAE patients had the highest 30-day (19.9%) and 90-day (35.6%) risks of readmission to inpatient or ER (p < 0.01). Non-specific abdominal pain was the main diagnosis associated with 30-day and 90-day readmissions to inpatient or ER after PAE (14.3% and 26.8%, respectively). After 2 years of follow-up, PAE patients had the highest retreatment rate of 28.5% (95%CI 23.7-34.2%) compared to TURP (3.4% (95%CI 3.1-3.8%)) and PUL (8.5% (95%CI 5.6-12.9%)) (p < 0.001). CONCLUSION: In a real-world population, PAE was associated with the most frequent 30-day and 90-day readmission to inpatient or ER and the highest retreatment rate among all surgical techniques even when controlled for individual patient comorbidities and surgical volume.

Real-World Safety Analysis of Paclitaxel Devices Used for the Treatment of Peripheral Artery Disease.

PURPOSE: To investigate the real-world safety of paclitaxel (PTX)-coated devices for treating lower extremity peripheral artery disease using a commercial claims database. MATERIALS AND METHODS: Data from FAIR Health, the largest commercial claims data warehouse in the United States, were used for this study. The study consisted of patients who underwent femoropopliteal revascularization procedures between January 1, 2015, and December 31, 2019, with PTX and non-PTX devices. The primary outcome was 4-year survival following treatment. The secondary outcomes included 2-year survival, 2- and 4-year freedom from amputation, and repeat revascularization. Propensity score matching was used to minimize confounding, and the Kaplan-Meier methods were used to estimate survival. RESULTS: A total of 10,832 procedures were included in the analysis, including 4,962 involving PTX devices and 5,870 involving non-PTX devices. PTX devices were associated with a reduced hazard of death following treatment at 2 and 4 years (hazard ratio [HR], 0.74 [95% confidence interval {CI}, 0.69-0.79]; P <.05, and HR, 0.89 [95% CI, 0.77-1.02]; log-rank P =.018, respectively). The risk of amputation was also lower following treatment with PTX devices than with non-PTX devices at 2 and 4 years (HR, 0.82 [95% CI, 0.76-0.87]; P =.02, and HR, 0.77 [95% CI, 0.67-0.89]; log-rank P =.01, respectively). In addition, the odds of repeat revascularization were similar with PTX and non-PTX devices at 2 and 4 years. CONCLUSIONS: In the real-world commercial claims database, no short- or long-term signal for increased mortality or amputations was observed following treatment with PTX devices.

Beyond Survival: Adverse Events and Care Delivery Outcomes after Early Liver Cancer Treatment in a Nationally Representative Cohort.

PURPOSE: To compare secondary outcomes after ablation (AB), surgical resection (SR), and liver transplant (LT) for small hepatocellular carcinomas (HCCs), including resource utilization and adverse event (AE) rates. MATERIALS AND METHODS: Using Surveillance, Epidemiology, and End Results Program (SEER)-Medicare, HCCs <5 cm that were treated with AB, SR, or LT in 2009-2016 (n = 1,067) were identified using Healthcare Common Procedure Coding System codes through Medicare claims. Index procedure length of stay, need for intensive care unit (ICU) level care, readmission rates, and AE rates at 30 and 90 days were compared using chi-square tests or Fisher exact tests. Examined AEs included hemorrhage, abscess formation, biliary injury, pneumonia, sepsis, liver disease-related AEs, liver failure, and anesthesia-related AEs, identified by International Classification of Diseases, Ninth/10th Revision, codes. RESULTS: The median length of stay for initial treatment was 1 day, 6 days, and 7 days for AB, SR, and LT, respectively (P < .001). During initial hospital stay, 5.0%, 40.8%, and 63.4% of AB, SR, and LT cohorts, respectively, received ICU-level care (P < .001). By 30 and 90 days, there were significant differences among the AB, SR, and LT cohorts in the rate of postprocedural hemorrhage, abscess formation, biliary injury, pneumonia, sepsis, liver disease-related AEs, and anesthesia-related AEs (P < .05). By 90 days, the readmission rates after AB, SR, and LT were 18.6%, 28.2%, and 40.6% (P < .001), respectively. CONCLUSIONS: AB results in significantly less healthcare utilization during the initial 90 days after procedure compared with that after SR and LT due to shorter length of stay, lower intensity care, fewer readmissions, and fewer AEs.

Editor's Choice - Real World Study of Mortality After the Use of Paclitaxel Coated Devices in Peripheral Vascular Intervention.

OBJECTIVE: This observational cohort study examined outcomes after peripheral vascular intervention (PVI) with paclitaxel coated devices (PCD) and non-PCD, and evaluated heterogeneity of treatment effect in populations of interest. METHODS: The study included patients undergoing percutaneous transluminal angioplasty and or stent placement between 1 October 2015 and 31 December 2018 in the Vascular Quality Initiative Registry linked to Medicare claims. It determined differences in patient mortality and ipsilateral major amputation after PVI with PCD and non-PCD using Kaplan-Meier analyses and Cox regressions with inverse probability weighting in three cohorts: (A) patients treated for femoropopliteal or infrapopliteal occlusive disease with or without any other concurrent treatment (n = 11 452); (B) those treated for isolated superficial femoral or popliteal artery disease (n = 5 519); and (C) patients with inclusion criteria designed to approximate RCT populations (n = 2 278). RESULTS: The mean age of patients was 72.3 (SD = 10.9) years, and 40.6% were female. In cohort A, patients receiving PCD had a lower mortality rate (HR 0.88, 95% CI 0.79 - 0.98) than those receiving non-PCD. There was no significant difference in mortality between groups in cohort B (HR 0.91, 95% CI 0.80 - 1.04) and cohort C (HR 1.10, 95% CI 0.84 - 1.43). Patients receiving PCD did not have a significantly elevated risk of major amputation compared with those receiving non-PCD (cohort A: HR 0.84, 95% CI 0.70 - 1.00; cohort B: HR 0.84, 95% CI 0.67 - 1.06; and cohort C: HR 1.05, 95% CI 0.51 - 2.14). CONCLUSION: No increased patient mortality or major amputation was found at three years after PVI with PCD vs. non-PCD in this large, linked registry claims study, after accounting for heterogeneity of treatment effect by population. The analysis and results from three cohorts intended to mirror the cohorts of previous studies provide robust and niche real world evidence on PCD safety and help to understand and reconcile previously discrepant findings.

Editor's Choice - Comparison of Outcomes for Major Contemporary Endograft Devices Used for Endovascular Repair of Intact Abdominal Aortic Aneurysms.

OBJECTIVE: To compare rates of mortality, rupture, and secondary intervention following endovascular repair (EVAR) of intact abdominal aortic aneurysms (AAA) using contemporary endograft devices from three major manufacturers. METHODS: This was a retrospective cohort study using linked clinical registry (Australasian Vascular Audit) and all payer administrative data. Patients undergoing EVAR for intact AAA between 2010 and 2019 in New South Wales, Australia were identified. Rates of all cause death, secondary rupture, and secondary intervention (subsequent aneurysm repair; other secondary aortic intervention) were compared for patients treated with Cook, Medtronic, and Gore standard devices. Inverse probability of treatment weighted proportional hazards and competing risk regression were used to adjust for patient, clinical, and aneurysm characteristics, using Cook as the referent device. RESULTS: This study identified 2 874 eligible EVAR patients, with a median follow up of 4.1 (maximum 9.5) years. Mortality rates were similar for patients receiving different devices (ranging between 7.0 and 7.3 per 100 person years). There was no statistically significant difference between devices in secondary rupture rates, which ranged between 0.4 and 0.5 per 100 person years. Patients receiving Medtronic and Gore devices tended to have higher crude rates of subsequent aneurysm repair (1.5 per 100 person years) than patients receiving Cook devices (0.8 per 100 person years). This finding remained in the adjusted analysis, but was only statistically significant for Medtronic devices (HR 1.57, 95% CI 1.02 - 2.47; HR 1.73, 95% CI 0.94 - 3.18, respectively). CONCLUSION: Major endograft devices have similar overall long term safety profiles. However, there may be differences in rates of secondary intervention for some devices. This may reflect endograft durability, or patient selection for different devices based on aneurysm anatomy. Continuous comparative assessments are needed to guide evidence for treatment decisions across the range of available devices.

Simulating complex patient populations with hierarchical learning effects to support methods development for post-market surveillance.

BACKGROUND: Validating new algorithms, such as methods to disentangle intrinsic treatment risk from risk associated with experiential learning of novel treatments, often requires knowing the ground truth for data characteristics under investigation. Since the ground truth is inaccessible in real world data, simulation studies using synthetic datasets that mimic complex clinical environments are essential. We describe and evaluate a generalizable framework for injecting hierarchical learning effects within a robust data generation process that incorporates the magnitude of intrinsic risk and accounts for known critical elements in clinical data relationships. METHODS: We present a multi-step data generating process with customizable options and flexible modules to support a variety of simulation requirements. Synthetic patients with nonlinear and correlated features are assigned to provider and institution case series. The probability of treatment and outcome assignment are associated with patient features based on user definitions. Risk due to experiential learning by providers and/or institutions when novel treatments are introduced is injected at various speeds and magnitudes. To further reflect real-world complexity, users can request missing values and omitted variables. We illustrate an implementation of our method in a case study using MIMIC-III data for reference patient feature distributions. RESULTS: Realized data characteristics in the simulated data reflected specified values. Apparent deviations in treatment effects and feature distributions, though not statistically significant, were most common in small datasets (n < 3000) and attributable to random noise and variability in estimating realized values in small samples. When learning effects were specified, synthetic datasets exhibited changes in the probability of an adverse outcomes as cases accrued for the treatment group impacted by learning and stable probabilities as cases accrued for the treatment group not affected by learning. CONCLUSIONS: Our framework extends clinical data simulation techniques beyond generation of patient features to incorporate hierarchical learning effects. This enables the complex simulation studies required to develop and rigorously test algorithms developed to disentangle treatment safety signals from the effects of experiential learning. By supporting such efforts, this work can help identify training opportunities, avoid unwarranted restriction of access to medical advances, and hasten treatment improvements.

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.

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.

Disparities in 5-year outcomes and imaging surveillance following elective endovascular repair of abdominal aortic aneurysm by sex, race, and ethnicity.

OBJECTIVES: Sex, racial, and ethnic disparities in postoperative outcomes following abdominal aortic aneurysm repair have been described, but differences in long-term outcomes are poorly understood. Our aim was to identify differences in 5-year outcomes and imaging surveillance after elective endovascular aortic aneurysm repair (EVAR) by sex, race, and ethnicity and to explore potential mechanisms underlying these differences. METHODS: We identified patients undergoing elective EVAR in the Vascular Quality Initiative from 2003 to 2017 with linkage to Medicare claims through 2018 for long-term outcomes. Our primary outcome was 5-year aneurysm rupture. Secondary outcomes were 5-year reintervention and mortality and 2-year loss-to-imaging follow-up (defined as no aortic imaging from 6 to 24 months after EVAR). We used Kaplan-Meier and Cox regression analyses to evaluate these outcomes by sex/race/ethnicity and constructed multivariable models to explore potential contributing factors. RESULTS: Among 16,040 patients, 11,764 (73%) were White males, 2891 (18%) were White females, 417 (2.6%) were Black males, 175 (1.1%) were Black females, 141 (0.9%) were Asian males, 34 (0.2%) were Asian females, 277 (1.7%) were Hispanic males, and 60 (0.4%) were Hispanic females. At 5 years, rupture rates were highest in Black females at 6.4% and lowest in white males at 2.3%. Compared with White males, rupture rates were higher in White females (hazard ratio [HR], 1.5; 95% confidence interval [CI], 1.1-2.0), Black females (HR, 2.5; 95% CI, 1.0-6.0), and Asian females (HR, 5.2; 95% CI, 1.3-21). White females also had higher mortality (HR, 1.2; 95% CI, 1.2-1.3) and loss-to-imaging-follow-up (HR, 1.2; 95% CI, 1.1-1.3), whereas Black females had higher mortality (HR, 1.4; 95% CI, 1.1-1.8) and reintervention (HR, 2.0; 95% CI, 1.4-2.8). Among other groups, Black males had higher reintervention (HR, 1.4; 95% CI, 1.0-1.8), and both Black and Hispanic males had higher loss-to-imaging-follow-up (Black: HR, 1.4; 95% CI, 1.1-1.7; Hispanic: HR, 1.3; 95% CI, 1.0-1.8). In adjusted analyses, White, Black, and Asian females remained at significantly higher risk for 5-year rupture after accounting for procedure year, clinical and anatomic characteristics, surgeon and hospital volume, and loss-to-imaging follow-up. CONCLUSIONS: Compared with White male patients, Black females had higher 5-year aneurysm rupture, reintervention, and mortality after elective EVAR, whereas White females had higher rupture, mortality and loss-to-imaging-follow-up. Asian females also had higher rupture, and Black males had higher reintervention and loss-to-imaging-follow-up. These populations may benefit from improved preoperative counseling and clinical outreach after EVAR. A larger-scale investigation of current practice patterns and their impact on sex, racial, and ethnic disparities in late outcomes after EVAR is needed to identify tangible targets for improvement.

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.

Real-world data comparing minimally invasive surgeries for benign prostatic hyperplasia.

OBJECTIVES: To assess the differences in surgical outcomes between the prostatic urethral lift (PUL) and previous thermal energy procedures for the treatment of benign prostatic hyperplasia (BPH). METHODS: We present an observational population-based study of 2694 men with BPH in New York State and California who received PUL, transurethral needle ablation (TUNA), or transurethral microwave therapy (TUMT) in outpatient and ambulatory surgery settings from 2005 to 2018. For these surgical procedures, short-term outcomes were reported and compared using a Chi-square test and mixed-effect logistic regressions. Long-term outcomes were described using Kaplan-Meier failure curves and compared using a Log-rank test and Cox regressions. RESULTS: A significant portion of PUL patients had a comorbidity count ≥ 2 (n = 838, 37.0%). PUL exhibited the lowest 30 day and 90-day inpatient or ER readmission rates among all surgical techniques except for 90-day ER readmission (p < 0.05). No differences were observed for 1- and 3-year risks of reoperation between PUL [5.5% (95% CI 4.4-6.8%) and 14.9% (95% CI 10.9-20.1%)], TUNA [7.4% (95% CI 5.0-10.9%) and 11.3% (95% CI 8.3-15.4%)] and TUMT [8.5% (95% CI 4.7-15.2%) and 15.3% (95% CI 9.5-24.0%)]. 1- and 3-year risks of stricture development for PUL were 0.2% (95% CI 0.0-0.7%) and 0.2% (95% CI 0.0-0.07%), respectively. CONCLUSION: In a patient population with chronic conditions, patients treated with PUL exhibited similar 30- and 90-day inpatient or ER readmission rates when compared to previous reports. However, 1- and 3-year reoperation risks for PUL closely resembled previous thermal energy surgical procedures.

Development of a North American coordinated registry network for surgical treatment of benign prostatic hyperplasia.

PURPOSE: To create a prospective, multicenter coordinated registry network (CRN) of robust "real world" data for benign prostatic hyperplasia (BPH) that links surgical practices to objective and subjective outcomes of patients who undergo surgery for the improvement in lower urinary tract symptoms (LUTS) secondary to BPH. METHODS: We gathered a group of BPH experts from various institutions to identify the minimum core data elements needed to assess BPH procedures. To achieve consensus on the data elements, we used a Delphi method adaptation, in which a series of surveys were answered by the expert panel individually and anonymously. Survey results were collected and analyzed. Questions for the following round were based on response analysis from the prior survey. This process was repeated until consensus was achieved. RESULTS: Participation rates in the first and second rounds were 100% and 90%, respectively. The expert panel reached consensus on 148 data elements out of the 182 proposed, capturing patient medical and surgical history, procedure, discharge, short- and long-term follow-up, device factors, surgery, and surgeon factors. CONCLUSION: We have successfully developed a set of core data elements to support the study of BPH surgical therapies by gathering an expert panel on BPH and using the Delphi method. These data elements influence provider decisions about treatment and include important outcomes related to efficacy and safety.