Preparing Patients for Oral Immunotherapy (PPOINT): International Delphi consensus for procedural preparation and consent.

BACKGROUND: Despite the promise of oral immunotherapy (OIT) to treat food allergies, this procedure is associated with potential risk. There is no current agreement about what elements should be included in the preparatory or consent process. OBJECTIVE: We developed consensus recommendations about the OIT process considerations and patient-specific factors that should be addressed before initiating OIT and developed a consensus OIT consent process and information form. METHODS: We convened a 36-member Preparing Patients for Oral Immunotherapy (PPOINT) panel of allergy experts to develop a consensus OIT patient preparation, informed consent process, and framework form. Consensus for themes and statements was reached using Delphi methodology, and the consent information form was developed. RESULTS: The expert panel reached consensus for 4 themes and 103 statements specific to OIT preparatory procedures, of which 76 statements reached consensus for inclusion specific to the following themes: general considerations for counseling patients about OIT; patient- and family-specific factors that should be addressed before initiating OIT and during OIT; indications for initiating OIT; and potential contraindications and precautions for OIT. The panel reached consensus on 9 OIT consent form themes: benefits, risks, outcomes, alternatives, risk mitigation, difficulties/challenges, discontinuation, office policies, and long-term management. From these themes, 219 statements were proposed, of which 189 reached consensus, and 71 were included on the consent information form. CONCLUSION: We developed consensus recommendations to prepare and counsel patients for safe and effective OIT in clinical practice with evidence-based risk mitigation. Adoption of these recommendations may help standardize clinical care and improve patient outcomes and quality of life.

Earned outcomes correlate with reliability-adjusted surgical mortality after abdominal aortic aneurysm repair and predict future performance.

OBJECTIVE: Cumulative, probability-based metrics are regularly used to measure quality in professional sports, but these methods have not been applied to health care delivery. These techniques have the potential to be particularly useful in describing surgical quality, where case volume is variable and outcomes tend to be dominated by statistical "noise." The established statistical technique used to adjust for differences in case volume is reliability-adjustment, which emphasizes statistical "signal" but has several limitations. We sought to validate a novel measure of surgical quality based on earned outcomes methods (deaths above average [DAA]) against reliability-adjusted mortality rates, using abdominal aortic aneurysm (AAA) repair outcomes to illustrate the measure's performance. METHODS: Earned outcomes methods were used to calculate the outcome of interest for each patient: DAA. Hospital-level DAA was calculated for non-ruptured open AAA repair and endovascular aortic repair (EVAR) in the Vascular Quality Initiative database from 2016 to 2019. DAA for each center is the sum of observed - predicted risk of death for each patient; predicted risk of death was calculated using established multivariable logistic regression modeling. Correlations of DAA with reliability-adjusted mortality rates and procedure volume were determined. Because an accurate quality metric should correlate with future results, outcomes from 2016 to 2017 were used to categorize hospital quality based on: (1) risk-adjusted mortality; (2) risk- and reliability-adjusted mortality; and (3) DAA. The best performing quality metric was determined by comparing the ability of these categories to predict 2018 to 2019 risk-adjusted outcomes. RESULTS: During the study period, 3734 patients underwent open repair (106 hospitals), and 20,680 patients underwent EVAR (183 hospitals). DAA was closely correlated with reliability-adjusted mortality rates for open repair (r = 0.94; P < .001) and EVAR (r = 0.99; P < .001). DAA also correlated with hospital case volume for open repair (r = -.54; P < .001), but not EVAR (r = 0.07; P = .3). In 2016 to 2017, most hospitals had 0% mortality (55% open repair, 57% EVAR), making it impossible to evaluate these hospitals using traditional risk-adjusted mortality rates alone. Further, zero mortality hospitals in 2016 to 2017 did not demonstrate improved outcomes in 2018 to 2019 for open repair (3.8% vs 4.6%; P = .5) or EVAR (0.8% vs 1.0%; P = .2) compared with all other hospitals. In contrast to traditional risk-adjustment, 2016 to 2017 DAA evenly divided centers into quality quartiles that predicted 2018 to 2019 performance with increased mortality rate associated with each decrement in quality quartile (Q1, 3.2%; Q2, 4.0%; Q3, 5.1%; Q4, 6.0%). There was a significantly higher risk of mortality at worst quartile open repair hospitals compared with best quartile hospitals (odds ratio, 2.01; 95% confidence interval, 1.07-3.76; P = .03). Using 2016 to 2019 DAA to define quality, highest quality quartile open repair hospitals had lower median DAA compared with lowest quality quartile hospitals (-1.18 DAA vs +1.32 DAA; P < .001), correlating with lower median reliability-adjusted mortality rates (3.6% vs 5.1%; P < .001). CONCLUSIONS: Adjustment for differences in hospital volume is essential when measuring hospital-level outcomes. Earned outcomes accurately categorize hospital quality and correlate with reliability-adjustment but are easier to calculate and interpret. From 2016 to 2019, highest quality open AAA repair hospitals prevented >40 perioperative deaths compared with the average hospital, and >80 perioperative deaths compared with lowest quality hospitals.

Polyvascular disease is common in patients undergoing carotid endarterectomy and lower extremity bypass and is associated with worse outcomes.

BACKGROUND: Polyvascular disease is strongly associated with increased risk of cardiovascular morbidity and mortality. However, its prevalence in patients undergoing carotid and lower extremity surgical revascularization and its impact on outcomes are unknown. METHODS: The Vascular Quality Initiative was queried for carotid endarterectomy (CEA) or infrainguinal lower extremity bypass (LEB), 2013-2019. Polyvascular disease was defined as presence of atherosclerotic occlusive disease in more than one arterial bed: carotid, coronary, and infrainguinal. Primary outcomes were (1) composite perioperative myocardial infarction (MI) or death and (2) 5-year survival. Patient characteristics and perioperative outcomes were evaluated using the χ2 test and multivariable logistic regression. Survival was analyzed using Kaplan-Meier method and Cox proportional hazards multivariable models. RESULTS: Polyvascular disease was identified in 47% of CEA (39.0% in 2 arterial beds, 7.6% in 3 arterial beds; n = 93,736) and 47% of LEB (41.0% in 2 arterial beds, 5.7% in 3 arterial beds; n = 25,223). For both CEA and LEB, patients with polyvascular disease had more comorbidities including hypertension, congestive heart disease, chronic obstructive pulmonary disease, smoking, diabetes mellitus, and end-stage renal disease (P < .0001). Perioperative MI/death rates increased with increasing number of vascular beds affected following CEA (0.9% in 1 bed vs 1.5% in 2 beds vs 2.7% in 3 beds; P < .001) and LEB (2.2% in 1 bed vs 5.3% in 2 beds vs 6.6% in 3 beds; P < .001). Polyvascular disease was associated independently with perioperative MI/death after CEA (odds ratio, 1.59; 95% confidence interval [CI], 1.40-1.81;P < .0001) and LEB (odds ratio, 1.78; 95% CI, 1.52-2.08; P < .0001). Five-year survival was decreased in patients with polyvascular disease after CEA (82% in 3 beds vs 88% in 2 beds vs 92% in 1 bed; P < .01) and LEB (72% in 3 beds vs 75% in 2 beds vs 84% in 1 bed; P < .01) in a dose-dependent manner, with the lowest 5-year survival observed in those with three arterial beds involved. Polyvascular disease was independently associated with 5-year mortality after CEA (hazard ratio, 1.33; 95% CI, 1.24-1.40; P = .0001) and LEB (hazard ratio, 1.30; 95% CI, 1.20-1.41; P = .0001). CONCLUSIONS: Polyvascular disease is common in patients undergoing CEA and LEB and is associated with a higher risk of perioperative MI/death and decreased long-term survival. After revascularization, patients with polyvascular disease should be considered for more aggressive cardioprotective medications and closer follow-up.

Investigator attitudes on equipoise and practice patterns in the BEST-CLI trial.

OBJECTIVES: There has been significant variability in practice patterns and equipoise regarding treatment approach for chronic limb-threatening ischemia (CLTI). We aimed to assess treatment preferences of Best Endovascular vs Best Surgical Therapy in Patients with CLTI (BEST-CLI) investigators prior to and following the trial. METHODS: An electronic 60-question survey was sent to 1180 BEST-CLI investigators in 2022, after trial conclusion and before announcement of results. Investigators' preferences were assessed across clinical scenarios for both open (OPEN) and endovascular (ENDO) revascularization strategies. Vascular surgeon (VS) surgical and ENDO preferences were compared with a 2010 survey administered to prospective investigators before trial funding. RESULTS: For the 2022 survey, the response rate was 20.2% and was comprised of VSs (76.3%), interventional cardiologists (11.4%) and interventional radiologists (11.6%). The majority (72.6%) were in academic practice and 39.1% were in practice for >20 years. During initial CLTI work-up, 65.8%, 42.6%, and 55.9% of respondents always or usually ordered an arterial duplex, computed tomography angiography, and vein mapping, respectively. The most common practice distribution between ENDO and OPEN procedures was 70/30. Postoperatively, a majority reported performing routine duplex surveillance of vein bypass (99%), prosthetic bypass (81.9%), and ENDO interventions (86%). A minority reported always or usually using the wound, ischemia, and foot infection (WIfI) criteria (25.8%), GLASS (8.3%), and a risk calculator (14.8%). More than one-half (52.9%) agreed that the statement "no bridges are burned with an ENDO-first approach" was false. Intervention choice was influenced by availability of the operating room or ENDO suite, personal schedule, and personal skill set in 30.1%, 18.0%, and 45.9% of respondents, respectively. Most respondents reported routinely using paclitaxel-coated balloons (88.1%) and stents (67.5%); however, 73.3% altered practice when safety concerns were raised. Among surgeons, 17.8%, 2.9%, and 10.3% reported performing >10 annual alternative autogenous vein bypasses, composite vein composite vein bypasses, and bypasses to pedal targets, respectively. Among all interventionalists, 8%, 24%, and 8% reported performing >10 annual radial access procedures, pedal or tibial access procedures, and pedal loop revascularizations. The majority (89.1%) of respondents felt that CLTI teams improved care; however, only 23.2% had a defined team. The effectiveness of the teamwork at institutions was characterized as highly effective in 42.5%. When comparing responses by VSs to the 2010 survey, there were no changes in preferred treatment based on Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC) II classification or conduit preference. In 2022, OPEN surgery was preferred more for a popliteal occlusion. For clinical scenarios, there were no differences except a decreased proportion of respondents who felt there was equipoise for major tissue loss for major tissue loss (43.8% vs 31.2%) and increased ENDO choice for minor tissue loss (17.6% vs 30.8%) (P < .05). CONCLUSIONS: There is a wide range of practice patterns among vascular specialists treating CLTI. The majority of investigators in BEST-CLI had experience in both advanced OPEN and ENDO techniques and represent a real-world sample of technical expertise. Over the course of the decade of the BEST-CLI trial, there was overall similar equipoise among VSs.

"Evolution of Drug-Coated Devices for the Treatment of Chronic Limb Threatening Ischemia".

For patients with Chronic Limb Threatening Ischemia (CLTI), endovascular approaches to revascularization are often employed as a component of multimodality care aimed at limb preservation. However, patients with CLTI are also prone to treatment failure, particularly following balloon angioplasty alone. Drug-coated devices utilizing Paclitaxel were developed to decrease restenosis but have been primarily studied in patients presenting with claudication. In recent years, data have emerged which describe the efficacy of drug-coated devices in the treatment of patients with CLTI. Concurrently, there has been major controversy surrounding the use of drug-coated devices in peripheral arterial disease. A historical narrative of the development and use of drug-coated devices for peripheral arterial disease is presented, along with discussion of major trials. Evidence argues that paclitaxel-based therapies for peripheral arterial disease (PAD) do not increase mortality risk compared to nondrug-coated devices. In CLTI patients, paclitaxel-based balloons and stents provide superior patency and freedom reintervention compared to nondrug-coated devices when treating femoropopliteal disease. However, the use of Paclitaxel-based therapies for below-the-knee (BTK) interventions has not been shown to provide clinically meaningful outcomes compared to nondrug-based therapies. Newer generation antiproliferative agents (Sirolimus, Everolimus) and delivery systems (bioabsorbable scaffolds) hold promise for BTK interventions with early data suggesting decreased rates of major amputation or major adverse limb events.

Evaluation of Computerized Tomography Utilization in Comparison to Digital Subtraction Angiography in Patients with Peripheral Arterial Disease.

BACKGROUND: Perform literature review to analyze current practices in imaging patient with peripheral arterial disease (PAD) and examine patterns in our practice in order to assess whether a lower extremity computed tomography angiography (CTA) in addition to digital subtraction angiography enhanced the assessment of vessel calcification, percentage of stenosis, and affected outcomes in patients with PAD. METHODS: The study included patients who underwent lower extremity imaging and were followed up to 12 months. This population was divided into cases who had both an angiogram and CTA performed within 30 days (n = 20), and controls who underwent angiography only (n = 19). Baseline characteristics, imaging results, and clinical outcomes were analyzed. RESULTS: Thirty-nine patients met study criteria (mean age was 58.4 years, 69.2% were males, and 33.3% had diabetes). Patients mostly presented with tissue loss/rest pain (10.3%), claudication (15.4%), acute limb (10.3%), and trauma (15.4%). We have not observed any statistically significant differences in various examined blood vessels when their features (e.g., vessel diameter, stenosis, calcifications) were assessed by CTA combined with angiography versus angiography alone. The exceptions were external iliac artery, superficial femoral artery and dorsalis pedis vessels. In external iliac artery percentage of stenosis was 1.11% as determined by computed tomography (CT) scan versus 30% by angiography (P = 0.009). For superficial femoral artery stenosis, the percentage determined by CT was 48.68% vs. 81.41% by angiography, and observed difference between 2 modalities was statistically significant (P = 0.025). For dorsalis pedis percentage of stenosis detected by CT scan was 60.63% vs. 22.73% by angiography, and the differences in findings by these modalities were statistically significant (P = 0.039). The most frequent perioperative complication was cardiac-related (35.5%). Nineteen patients were readmitted and 8 had reinterventions within 12 months. CONCLUSIONS: Both imaging modalities yielded similar results for assessing vessel calcification and percentage of stenosis regardless of anatomic vessel location. Overall, utilization of CTA in addition to angiography for large vessels above the knee (e.g., iliac artery, superficial femoral artery) and below the knee for dorsalis pedis provided more detailed information on the properties of these vessels. Therefore, during preoperative assessments, CTA may be helpful in addition to angiography for planning surgical and endovascular interventions for symptomatic PAD treatment in larger vessels.

Cold-induced vasodilation during sequential immersions of the hand.

A common practice for those operating in cold environments includes repetitive glove doffing and donning to perform specific tasks, which creates a repetitive cycle of hand cooling and rewarming. This study aimed to determine the influence of intraday repeated hand cooling on cold-induced vasodilation (CIVD), sympathetic activation, and finger/hand temperature recovery. Eight males and two females (mean ± SD age: 28 ± 5 year; height: 181 ± 9 cm; weight: 79.9 ± 10.4 kg) performed two 30-min hand immersions in cold (4.3 ± 0.92 °C) water in an indoor environment (18 °C). Both immersions (Imm1; Imm2) were performed on the same day and both allowed for a 10-min recovery. CIVD components were calculated for each finger (index, middle, ring) during each immersion. CIVD onset time (index, p = 0.546; middle, p = 0.727; ring, p = 0.873), minimum finger temperature (index, p = 0.634; middle, p = 0.493; ring, p = 0.575), and mean finger temperature (index, p = 0.986; middle, p = 0.953; ring, p = 0.637) were all similar between immersions. Recovery rates generally demonstrated similar responses as well. Findings suggest that two sequential CIVD tests analyzing the effect of prior cold exposure of the hand does not impair the CIVD response or recovery. Such findings appear promising for those venturing into cold environments where hands are likely to be repeatedly exposed to cold temperatures.

An expert panel's review on patients with hereditary angioedema switching from attenuated androgens to oral prophylactic therapy.

Background: Hereditary angioedema (HAE) is a rare condition marked by swelling episodes in various body parts, including the extremities, upper airway, face, intestinal tract, and genitals. Long-term prophylaxis (LTP), prescribed to control recurring HAE attacks, is integral to its management. Previously, attenuated androgens (AAs) were the only oral LTP options. However, in 2020, berotralstat, an oral plasma kallikrein inhibitor, was approved in the United States. A 2018 survey of adults with HAE type I or type II showed that almost all the patients who used prophylactic HAE medication preferred oral treatment (98%) and felt that it fit their lifestyle better than injectable treatment (96%). Still, guidelines lack consensus on transitioning patients from AAs to alternative oral prophylactic therapy. Objective: This paper aims to share expert insights and patient feedback on transitioning from AAs to berotralstat, an alternative oral prophylactic therapy, from the perspective of clinicians with extensive experience in treating patients with HAE. Methods: A panel of five HAE specialists convened for a virtual half-day roundtable discussion in April 2023. Results: Discussions about transitioning from AAs to berotralstat were prompted by routine consultations, patient inquiries based on independent research, ineffective current treatment, or worsening AA-related adverse effects. For patients who switched from AAs, the physicians reported that the decision was influenced by the alternative therapy's ability to prevent HAE attacks, its safety, and the once-daily administration schedule. All expert panel members identified fewer AA-related adverse effects; better quality of life; and less severe, shorter, and less frequent HAE attacks as clinical or patient goals they hoped to achieve through the treatment switch. Conclusion: The emergence of new, highly specific LTP drugs for HAE calls for the development of comprehensive recommendations and guidelines for transitioning from AAs to alternative oral prophylactic therapy. The expert panel highlighted key factors to consider during the development of such guidelines.

Leadership to Accelerate Healthcare's Digital Transformation: Evidence From 33 Health Systems.

GOAL: The COVID-19 pandemic, healthcare market disruptors, and new digital healthcare technologies have made a substantial impact on the delivery of healthcare services, highlighting the critical roles of leaders in hospitals and health systems. This study sought to understand the evolving roles of CEOs, CIOs, and other executive leaders in the postpandemic era and highlight the adaptability and strategic vision of executives in shaping the future of healthcare delivery. METHODS: Between October 2022 and May 2023, 51 interviews were conducted with CEOs, CIOs, and other executives responsible for delivering technology solutions for 33 nonprofit health systems in the United States. They were asked to describe their backgrounds; how information solutions and technologies were viewed within their organizations' strategy, operations, and governance; and the key characteristics of executive leaders. PRINCIPAL FINDINGS: The study has found that effective CEOs have an authentic belief in technology's role in achieving their organization's mission and that contemporary CIOs are strategic executive partners who align strategy with culture to improve care. This study examines how healthcare systems are creating digitally savvy executive leadership teams that operate in a new, integrated model that unites previously siloed functions. PRACTICAL APPLICATIONS: Some healthcare CIOs are unprepared for current and future business challenges, and some CEOs are unsure how to leverage digital technologies and C-suite expertise to transform their organizations. This research provides insights into how the nation's health systems are building and sustaining leadership teams capable of adapting to the healthcare environment and accelerating organizational transformation.

Symptomatic peripheral artery disease increases risk of perioperative mortality following open abdominal aortic aneurysm repair.

OBJECTIVE: Peripheral artery disease (PAD) is associated with worse survival following abdominal aortic aneurysm (AAA) repair. However, little is known about the impact of PAD and sex on outcomes following open infrarenal AAA repair (OAR). METHODS: All elective open infrarenal AAA cases were queried from the Society for Vascular Surgery Vascular Quality Initiative from 2003 to 2022. PAD was defined as history of non-cardiac arterial bypass, non-coronary percutaneous vascular intervention (PVI), or non-traumatic major amputation. Cohorts were stratified by sex and history of PAD. Multivariable logistic regression and Cox proportional hazards models were constructed to assess the primary endpoints: 30-day and 5-year mortality, respectively. RESULTS: Of 4910 patients who underwent elective OAR, 3421 (69.7%) were men without PAD, 298 (6.1%) were men with PAD, 1098 (22.4%) were women without PAD, and 93 (1.9%) were women with PAD. Men with PAD had prior bypass (45%), PVI (62%), and amputation (6.7%). Women with PAD had prior bypass (32%), PVI (76%), and amputation (5.4%). Thirty-day mortality was significantly higher in men with PAD compared with men without PAD (4.4% vs 1.7%; P = .001) and in women with PAD compared with women without PAD (7.5% vs 2.4%; P = .01). After risk adjustment, when compared with men without PAD, women with PAD had nearly four times the odds of 30-day mortality (odds ratio, 3.86; 95% confidence interval [CI], 1.55-9.64; P = .004) and men with PAD had almost three times the odds of 30-day mortality (odds ratio, 2.77; 95% CI, 1.42-5.40; P = .003). Five-year survival was 87.8% in men without PAD, 77.8% in men with PAD, 85% in women without PAD, and 76.2% in women with PAD (P < .001). After risk adjustment, only men with PAD had an increased hazard of death at 5 years (hazard ratio, 1.52; 95% CI, 1.07-2.17; P = .019) compared with men without PAD. CONCLUSIONS: PAD is a potent risk factor for increased perioperative mortality in both men and women following OAR. In women, this equates to nearly four times the odds of perioperative mortality compared with men without PAD. Future study evaluating risk/benefit is needed to determine if women with PAD reflect a high-risk cohort that may benefit from a more conservative OAR threshold for treatment.

Medical center reimbursement for vascular procedures has increased over time while professional reimbursement has declined.

OBJECTIVE: The United States healthcare system uses different methods for assigning medical center reimbursement (MCR) and professional reimbursement (PR) for clinical services. We hypothesized that PR has not increased proportionately to MCR for the same vascular services. METHODS: MCR and PR were compared for commonly performed inpatient and outpatient vascular procedures between 2012 and 2021. MCR was calculated using the Medicare inpatient prospective payment system and outpatient prospective payment system. MCR is based on the Centers for Medicare and Medicaid Services definition and criteria for comorbidities and the occurrence of complications; thus, changes in MCR were reported as a range based on the degree of comorbidities and complications using the Diagnosis Related Group. PR was calculated using the Medicare physician fee schedule, which assigns a numerical work relative value unit to each surgical service, with final compensation determined by an annually adjusted conversion factor to yield a final dollar amount. The expected reimbursement based on the observed inflation during the study period using the consumer price index was calculated and compared to the actual reimbursement. RESULTS: From 2012 to 2021, MCR for inpatient procedures increased 20% to 26% for carotid endarterectomy, 24% to 27% for femoral endarterectomy, 24% to 27% for femoropopliteal bypass with vein, 14% to 19% for thoracic endovascular aortic repair, and 15% for aortobifemoral bypass. During the same period, PR increased 3.3% for carotid endarterectomy but decreased for femoral endarterectomy (-5.0%), femoropopliteal bypass (-4.6%), thoracic endovascular aortic repair (-4.2%), and aortobifemoral bypass (-5.0%). Comparing the expected reimbursement, adjusted for inflation, to the actual reimbursement, PR experienced a 10% to 17% reduction but MCR outpaced inflation by 3.7% to 10%. For outpatient procedures, MCR increased 117% for tibial angioplasty, 24% for superficial femoral artery (SFA) stenting, 62% for tunneled dialysis catheter (TDC) insertion, and 24% for iliac stenting but decreased 0.43% for arteriovenous fistula (AVF) creation and 7.6% for radiofrequency ablation (RFA). PR increased 0.91% for SFA stenting but decreased for tibial angioplasty (-17%), AVF creation (-6.4%), TDC insertion (-7.1%), iliac stenting (-3.8%), and RFA (-22%). Comparing the expected reimbursement, adjusted for inflation, to the actual reimbursement, PR experienced a 13% to 32% reduction. In contrast, MCR outpaced inflation 7.5% to 88% for tibial angioplasty, SFA stenting, TDC insertion, and iliac stenting but experienced a reduction for AVF (-13%) and RFA (-19%). CONCLUSIONS: MCR for commonly performed vascular procedures has increased and outpaced inflation. In contrast, PR for these same services has decreased across all procedure types. This decrease in PR was exacerbated when adjusted for inflation. This inequity in the reimbursement methods between MCR and PR poses a threat to the viability of the physician workforce. Either changes to the reimbursement methods or a reallocation of reimbursement to physicians are imperative to sustain physician practices.

Characterization and management of type II and complex endoleaks after fenestrated/branched endovascular aneurysm repair.

INTRODUCTION: Endoleaks are more common after fenestrated/branched endovascular aneurysm repair (F/B-EVAR) than infrarenal EVAR secondary to the length of aortic coverage and number of component junctions. Although reports have focused on type I and III endoleaks, less is known regarding type II endoleaks after F/B-EVAR. We hypothesized that type II endoleaks would be common and often complex (associated with additional endoleak types), given the potential for multiple inflow and outflow sources. We sought to describe the incidence and complexity of type II endoleaks after F/B-EVAR. METHODS: F/B-EVAR data prospectively collected at a single institution in an investigational device exemption clinical trial (G130210) were retrospectively analyzed (2014-2021). Endoleaks were characterized by type, time to detection, and management. Primary endoleaks were defined as those present on completion imaging or at first postoperative imaging, and secondary were those on subsequent imaging. Recurrent endoleaks were those that developed after a successfully resolved endoleak. Reinterventions were considered for type I or III endoleaks or any endoleak associated with sac growth >5 mm. Technical success defined as the absence of flow in the aneurysm sac at procedure conclusion and methods of intervention were captured. RESULTS: Among 335 consecutive F/B-EVARs (mean ± standard deviation follow-up: 2.5 ± 1.5 years), 125 patients (37%) experienced 166 endoleaks (81 primary, 72 secondary, and 13 recurrent). Of these 125 patients, 50 (40% of patients) underwent 71 interventions for 60 endoleaks. Type II endoleaks were the most frequent (n = 100, 60%), with 20 identified during the index procedure, 12 (60%) of which resolved before 30-day follow-up. Of the 100 type II endoleaks, 20 (20%; 12 primary, 5 secondary, and 3 recurrent) were associated with sac growth; 15 (75%) of those with associated sac growth underwent intervention. At intervention, 6 (40%) were reclassified as complex, with a concomitant type I or type III endoleak. Initial technical success for endoleak treatment was 96% (68 of 71). There were 13 recurrences, all of which were associated with complex endoleaks. CONCLUSIONS: Nearly half of the patients who underwent F/B-EVAR experienced an endoleak. The majority were classified as type II, with nearly a fifth associated with sac expansion. Interventions for a type II endoleak frequently led to reclassification as complex, with a concomitant type I or III endoleak not appreciated on computed tomography angiography and/or duplex. Further study is needed to determine if the primary treatment goal for complex aneurysm repair is sac stability or sac regression, as this would inform both the importance of properly classifying endoleaks noninvasively and the intervention threshold for managing type II endoleaks.

Initial single-center experience using Fiber Optic RealShape guidance in complex endovascular aortic repair.

OBJECTIVE: In the present study, we have described the technical success using Fiber Optic RealShape (FORS) endovascular guidance and its effects on the overall procedural time and radiation usage during complex endovascular aortic repair (EVAR). METHODS: Fenestrated and branched EVARs performed at a single center from 2017 to 2022 were prospectively studied. FORS-guided procedures were matched retrospectively 1:3 to non-FORS-guided procedures by the incorporated target arteries and body mass index. Technical success was defined as successful target vessel cannulation using FORS for the entirety of navigation (wire insertion to exchange for a stiff wire). The predictors of technical success were evaluated via logistic regression. The procedural times and radiation doses were compared between the matched cohorts using the Wilcoxon rank sum test. RESULTS: A total of 21 FORS-guided procedures were matched to 61 non-FORS-guided procedures. A total of 95 FORS cannulations were attempted (87 for the visceral target artery and 8 for the bifurcate gate). Technical success was achieved in 81 cannulations (85%); 15 (16%) were completed without the use of live fluoroscopy. The univariate predictors of FORS technical success included <50% target artery stenosis, <50% target artery calcification, and the target vessel attempted (P < .05 for each). FORS failures were attributed to device material properties in six cases, device failure in two cases, and the wire/catheter combination in six. The use of FORS guidance was associated with shorter median procedural and fluoroscopy times and a lower dose area product and air kerma (P ≤ .0001 for each). CONCLUSIONS: The results from our initial experience with FORS during complex EVAR, including our learning curve, has shown promise, with acceptable technical success and reductions in procedural times and radiation usage.

Successful implementation of a nurse-navigator-run program using natural language processing identifying patients with an abdominal aortic aneurysm.

BACKGROUND: Abdominal aortic aneurysms (AAA) are often identified incidentally on imaging studies. Patients and/or providers are frequently unaware of these AAA and the need for long-term follow-up. We sought to evaluate the outcome of a nurse-navigator-run AAA program that uses a natural language processing (NLP) algorithm applied to the electronic medical record (EMR) to identify patients with imaging report-identified AAA not being followed actively. METHODS: A commercially available AAA-specific NLP system was run on EMR data at a large, academic, tertiary hospital with an 11-year historical look back (January 1, 2010, to June 2, 2021), to identify and characterize AAA. Beginning June 3, 2021, a direct link between the NLP system and the EMR enabled for real-time review of imaging reports for new AAA cases. A nurse-navigator (1.0 full-time equivalent) used software filters to categorize AAA according to predefined metrics, including repair status and adherence to Society for Vascular Surgery imaging surveillance protocol. The nurse-navigator then interfaced with patients and providers to reestablish care for patients not being followed actively. The nurse-navigator characterized patients as case closed (eg, deceased, appropriate follow-up elsewhere, refuses follow-up), cases awaiting review, and cases reviewed and placed in ongoing surveillance using AAA-specific software. The primary outcome measures were yield of surveillance imaging performed or scheduled, new clinic visits, and AAA operations for patients not being followed actively. RESULTS: During the prospective study period (January 1, 2021, to December 30, 2021), 6,340,505 imaging reports were processed by the NLP. After filtering for studies likely to include abdominal aorta, 243,889 imaging reports were evaluated, resulting in the identification of 6495 patients with AAA. Of these, 2937 cases were reviewed and closed, 1183 were reviewed and placed in ongoing surveillance, and 2375 are awaiting review. When stratifying those reviewed and placed in ongoing surveillance by maximum aortic diameter, 258 were 2.5 to 3.4 cm, 163 were 3.5 to 3.9 cm, 213 were 4 to 5 cm, and 49 were larger than 5 cm; 36 were saccular, 86 previously underwent open repair, 274 previously underwent endovascular repair, and 104 were other. This process yielded 29 new patient clinic visits, 40 finalized imaging studies, 29 scheduled imaging studies, and 4 AAA operations in 3 patients among patients not being followed actively. CONCLUSIONS: The application of an AAA program leveraging NLP successfully identifies patients with AAA not receiving appropriate surveillance or counseling and repair. This program offers an opportunity to improve best practice-based care across a large health system.

Thoracic endovascular aortic repair of metachronous thoracic aortic aneurysms following prior infrarenal abdominal aortic aneurysm repair.

OBJECTIVE: Thoracic endovascular aortic repair (TEVAR) of metachronous thoracic aortic aneurysms (M-TAAs) following previous infrarenal abdominal aortic aneurysm (AAA) repair has been associated with higher spinal cord ischemia (SCI) risk compared with TEVAR of primary thoracic aortic aneurysms (TAAs). However, data on the impact of the type of prior infrarenal aortic repair on outcomes are scarce. In this study, we examined perioperative outcomes and long-term mortality following TEVAR M-TAA compared with primary TEVAR of TAA. METHODS: We identified all Vascular Quality Initiative (VQI) patients who underwent TEVAR of TAA in the descending thoracic aorta from 2013 to 2022. Only patients undergoing primary TEVAR or TEVAR following infrarenal open (OAR) or endovascular (EVAR) repair were included. We performed univariate analyses to identify differences in baseline and procedural characteristics, and multivariable analyses for perioperative outcomes and 5-year mortality using logistic and Cox regression, respectively. RESULTS: We included 1493 patients who underwent primary TEVAR (81%) or TEVAR following prior OAR (9.0%) or prior EVAR (9.7%). Compared with primary TEVAR, patients undergoing TEVAR M-TAA were older, more commonly male, white, and had higher rates of hypertension, smoking, and renal dysfunction. Patients with M-TAA were more likely to be asymptomatic and have larger diameters at presentation but were exposed to greater contrast volume and procedural times relative to primary TEVAR patients. Following risk-adjustment, compared with primary TEVAR, TEVAR after prior EVAR was associated with higher perioperative mortality (9.7% vs 3.9%; odds ratio [OR], 5.3; 95% confidence interval [CI], 2.3-12; P < .001) and 5-year mortality (40% vs 24%; hazard ratio [HR], 2.1; 95% CI, 1.4-3.1; P = .001). Specifically, among octogenarians (n = 375; 25%), the perioperative and 5-year mortality differences were even more pronounced (perioperative mortality: 17% vs 8.4%; OR, 6.7; 95% CI, 2.2-21; P = .001; 5-year mortality: 50% vs 27%; HR, 3.0; 95% CI, 1.5-5.7; P = .010). However, in-hospital complications, including SCI (2.6% vs 2.8%; OR, 1.2; 95% CI, 0.33-3.3; P = .77), were not notably different. In contrast, TEVAR after previous OAR was associated with comparable perioperative mortality (4.4% vs 3.9%; OR, 1.2; 95% CI, 0.32-3.8; P = .73), 5-year mortality (28% vs 24%; HR, 1.3; 95% CI, 0.80-2.1; P = .54), and in-hospital complications, including SCI (2.6% vs 0.7%; OR, 0.21; 95% CI, 0.01-1.1; P = .16). CONCLUSIONS: Patients undergoing TEVAR of M-TAAs after prior EVAR, particularly octogenarians, have higher perioperative and 5-year mortality and therefore, represent a high-risk group. Future efforts should strive to discern the underlying factors leading to these poorer outcomes; meanwhile, these findings emphasize the need for careful patient selection and appropriate preoperative counseling in these high-risk individuals.

The impact of completion and follow-up endoleaks on survival, reintervention, and rupture.

OBJECTIVE: Endoleaks may be seen at case completion of endovascular abdominal aortic aneurysm repair (EVAR), and the presence of an endoleak may impact outcomes. However, the clinical implications of various endoleaks seen during follow-up is not well-described. Therefore, we studied the impact of endoleaks at completion and at follow-up on mid-term outcomes. METHODS: We reviewed patients who underwent EVAR from 2003 to 2016 within the Vascular Quality Initiative-Medicare database and identified patients with endoleak at procedure completion and during follow-up, excluding those presenting with rupture. We stratified cohorts by presence of completion and follow-up endoleak subtypes. The primary outcome was 5-year survival, and secondary outcomes included 5-year freedom from reintervention and freedom from rupture. We used Kaplan-Meier estimates and log-rank tests to analyze differences in time-to-event endpoints. RESULTS: Of 21,745 patients with completion endoleak data, 5085 (23%) had an endoleak. Compared with those without endoleak, those with type I endoleaks had lower 5-year survival (69% vs 75%; P < .001), type II endoleaks had higher survival (79%; P < .001), and types III, IV, and indeterminate were not statistically different (73%, 73%, and 75%, respectively). Freedom from reintervention for types I and III endoleaks were significantly lower than no endoleak cohort (I: 76%; P < .001; III: 72%; P < .001 vs 83%), but freedom from rupture was higher for those with type II and III endoleak (95% and 97% vs 94%; P < .001). Of 14,479 patients with detailed follow-up endoleak data, 2290 (16%) had an endoleak. Compared with those without endoleak, types I and III had significantly lower 5-year survival (I: 80%; P = .002; III: 66%; P < .001 vs 84%), but there were no differences for types II (82%) and indeterminate (77%). Those with any type of follow-up endoleak had lower 5-year freedom from reintervention (I: 70%; P < .001; II: 76%; P = .006; III: 36%; P < .001; indeterminate: 60%; P = .007 vs 84%), and lower freedom from rupture (I: 92%; P < .001; II: 91%; P = .16; III: 88%; P = .01; indeterminate: 90%; P = .11 vs 94%). CONCLUSIONS: Compared with patients with no endoleak, those with type I completion endoleaks have lower 5-year survival and freedom from reintervention. Patients with types I and III follow-up endoleaks also have lower survival, and any endoleak at follow-up is associated with lower freedom from reintervention and freedom from rupture. These data highlight the importance of careful patient selection and close postoperative follow-up after EVAR, as the presence of endoleaks, specifically type I and III, over time portends worse outcomes.

The association between diabetes mellitus and its management with outcomes following endovascular repair for descending thoracic aortic aneurysm.

OBJECTIVE: Prior literature is conflicted regarding the effect of diabetes mellitus (DM) on outcomes after endovascular repair of aortic aneurysms. In this study, we aimed to examine the association between DM and outcomes after thoracic endovascular aneurysm repair (TEVAR) for thoracic aortic aneurysm (TAA). METHODS: We identified patients who underwent TEVAR for TAA of the descending thoracic aorta in the Vascular Quality Initiative between 2014 and 2022. We created two cohorts, DM and nonDM, based on the patient's preoperative DM status, and secondarily substratified patients with DM by management strategy: dietary management, noninsulin medications, and insulin therapy cohorts. Outcomes included perioperative and 5-year mortality, in-hospital complications, indications for repair, and 1-year sac dynamics, which were analyzed with multivariable cox regression, multivariable logistic regression, and χ2 tests, respectively. RESULTS: We identified 2637 patients, of which 473 (18%) had DM preoperatively. Among patients with DM, 25% were diet controlled, 54% noninsulin medications, and 21% insulin therapy. Within patients who underwent TEVAR for TAA, the proportions of ruptured presentation were higher in the dietary-managed (11.1%) and insulin-managed (14.3%) cohorts relative to noninsulin therapy (6.6%) and those without DM (6.9%). After multivariable regression analysis, we found that DM was associated with similar perioperative mortality (odds ratio, 1.14; 95% confidence interval [CI], 0.70-1.81) and 5-year mortality compared with patients without DM (hazard ratio, 1.15; 95% CI, 0.91-1.48). Furthermore, all in-hospital complications were comparable between patients with DM and patients without DM. Compared with patients without DM, dietary management of DM was significantly associated with higher adjusted perioperative mortality (OR, 2.16; 95% CI, 1.03-4.19) and higher 5-year mortality (hazad ratio, 1.50; 95% CI, 1.03-2.20), although this was not the case for other DM subgroups. All cohorts displayed similar 1-year sac dynamics, with sac regression occurring in 47% of patients without DM vs 46% of patients with DM (P = .27). CONCLUSIONS: Preoperatively, patients with DM who underwent TEVAR had a higher proportion of ruptured presentation when treated with diet or insulin medications than when treated with noninsulin medications. After TEVAR for descending TAA, DM was associated with a similar risk of perioperative and 5-year mortality as nonDM. In contrast, dietary therapy for DM was associated with significantly higher perioperative mortality and 5-year mortality.

Are frog calls relatively difficult to locate by mammalian predators?

Frogs call in acoustically dense choruses to attract conspecific females. Their calls can potentially reveal their location to predators, many of which are mammals. However, frogs and mammals have very different acoustic receivers and mechanisms for determining sound source direction. We argue that frog calls may have been selected so that they are harder to locate with the direction-finding mechanisms of mammals. We focus on interaural time delay (ITD) estimation using delay-line coincidence detection (place code), and a binaural excitatory/inhibitory (E/I) ITD mechanism found in mammals with small heads (population code). We identify four "strategies" which frogs may employ to exploit the weaknesses of either mechanism. The first two strategies used by the frog confound delay estimation to increase direction ambiguity using highly periodic calls or narrowband calls. The third strategy relies on using short pulses. The E/I mechanism is susceptible to noise with sounds being pulled to the medial plane when signal-to-noise ratio is low. Together, these three strategies compromise both ongoing and onset determination of location using either mechanism. Finally, frogs call in dense choruses using various means for controlling synchrony, maintaining chorus tenure, and abruptly switching off calling, all of which serve to confound location finding. Of these strategies, only chorusing adversely impacts the localization performance of frogs' acoustic receivers. We illustrate these strategies with an analysis of calls from three different frog species.

Maternal nicotine exposure induces congenital heart defects in the offspring of mice.

Maternal cigarette smoking is a risk factor for congenital heart defects (CHDs). Nicotine replacement therapies are often offered to pregnant women following failed attempts of smoking cessation. However, the impact of nicotine on embryonic heart development is not well understood. In the present study, the effects of maternal nicotine exposure (MNE) during pregnancy on foetal heart morphogenesis were studied. Adult female mice were treated with nicotine using subcutaneous osmotic pumps at 0.75 or 1.5 mg/kg/day and subsequently bred with male mice. Our results show that MNE dose-dependently increased CHDs in foetal mice. CHDs included atrial and ventricular septal defects, double outlet right ventricle, unguarded tricuspid orifice, hypoplastic left ventricle, thickened aortic and pulmonary valves, and ventricular hypertrophy. MNE also significantly reduced coronary artery size and vessel abundance in foetal hearts. Moreover, MNE resulted in higher levels of oxidative stress and altered the expression of key cardiogenic regulators in the developing heart. Nicotine exposure reduced epicardial-to-mesenchymal transition in foetal hearts. In conclusion, MNE induces CHDs and coronary artery malformation in mice. These findings provide insight into the adverse outcomes of foetuses by MNE during pregnancy.

Novel surgical quality metrics in abdominal aortic aneurysm repair.

OBJECTIVE: Existing surgical quality metrics have limited utility, are primarily used for high-mortality procedures, and often fail to account for differences in non-fatal outcomes. Our objective was to develop more comprehensive, novel surgical quality metrics, for patients undergoing abdominal aortic aneurysm (AAA) repair. METHODS: Non-ruptured open and endovascular AAA repair (EVAR) from the Vascular Quality Initiative database were studied, 2016-2019. A win was defined as AAA repair without major complication (in-hospital) or mortality (in-hospital or within 30 days). Centers were divided into quality quartiles based on performance in two novel win-based metrics: (1) Wins Above Average (WAA) and (2) weighted Wins Above Average (wWAA). Patient-level and center-level analyses compared demographics and outcomes between "best" and "worst" quartiles, including wins, mortality, and failure to rescue (FTR) rates. Additional patient-level analyses were performed based on center stratification into volume quartiles. Correlation in surgical quality for open repair and EVAR was determined at centers performing both procedures. RESULTS: Overall, 3683 patients underwent open repair and 21,165 patients underwent EVAR. For open repair, crude rates of win, mortality, and FTR were 62.8%, 4.2%, and 10.3%, respectively. For EVAR, crude rates for win, mortality, and FTR were 94.4%, 1.1%, and 12.3%, respectively. When stratified by wWAA, patients undergoing open repair at "best" quartile centers had a higher win rate (72.0% vs 52.7%; risk ratio [RR], 1.37; 95% confidence interval [CI], 1.28-1.46) and lower mortality (3.1% vs 6.2%; RR, 0.50; 95% CI, 0.33-0.74) compared with "worst" quartile centers. Similarly, for EVAR, "best" quartile centers had a higher win rate (96.2% vs 92.1%; RR, 1.04; 95% CI, 1.03-1.05), lower mortality (0.4% vs 2.2%; RR, 0.19; 95% CI, 0.13-0.29), and a lower FTR rate (5.7% vs 17.9%; RR, 0.32; 95% CI, 0.18-0.56) compared with "worst" quartile centers. Stratification by volume showed that high-volume centers demonstrated improved wWAA for open repair (P = .04) but not for EVAR (P = .3) compared with low-volume centers. For centers that performed both open repair and EVAR, there was no correlation in quality as determined by wWAA (r = -0.056; P = .6). CONCLUSIONS: wWAA is a novel, risk-adjusted, complication-weighted surgical quality metric that also accounts for volume differences. wWAA successfully distinguishes high- and low-quality centers for both open AAA repair and EVAR. This methodology is potentially broadly applicable for measuring surgical quality.