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One in seven adults in the United States has chronic kidney disease (CKD) and individuals with the most severe form, end stage kidney disease (ESKD), may require renal replacement therapy with hemodialysis. Despite well-established guidelines indicating that arteriovenous access is the preferred type of vascular access for hemodialysis, in 2021, 85.4% of patients initiated dialysis with a CVC. While the reasons for this evidence-practice gap are unclear, health literacy and patient disease-specific knowledge may play an important role. Importantly, 25% of patients with CKD have limited health literacy. While there is an abundance of research regarding the presence of poor health literacy, poor kidney disease-specific knowledge, and their association with health outcomes in patients with CKD, there is currently a paucity of data about the relationship between health literacy, vascular access-specific knowledge, and vascular access outcomes. The aim of this narrative review is to describe the relationship between health literacy, disease-specific knowledge, and vascular access in patients with CKD. A better understanding of health literacy in this population will help inform the development of strategies to assess patient vascular access-specific knowledge and aid in vascular access decision making.
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BACKGROUND: Veterans represent a distinct cultural group whose perceptions of illness and treatment are influenced by military culture. The study explores how prior military service shapes Veterans' assumptions and behaviors in the setting of aneurysm repair surgery. STUDY DESIGN: We conducted content and thematic analysis of a case series of 10 transcripts from telephone interviews with older (76.7 ± 4.3 years) African American and White male Veterans now residing in the Southern U.S. who underwent open or endovascular aneurysm surgery at Veterans Affairs Medical Centers or university affiliates between 2004 and2019. RESULTS: Throughout the continuum of care, Veterans described deferring to authority and not questioning provider's decisions ["I just can't make a judgment on that, because I'm not a doctor"]. Veterans valued commitment and articulated pride in keeping logistically challenging surveillance appointments [I always took them very seriously. . . If I'm scheduled for something by the doctor, I always make it."]. The routine structure of VA care aligned with Veterans military experiences, facilitating compliance with doctor's orders. However, procedural deviations in VA care were disconcerting for patients ["They haven't reached out to me in at least three years, since my surgery; I was being seen once a year and then all of a sudden, they just quit."]. While Veterans praised VA care, they exhibited sensitivity to signs of untoward treatment from clinical and support staff " my surgeon, he never talked to me before, nor after, no anytime I thought that maybe that wasn't right". CONCLUSIONS: Military culture embodies rank, order, and respect, and remains a source of strength and stability for Veterans in their medical care late in life. Cultural competency about how military service has shaped Veterans' expectations can enhance providers' awareness of patients' military mindsets and inform surgeons' efforts to engage Veterans in shared decision making.
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Background: Implicit bias can influence behavior and decision-making. In clinical settings, implicit bias may influence treatment decisions and contribute to health disparities. Given documented Black-White disparities in vascular care, the purpose of this study was to examine the prevalence and degree of unconscious bias and awareness of bias among vascular surgeons treating peripheral artery disease (PAD). Methods: The sampling frame included all vascular surgeons who participate in the Vascular Quality Initiative (VQI). Participants completed a survey which included demographic questions, the race implicit association test (IAT) to measure magnitude of unconscious bias, and six bias awareness questions to measure conscious bias. The magnitude of unconscious bias was no preference; or slight, moderate, or strong in the direction of pro-White or pro-Black. Data from participants were weighted to account for nonresponse bias and known differences in the characteristics of surgeons who chose to participate compared to the full registry. We stratified unconscious and conscious findings by physician race/ethnicity, physician sex, and years of experience. Finally, we examined the relationship between unconscious and conscious bias. Results: There were 2,512 surgeons in the VQI registry, 304 of whom completed the survey, including getting IAT results. Most participants (71.6%) showed a pro-White bias with 73.0% of this group in the moderate and strong categories. While 77.5% of respondents showed conscious awareness of bias, of those whose conscious results showed lack of awareness, 67.8% had moderate or strong bias, compared to 55.7% for those with awareness. Bias magnitude varied based on physician race/ethnicity and years of experience. Women were more likely than men to report awareness of biases and potential impact of bias on decision-making. Conclusions: Most people have some level of unconscious bias, developed from early life reinforcements, social stereotypes, and learned experiences. Regarding health disparities, however, these are important findings in a profession that takes care of patients with PAD due to heavy burden of comorbid conditions and high proportion of individuals from structurally vulnerable groups. Given the lack of association between unconscious and conscious awareness of biases, awareness may be an important first step in mitigation to minimize racial disparities in healthcare.
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BACKGROUND: Studies suggest that ambulation after major lower extremity amputation (LEA) is low and mortality after LEA is high. Successful prosthetic fitting after LEA has a significant quality of life benefit; however, it is unclear if there are benefits in post-LEA mortality. Our objective was to examine a contemporary cohort of patients who underwent LEA and determine if there is an association between fitting for a prosthetic and mortality. METHODS: We reviewed all patients who underwent LEA between 2015 and 2022 at two academic health care systems in a large metropolitan city. The exposure of interest was prosthetic fitting after LEA. The primary outcomes were mortality within 1 and 3 years of follow-up. Ambulation after LEA was defined as being ambulatory with or without an assistive device. Patients with prior LEA were excluded. Extended Cox models with time-dependent exposure were used to evaluate the association between prosthetic fitting and mortality at 1 and 3 years of follow-up. RESULTS: Among 702 patients who underwent LEA, the mean (SD) age was 64.3 (12.6) years and 329 (46.6%) were fitted for prosthetic. The study population was mostly male (n = 488, 69.5%), predominantly non-Hispanic Black (n = 410, 58.4%), and nearly one-fifth were non-ambulatory before LEA (n = 139 [19.8%]). Of note, 14.3% of all subjects who were nonambulatory at some point after LEA, and 28.5% of patients not ambulatory preoperatively were eventually ambulatory after LEA. The rate of death among those fitted for a prosthetic was 12.0/100 person-years at 1 year and 5.8/100 person-years at 3 years of follow-up; among those not fitted for a prosthetic, the rate of death was 55.7/100 person-years and 50.7/100 person-years at 1 and 3 years of follow-up, respectively. After adjusting for several sociodemographic data points, comorbidities, pre- or post- coronavirus disease 2019 pandemic timeframe, and procedural factors, prosthetic fitting is associated with decreased likelihood of mortality within 1 year of follow-up (adjusted hazard ratio, 0.24; 95% confidence interval, 0.14-0.40) as well as within 3 years (adjusted hazard ratio, 0.40; 95% confidence interval, 0.29-0.55). CONCLUSIONS: Prosthetic fitting is associated with improved survival, and preoperative functional status does not always predict postoperative functional status. Characterizing patient, surgical, and rehabilitation factors associated with receipt of prosthetic after LEA may improve long-term survival in these patients. Process measures employed by the Department of Veterans Affairs, such as prosthetic department evaluation of all amputees, may represent a best practice.
Subject(s)
Amputation, Surgical , Artificial Limbs , Prosthesis Fitting , Humans , Male , Female , Middle Aged , Amputation, Surgical/mortality , Aged , Retrospective Studies , Risk Factors , Lower Extremity/blood supply , Lower Extremity/surgery , Time Factors , Amputees/rehabilitation , COVID-19/mortality , Risk Assessment , Treatment OutcomeABSTRACT
OBJECTIVE: Peripheral artery disease (PAD) represents a high-volume, high-cost burden on the health care system. The Centers for Medicare and Medicaid Services has developed the Bundled Payments for Care Improvement-Advanced program, in which a single payment is provided for all services administered in a postsurgical 90-day episode of care. Factors associated with 30- and 90-day reinterventions after PAD interventions would represent useful data for both payors and stake holders. METHODS: We conducted a national cohort study of adults 65 years and older in the Vascular Quality Initiative and Centers for Medicare and Medicaid Services-linked dataset who underwent an open, endovascular, or hybrid revascularization procedure for PAD between January 1, 2010, and December 31, 2018. Procedures for acute limb ischemia and aneurysms were excluded. The primary outcome was 90-day reintervention. Reintervention at 30 days was a secondary outcome. Covariates of interest included demographics, comorbidities, and patient- and facility-level characteristics. Multivariable Cox regression was used to determine the association between patient- and facility-level characteristics and the risk of 30- and 90-day reinterventions. RESULTS: Among 42,429 patients (71.3% endovascular, 23.3% open, and 5.4% hybrid), median age was 74 years (interquartile range, 69-80 years), 57.9% were male, and 84.3% were White. Chronic limb-threatening ischemia was the operative indication in 40.4% of the procedures. Overall, 42.8% were completed in the outpatient setting (40.3% outpatient, 2.5% office-based lab). Over 70% of procedures for chronic limb-threatening ischemia were completed as inpatient, whereas 60% of the claudication interventions were done as outpatient. The 90-day reintervention rate was 14.5%, and the 30-day reintervention rate was 5.5%. Compared with inpatient procedures, PAD interventions completed in the outpatient or office-based lab setting had significantly higher 90- and 30-day reintervention rates (reference, inpatient; outpatient 90-day reintervention: hazard ratio [HR], 1.41; 95% confidence interval [CI] 1.25-1.60; outpatient 30-day reintervention: HR, 1.90; 95% CI, 1.62-2.24; office-based lab 90-day reintervention: HR, 2.09; 95% CI, 1.82-2.41; office-based lab 30-day reintervention: HR, 3.54; 95% CI, 3.17-3.94). Open and hybrid approaches demonstrated lower risk of reintervention compared with endovascular procedures at 30 and 90 days and, compared with aortoiliac disease, all other anatomic segments of disease were associated with higher 90-day reintervention, but no difference was noted at 30 days. CONCLUSIONS: Although outpatient PAD interventions may be convenient for patients and providers, the outpatient setting is associated with a significant risk of subsequent reintervention. Additional work is needed to understand how to improve the longevity of outpatient PAD interventions.
Subject(s)
Databases, Factual , Endovascular Procedures , Lower Extremity , Peripheral Arterial Disease , Reoperation , Humans , Aged , Male , Female , Peripheral Arterial Disease/surgery , Peripheral Arterial Disease/therapy , Time Factors , Risk Factors , United States , Aged, 80 and over , Retrospective Studies , Lower Extremity/blood supply , Treatment Outcome , Risk Assessment , Endovascular Procedures/adverse effects , Vascular Surgical Procedures/adverse effects , Postoperative Complications/etiology , Postoperative Complications/therapy , RetreatmentABSTRACT
Disparities by sex, race, socioeconomic status, and geography exist in diagnosis, treatment, and outcomes for people with lower extremity peripheral artery disease (PAD). PAD prevalence is similar in men and women, but women have more atypical symptoms and undergo lower extremity revascularization at older ages compared to men. People who are Black have an approximately 2-fold higher prevalence of PAD, compared to people who are White and have more atypical symptoms, greater mobility loss, less optimal medical care, and higher amputation rates. Although fewer data are available for other races, people with PAD who are Hispanic have higher amputation rates than White people. Rates of amputation also vary by geography in the United States, with the highest rates of amputation in the southeastern United States. To improve PAD outcomes, intentional actions to eliminate disparities are necessary, including clinician education, patient education with culturally appropriate messaging, improved access to high-quality health care, science focused on disparity elimination, and health policy changes.
Subject(s)
Black or African American , Peripheral Arterial Disease , Female , Humans , Male , Healthcare Disparities , Lower Extremity/blood supply , Peripheral Arterial Disease/diagnosis , Peripheral Arterial Disease/epidemiology , Peripheral Arterial Disease/therapy , Risk Factors , Treatment Outcome , United States/epidemiology , White , Hispanic or LatinoABSTRACT
Lower-extremity peripheral artery disease (PAD), the accumulation of atherosclerotic plaque in the arteries of the legs, causes substantial morbidity and mortality. Frequent under- and delayed diagnosis result in poor outcomes, disproportionately affecting individuals from racial and ethnic minority groups. To understand barriers to early detection and treatment and factors contributing to disparities, American Medical Group Association (AMGA) conducted roundtable discussions and semistructured interviews in 2021. Eighteen participants discussed PAD evaluation, diagnosis, early medical management, and disparities in care. A qualitative case study approach and data reduction methods were used to generate themes, draw conclusions, and make actionable recommendations. Identified themes included lack of (1) prioritization of PAD for population health; (2) engagement of primary care providers in early evaluation and referral; (3) "ownership" of lower-extremity PAD within health systems; and (4) focus on disparities in care. Participant solutions included (1) financial impact of early PAD management, in the context of value-based payment; (2) embedding an advanced practice provider into a vascular surgery practice to facilitate evaluation and provide medical therapy; and (3) leveraging care coordination, multidisciplinary clinics, and telehealth technology to provide comprehensive care for patients with PAD and address disparities. A deliberate focused effort is necessary to close gaps and the accompanying disparities in early evaluation, diagnosis, and treatment for people with lower-extremity PAD. The authors describe 3 models that can be emulated to improve care for this high-risk population. With improved reimbursement and better medical therapies, now is the time to focus on early diagnosis and management of PAD.
Subject(s)
Ethnicity , Peripheral Arterial Disease , Humans , Minority Groups , Peripheral Arterial Disease/diagnosis , Peripheral Arterial Disease/therapy , Peripheral Arterial Disease/epidemiology , Lower Extremity/blood supply , Early DiagnosisABSTRACT
OBJECTIVE: Lower extremity revascularization (LER) for peripheral artery disease is complicated by the frequent need for readmission. However, it is unclear if readmission to a nonindex LER facility (ie, a facility different from the one where the LER was performed) compared with the index LER facility is associated with worse outcomes. METHODS: This was a national cohort study of older adults who underwent open, endovascular, or hybrid LER for peripheral artery disease (January 1, 2010, to December 31, 2018) in the Vascular Quality Initiative who were readmitted within 90 days of their vascular procedure. This dataset was linked to Medicare claims and the American Hospital Association Annual Survey. The primary outcome was 90-day mortality and the secondary outcome was major amputation at 90 days after LER. The primary exposure was the location of the first readmission after LER (categorized as occurring at the index LER facility vs a nonindex LER facility). Generalized estimating equations logistic regression models were used to assess the association between readmission location and 90-day mortality and amputation. RESULTS: Among 42,429 patients who underwent LER, 33.0% were readmitted within 90 days. Of those who were readmitted, 27.3% were readmitted to a nonindex LER facility, and 42.2% of all readmissions were associated with procedure-related complications. Compared with patients readmitted to the index LER facility, those readmitted to a nonindex facility had a lower proportion of procedure-related reasons for readmission (21.5% vs 50.1%; P < .001). Most of the patients readmitted to a nonindex LER facility lived further than 31 miles from the index LER facility (39.2% vs 19.6%; P < .001) and were readmitted to a facility with a total bed size of <250 (60.1% vs 11.9%; P < .001). Readmission to a nonindex LER facility was not associated with 90-day mortality or 90-day amputation. However, readmission for a procedure-related complication was associated with major amputation (90-day amputation: adjusted odds ratio, 3.33; 95% confidence interval, 2.89-3.82). CONCLUSIONS: Readmission after LER for a procedure-related complication is associated with subsequent amputation. This finding suggests that quality improvement efforts should focus on understanding various types of procedure-related failure after LER and its role in limb salvage.
Subject(s)
Patient Readmission , Peripheral Arterial Disease , United States , Humans , Aged , Cohort Studies , Medicare , Peripheral Arterial Disease/diagnosis , Peripheral Arterial Disease/surgery , Limb SalvageABSTRACT
Purpose: It is unclear whether disparities in the care provided before lower extremity amputation (LEA) is driven by differences in receipt of diagnostic work-up versus revascularization attempts. Methods: We performed a national cohort study of Veterans who underwent LEA between March 2010 and February 2020 to assess receipt of vascular assessment with arterial imaging and/or revascularization in the year prior to LEA. Results: Among 19,396 veterans (mean age 66.8 years; 26.6% Black), Black veterans had diagnostic procedures more often than White veterans (47.5% vs. 44.5%) and revascularization as often (25.8% vs. 24.5%). Conclusion: We must identify patient and facility-level factors associated with LEA as disparities do not appear related to differences in attempted revascularization.
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Importance: Patient-level characteristics alone do not account for variation in care among US veterans with peripheral artery disease (PAD). Presently, the extent to which health care utilization and regional practice variation are associated with veterans receiving vascular assessment prior to major lower extremity amputation (LEA) is unknown. Objective: To assess whether demographics, comorbidities, distance to primary care, the number of ambulatory clinic visits (primary and medical specialty care), and geographic region are associated with receipt of vascular assessment prior to LEA. Design, Setting, and Participants: This national cohort study used US Department of Veterans Affairs' Corporate Data Warehouse data from March 1, 2010, to February 28, 2020, for veterans aged 18 or older who underwent major LEA and who received care at Veterans Affairs facilities. Exposures: The number of ambulatory clinic visits (primary and medical specialty care) in the year prior to LEA, geographic region of residence, and distance to primary care. Main Outcomes and Measures: The main outcome was receipt of a vascular assessment (vascular imaging study or revascularization procedure) in the year prior to LEA. Results: Among 19â¯396 veterans, the mean (SD) age was 66.78 (10.20) years and 98.5% were male. In the year prior to LEA, 8.0% had no primary care visits and 30.1% did not have a vascular assessment. Compared with veterans with 4 to 11 primary care clinic visits, those with fewer visits were less likely to receive vascular assessment in the year prior to LEA (1-3 visits: adjusted odds ratio [aOR], 0.90; 95% CI, 0.82-0.99). Compared with veterans who lived less than 13 miles from the closest primary care facility, those who lived 13 miles or more from the facility were less likely to receive vascular assessment (aOR, 0.88; 95% CI, 0.80-0.95). Veterans who resided in the Midwest were most likely to undergo vascular assessment in the year prior to LEA than were those living in other regions. Conclusions and Relevance: In this cohort study, health care utilization, distance to primary care, and geographic region were associated with intensity of PAD treatment before LEA, suggesting that some veterans may be at greater risk of suboptimal PAD care practices. Development of clinical programs, such as remote patient monitoring and management, may represent potential opportunities to improve limb preservation rates and the overall quality of vascular care for veterans.
Subject(s)
Peripheral Arterial Disease , Veterans , Humans , Male , Female , Chronic Limb-Threatening Ischemia , Cohort Studies , Trust , Patient Acceptance of Health Care , Peripheral Arterial Disease/surgery , Health Services Accessibility , Lower Extremity/surgery , Lower Extremity/blood supply , Amputation, SurgicalABSTRACT
The COVID-19 pandemic has profoundly affected health care delivery. In addition to the significant morbidity and mortality associated with acute illness from COVID-19, the indirect impact has been far-reaching, including substantial disruptions in chronic disease care. As a result of pandemic disruptions in health care, vulnerable and minority populations have faced health inequalities. The aim of this review was to investigate how the COVID-19 pandemic has impacted vulnerable populations with limb-threatening peripheral artery disease and diabetic foot infections.
Subject(s)
COVID-19 , Diabetes Mellitus , Diabetic Foot , Peripheral Arterial Disease , Humans , COVID-19/epidemiology , COVID-19/complications , Pandemics , Diabetic Foot/diagnosis , Diabetic Foot/epidemiology , Diabetic Foot/surgery , Peripheral Arterial Disease/diagnosis , Peripheral Arterial Disease/epidemiology , Peripheral Arterial Disease/surgery , Amputation, SurgicalABSTRACT
BACKGROUND: Upper extremity hemodialysis arteriovenous fistulas (AVFs) can become aneurysmal over time due to repeated cannulation and/or outflow steno-occlusive disease. The optimal surgical management of aneurysmal AVFs (aneurysmorrhaphy vs interposition graft) has remained unclear. METHODS: We performed a retrospective review in which current procedural terminology codes were used to screen for patients who had undergone surgical treatment of aneurysmal AVFs between 2016 and 2021 at a single hospital system. The patients were included after a review of the operative reports. The cases were divided by surgical procedure (aneurysmorrhaphy vs interposition graft placement). The patients who had undergone primary AVF ligation or other types of repair were excluded. The primary outcomes were primary assisted and secondary patency, and the secondary outcome was dialysis access abandonment. Multivariable Cox proportional hazards regression was used to test the association between the type of AVF aneurysm repair and the primary and secondary outcomes. RESULTS: From 2016 to 2021, 6951 patients had undergone 16,190 dialysis access procedures. Of these procedures, 381 (2.4%) were related to surgical treatment of an aneurysmal AVF. We excluded 58 primary AVF ligation cases and 20 cases involving other types of repair, leaving 303 cases for analysis. These were divided into two groups: aneurysmorrhaphy (n = 123; 41%) and interposition graft (n = 180; 59%). No differences were found between the groups in male gender (68% vs 63%), hypertension (98% vs 98%), or central stenosis (14% vs 22%). The patients who had undergone aneurysmorrhaphy were younger (median age, 54 years vs 59 years); had had a lower rate of diabetes (41% vs 59%), coronary artery disease (41% vs 58%), and congestive heart failure (41% vs 55%); and were less likely to have undergone upper arm access (72% vs 92%). The median follow-up was 11.1 months (interquartile range, 3.6-25.2 months). No differences were found in the incidence of 30-day wound complications (1% vs 3%) or surgical site infections (4% vs 6%). On multivariable Cox regression, interposition graft placement was associated with the loss of primary assisted patency (adjusted hazard ratio [aHR], 2.42; 95% confidence interval [CI], 1.18-4.95), loss of secondary patency (aHR, 3.10; 95% CI, 1.21-7.94), and abandonment of dialysis access (aHR, 3.07; 95% CI, 1.61-5.87; P < .05 for all) at 2 years. CONCLUSIONS: AVF aneurysmorrhaphy was associated with improved primary assisted and secondary patency and decreased abandonment of dialysis access. We suggest using aneurysmorrhaphy when AVF aneurysms are indicated for repair. However, individual factors such as patient comorbidities, AVF anatomy, remaining dialysis access options, and patient preference should be considered when planning the surgical approach.
Subject(s)
Arteriovenous Fistula , Arteriovenous Shunt, Surgical , Humans , Male , Middle Aged , Arteriovenous Shunt, Surgical/adverse effects , Graft Occlusion, Vascular/etiology , Vascular Patency , Treatment Outcome , Risk Factors , Renal Dialysis/adverse effects , Retrospective Studies , Arteriovenous Fistula/complicationsABSTRACT
BACKGROUND: Upper extremity (UE) vascular injuries account for 18.4% of all traumatic vascular injuries. Arterial pressure index (API) use in lower extremity injuries to determine the need for further investigations is well established. However, due to collateral circulation in UEs, it is unclear if the same algorithm can be applied. The purpose of this study was to determine if APIs can be used to determine the need for computed tomography angiogram (CTA) in penetrating UE trauma. METHODS: All adult trauma patients with penetrating UE trauma and APIs from 2006 to 2016 were identified at 3 urban US level 1 trauma centers. Sensitivity, specificity, and positive and negative predictive values of APIs <.9 in detecting UE arterial injuries were calculated. RESULTS: During the 11-year study period, 218 patients met our inclusion criteria. Gunshot wounds comprised 76.6% and stab wounds 17.9%. Median injury severity score and API were 9 and 1, respectively. Seventy-two of our patients underwent evaluation with CTA. Of the injuries, the most common were thrombus or occlusion (46.7%), transection (23.1%), and dissection (15.4%), radiographically. Ultimately, 32 patients underwent surgical.
Subject(s)
Arm Injuries , Vascular System Injuries , Wounds, Gunshot , Wounds, Penetrating , Adult , Humans , Vascular System Injuries/diagnostic imaging , Vascular System Injuries/surgery , Arterial Pressure , Retrospective Studies , Wounds, Penetrating/diagnostic imaging , Wounds, Penetrating/surgery , Upper Extremity/diagnostic imaging , Upper Extremity/blood supply , Extremities/diagnostic imagingABSTRACT
Telehealth enables the remote delivery of health care through telecommunication technologies and has substantially affected the evolving medical landscape. The COVID-19 pandemic accelerated the utilization of telehealth as health care professionals were forced to limit face-to-face in-person visits. It has been shown that information delivery, diagnosis, disease monitoring, and follow-up care can be conducted remotely, resulting in considerable changes specific to cardiovascular disease management. Despite increasing telehealth utilization, several factors such as technological infrastructure, reimbursement, and limited patient digital literacy can hinder the adoption of remote care. This scientific statement reviews definitions pertinent to telehealth discussions, summarizes the effect of telehealth utilization on cardiovascular and peripheral vascular disease care, and identifies obstacles to the adoption of telehealth that need to be addressed to improve health care accessibility and equity.
Subject(s)
COVID-19 , Cardiovascular Diseases , Telemedicine , United States , Humans , American Heart Association , Pandemics , Telemedicine/methodsABSTRACT
OBJECTIVE: To evaluate long term outcomes (reintervention and late rupture of abdominal aortic aneurysm) of aortic endografts in real world practice using linked registry claims data. DESIGN: Observational surveillance study. SETTING: 282 centers in the Vascular Quality Initiative Registry linked to United States Medicare claims (2003-18). PARTICIPANTS: 20 489 patients treated with four device types used for endovascular abdominal aortic aneurysm repair (EVAR): 40.6% (n=8310) received the Excluder (Gore), 32.2% (n=6606) the Endurant (Medtronic), 16.0% (n=3281) the Zenith (Cook Medical), and 11.2% (n=2292) the AFX (Endologix). Given modifications to AFX in late 2014, patients who received the AFX device were categorized into two groups: the early AFX group (n=942) and late AFX group (n=1350) and compared with patients who received the other devices, using propensity matched Cox models. MAIN OUTCOME MEASURES: Reintervention and rupture of abdominal aortic aneurysm post-EVAR; all patients (100%) had complete follow-up via the registry or claims based outcome assessment, or both. RESULTS: Median age was 76 years (interquartile range (IQR) 70-82 years), 80.0% (16 386/20 489) of patients were men, and median follow-up was 2.3 years (IQR 0.9-4.1 years). Crude five year reintervention rates were significantly higher for patients who received the early AFX device compared with the other devices: 14.9% (95% confidence interval 13.7% to 16.2%) for Excluder, 19.5% (18.1% to 21.1%) for Endurant, 16.7% (15.0% to 18.6%) for Zenith, and early 27.0% (23.7% to 30.6%) for the early AFX. The risk of reintervention for patients who received the early AFX device was higher compared with the other devices in propensity matched Cox models (hazard ratio 1.61, 95% confidence interval 1.29 to 2.02) and analyses using a surgeon level instrumental variable of >33% AFX grafts used in their practice (1.75, 1.19 to 2.59). The linked registry claims surveillance data identified the increased risk of reintervention with the early AFX device as early as mid-2013, well before the first regulatory warnings were issued in the US in 2017. CONCLUSIONS: The linked registry claims surveillance data identified a device specific risk in long term reintervention after EVAR of abdominal aortic aneurysm. Device manufacturers and regulators can leverage linked data sources to actively monitor long term outcomes in real world practice after cardiovascular interventions.
Subject(s)
Aortic Aneurysm, Abdominal , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Male , Humans , Aged , United States/epidemiology , Aged, 80 and over , Female , Aortic Aneurysm, Abdominal/epidemiology , Aortic Aneurysm, Abdominal/surgery , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis , Endovascular Procedures/adverse effects , Stents , Treatment Outcome , Retrospective Studies , Medicare , Registries , Risk FactorsABSTRACT
Peripheral artery disease (PAD) is chronic in nature, and individualized chronic disease management is a central focus of care. To accommodate this reality, tools to measure the impact and quality of the PAD care delivered are necessary. Patient-reported outcomes (PROs) and instruments to measure them, that is, PRO measures, have been well studied in the research and clinical trial context, but a shift toward integrating them into clinical practice has yet to take place. A framework to use PRO measures as indicators of the quality of PAD care delivered, that is, PRO performance measures (PRO-PMs), is provided in this scientific statement. Measurement goals to consider by PAD clinical phenotypes are provided, as well as an overview of potential benefits of adopting PRO-PMs in the clinical practice of PAD care, including reducing unwanted variability and promoting health equity. A central discussion with considerations for risk adjustment of PRO-PMs, individualized PAD care, and the need for patient engagement strategies is offered. Furthermore, necessary conditions in terms of required competencies and training to handle PRO-PM data are discussed because the interpretation and handling of these data come with great responsibility and consequences for designing care that adopts a broader framework of risk that goes beyond the inclusion of biomedical variables. To conclude, health system perspectives and an agenda to reach the next steps in the implementation of PRO-PMs in PAD care are offered.
Subject(s)
American Heart Association , Peripheral Arterial Disease , Humans , United States , Patient Reported Outcome Measures , Peripheral Arterial Disease/diagnosis , Peripheral Arterial Disease/therapy , Patient Participation , Health StatusABSTRACT
Importance: Patients with abdominal aortic aneurysm (AAA) can choose open repair or endovascular repair (EVAR). While EVAR is less invasive, it requires lifelong surveillance and more frequent aneurysm-related reinterventions than open repair. A decision aid may help patients receive their preferred type of AAA repair. Objective: To determine the effect of a decision aid on agreement between patient preference for AAA repair type and the repair type they receive. Design, Setting, and Participants: In this cluster randomized trial, 235 patients were randomized at 22 VA vascular surgery clinics. All patients had AAAs greater than 5.0 cm in diameter and were candidates for both open repair and EVAR. Data were collected from August 2017 to December 2020, and data were analyzed from December 2020 to June 2021. Interventions: Presurgical consultation using a decision aid vs usual care. Main Outcomes and Measures: The primary outcome was the proportion of patients who had agreement between their preference and their repair type, measured using χ2 analyses, κ statistics, and adjusted odds ratios. Results: Of 235 included patients, 234 (99.6%) were male, and the mean (SD) age was 73 (5.9) years. A total of 126 patients were enrolled in the decision aid group, and 109 were enrolled in the control group. Within 2 years after enrollment, 192 (81.7%) underwent repair. Patients were similar between the decision aid and control groups by age, sex, aneurysm size, iliac artery involvement, and Charlson Comorbidity Index score. Patients preferred EVAR over open repair in both groups (96 of 122 [79%] in the decision aid group; 81 of 106 [76%] in the control group; P = .60). Patients in the decision aid group were more likely to receive their preferred repair type than patients in the control group (95% agreement [93 of 98] vs 86% agreement [81 of 94]; P = .03), and κ statistics were higher in the decision aid group (κ = 0.78; 95% CI, 0.60-0.95) compared with the control group (κ = 0.53; 95% CI, 0.32-0.74). Adjusted models confirmed this association (odds ratio of agreement in the decision aid group relative to control group, 2.93; 95% CI, 1.10-7.70). Conclusions and Relevance: Patients exposed to a decision aid were more likely to receive their preferred AAA repair type, suggesting that decision aids can help better align patient preferences and treatments in major cardiovascular procedures. Trial Registration: ClinicalTrials.gov Identifier: NCT03115346.