Background:Peripheral artery disease (PAD) is an occlusive arterial disease primarily affecting the lower extremities. It impacts over 230 million people worldwide and is associated with significant morbidity and mortality. The ankle brachial index (ABI) test is a non-invasive method to detect PAD that compares the blood pressure in the ankle and arm to evaluate lower extremity blood flow. An estimated 20-50% of individuals with detectable PAD are asymptomatic and remain undiagnosed; however, ABI screening in high-risk, asymptomatic populations is not currently guideline-recommended. Few studies have evaluated change in ABI over time in asymptomatic populations. Therefore, we aimed to identify distinct trajectories of ABI values from mid-to late-life. Methods:We utilized data from the Atherosclerosis Risk in Communities (ARIC) study; a longitudinal cohort study initiated in 1987 that enrolled 15,792 participants aged 45-64. ABI measurements were collected at five visits over a 30-year period. We used group-based trajectory modeling to identify trajectories of ABI from mid-to late-life. Final model selection was based on visual fit, statistical criteria, group sizes, and substantive knowledge. Lastly, we compared baseline demographics, social determinants of health, and overall cardiovascular (CV) health, assessed using the American Heart Association's Life's Essential 8 (LE8) framework, across trajectory groups. Results:We identified 4,121 participants with ≥3 ABI measurements over the study period in at least one limb. At baseline, participants had an average age of 51.4 ± 4.9 years, were 57.3% female, 22.2% Black, and had an average overall LE8 score of 68.0 ± 13.9 points. Our final model identified three linear trajectories: low-normal, high-normal, and declining. Overall LE8 scores varied significantly across trajectory groups: 67.3 ± 10.7 (high-normal), 61.9 ± 13.3 (low-normal), and 50.1 ± 15.8 points (declining). Women had lower average ABI values, were more likely to experience a declining ABI trajectory, and had a delayed onset of decline compared to men. A greater proportion of Black participants experienced declining ABIs, with earlier, faster, and more severe declines than White participants. Conclusions:Poor overall CV health and common CV risk factors are associated with ABI decline. Targeted ABI screening in middle age may help detect PAD in its beginning stages and support early intervention.
Introduction Peripheral artery disease (PAD) and chronic limb-threatening ischemia (CLTI) cause substantial morbidity and mortality, yet research progress is limited by fragmented, nonstandardized data. The Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM) provides a standardized framework for electronic health record research but lacks domain-specific detail for peripheral vascular diseases. This study aimed to develop and test a vascular-specific OMOP CDM extension to improve data standardization, enable reproducible real-world analyses, and support precision medicine research in PAD and CLTI. Methods We identified patients with PAD, CLTI, or diabetic foot ulcers who sought care within the University of North Carolina Health System between April 2014 and July 2024. Standard OMOP tables were supplemented with peripheral vascular laboratory data and North Carolina state death certificate records. Intermediate tables were designed for key clinical domains (e.g., smoking, comorbidities, revascularizations) to enhance reusability. Predictive models for revascularization and mortality were developed using logistic regression with Bayesian weighting and Markov Chain Monte Carlo feature selection. Results The revascularization model displayed high performance with and without important vascular variables (area under the curve [AUC] = 0.970 and AUC 0.969, respectively), while the mortality model demonstrated moderate accuracy (AUC = 0.656) that improved with inclusion of vascular-specific features (AUC = 0.752). Conclusions This vascular OMOP extension represents one of the first specialty-specific frameworks for peripheral vascular research. By extending the OMOP CDM to a vascular domain, this work advances both the technical framework and scientific capability of real-world data research in limb preservation and precision vascular medicine.
Objective To characterise the reporting practices of sequential multiple assignment randomised trials (SMARTs) in human health research.Design Scoping review of protocol and primary analysis papers describing SMARTs published between January 2009 and February 2024.Background SMARTs are innovative trial designs that allow for multiple stages of randomisation to treatment, with randomization potentially based on a patient’s response(s) to previous treatment(s). They are uniquely designed to develop sequential adaptive interventions (dynamic treatment regimes (DTRs)) to support personalized clinical decision-making over time. Previous reviews have identified inconsistencies in how the design, implementation and results of SMARTs have been reported in published studies. A comprehensive assessment of SMART reporting practices is lacking and necessary for developing standardised SMART-specific reporting guidelines.Methods We systematically searched multiple databases for SMART-related protocol and primary analysis papers published between January 2009 and February 2024. Title, abstract and full-text screenings were performed by pairs of reviewers, with disagreements resolved by consensus. Data extraction included study characteristics, design elements and analytical approaches for embedded or tailored DTRs. Results were synthesised qualitatively and presented descriptively.Results From 5486 screened studies, 103 (59 protocol papers, 16 primary analysis papers, 14 protocol papers with corresponding primary analysis papers) met the inclusion criteria. Most studies targeted adults (62.7% protocols, 62.5% primary analyses, 42.9% protocol+primary analyses) and were primarily conducted in the USA. Behavioural and mental health constituted the most frequent therapeutic domain. While intervention descriptions and re-randomisation criteria were consistently reported, operational characteristics such as blinding (protocols: 64.4%, primary analyses: 62.5%, protocols+primary analyses: 71.4%) and randomisation details (protocols: 55.9%, primary analyses: 37.5%, protocols+primary analyses: 50.0%) were inconsistently documented. Only 46.7% of primary analyses evaluated embedded DTRs, and none explored deeply tailored DTRs.Conclusions Despite the increased adoption of SMART designs, substantial reporting variability persists. Most primary analyses underuse the capability of SMARTs to generate data for developing DTRs. SMART-specific standardised reporting guidelines can help accelerate the scientific and clinical impact of SMARTs.
Objective The optimal timing of revascularization in patients with mild-to-moderate chronic limb-threatening ischemia (CLTI) remains unclear. We aimed to evaluate long-term outcomes associated with conservative-first vs early revascularization strategies in patients with Wound, Ischemia, and foot Infection (WIfI) stage 1-2 CLTI. Methods A 10-year, retrospective two-center analysis of patients with WIfI stage 1-2 CLTI was conducted. At both centers, the standard practice is to revascularize patients with toe pressure <30 mm Hg, whereas those with less severe ischemia are typically offered an initial trial of conservative management (wound care and offloading). However, through shared decision-making, some patients with toe pressure >30 mm Hg may still opt for—and be offered—immediate revascularization. Patients were grouped into conservative care only, late revascularization, and early revascularization, defined as intervention <30 days from presentation. Outcomes were wound healing, major limb amputation, amputation-free survival (AFS), and mortality. Results During the study period, 1404 patients were treated at two limb preservation centers, of whom 512 (36.5%) with WIfI stage 1 or 2 limbs were analyzed (573 limbs; median age 65 years, interquartile range: 57-74 years; 60.7% male; median follow-up 852 days, interquartile range: 346-1415 days). AFS was longest in the late revascularization group (median 3677 days), followed by early revascularization (1756 days), and shortest in the conservative care only group (1513 days) (P < .001). Limb salvage was achieved in 88% of conservative, 89% of early, and 91% of late revascularization patients, with no significant differences (P = .83). Overall survival was 54.2% in the conservative group, 71.9% in the early revascularization group, and 76.4% in the late revascularization group (P = .048). On multivariable analysis, conservative care only (hazard ratio [HR]: 0.41, 95% confidence interval: 0.25-0.66) and WIfI stage 2 (HR: 0.69, 95% confidence interval: 0.48-0.99) were protective, whereas increasing age (HR: 1.02, P = .004), congestive heart failure (HR: 1.73, P < .001), and bypass occlusion (HR: 1.74, P = .025) predicted major amputation/death. In patients with ischemic wounds, survival and AFS remained highest in the late revascularization group, with no significant differences in wound healing or major amputation. Conclusions In patients with WIfI clinical stages 1 and 2, early revascularization was not associated with improved AFS or wound healing compared with conservative management with or without delayed revascularization. These findings suggest that a selective, staged approach may be safe and effective in appropriately selected low- to moderate-risk CLTI patients.
To investigate which preoperative factors are most impactful on the 5-year survival of patients undergoing fenestrated/branched endovascular aortic repair (F/BEVAR) and to identify modifiable elements that, if time allows, should be actively managed and adequately controlled preoperatively.
The aim of this study was to compare the outcomes of F/BEVAR patients treated with and without concomitant endovascular hypogastric preservation. This single-center retrospective cohort included patients with a diagnosis of Crawford types I-IV thoracoabdominal aneurysms (TAAAs), suprarenal or juxtarenal aortic aneurysms treated with either a patient-specific company-manufactured device (CMD) or an off-the-shelf device. Patients were divided into 2 groups:F/BEVAR (group-A) and F/BEVAR + iliac device (group-B). Patients in group-B had their iliac artery aneurysm treated either with an IBD (Zenith Branch Endovascular Graft ZBIS–Iliac Bifurcation–by Cook Medical), an IBE (iliac branch endograft,IBE,by Gore), or with an investigational patient-specific manufactured iliac fenestrated graft (by Cook Medical). Patients with implanted iliac devices prior to the F/BEVAR or with parallel stenting into the iliac system were excluded from the study. Primary outcomes were 30-day survival, freedom from secondary interventions (SIs), and long-term patency of the IB graft. Secondary outcomes included perioperative adverse events considering the first 30 days post-intervention and long-term survival. Four hundred ten patients treated between July/2012-February/2023 were included, 391 in group-A and 19 in group-B. Four cases in group-B had bilateral implantation of iliac grafts. The two groups were similar in terms of demographics and comorbidities. There was no difference between the groups in terms of aneurysm extent (P = .759). Mean follow-up for groups A and B were 33.6 ± 22.6 and 23.8 ± 20.1 months, respectively (P = .06). For patients in group-B, a larger volume of contrast was used (P = .007) and the duration of the procedure was longer (P = .003), as well as fluoroscopy time (P = .002) (Table I). As for the perioperative variables, there was no significant difference between the groups in terms of major cardiovascular events (P = .240), and the 30-day mortality was 2% in group-A and 0% in group-B (P > .99). There were 11 cases of spinal cord ischemia (2.8%) in group-A, but none in group-B. Considering long-term results, time-to-event analyses did not demonstrate a significant difference in freedom from SI (Log-rank P = .945) or long-term survival (Log- rank P = .545) (Fig 1) between the groups. Primary patency of the iliac grafts was 94.4% at 1 and 3 years. The incidence of Type Ib endoleak in group-A was 2.3% and 0% in group-B (P > .99). F/BEVAR for complex aortic aneurysms can be safely performed concomitantly with the endovascular treatment of common iliac artery aneurysms using iliac branched or fenestrated grafts. Despite the longer duration of the procedures, longer fluoroscopy times, and higher doses of contrast, these patients do not present significant differences in terms of short and long-term outcomes when compared to the ones that were submitted to a F/BEVAR alone.TableMain aortic device typeDevice typeF/BEVAR (n = 391)F/BEVAR + IBD/IBE (n = 19)P valueCMD356 (91.1)17 (89.4)>.99p-branch22 (5.6)1 (5.3)>.99t-branch13 (3.3)1 (5.3)>.99Intraoperative dataVariablesF/BEVAR (n = 391)F/BEVAR + IBD/IBE (n = 19)P valueEBL281.1 ± 599.3258.3 ± 279.3.755Procedure duration, minutes246.6 ± 93.8309.7 ± 77.2.003Fluoroscopy time, minutes79.4 ± 43.3114.1 ± 40.9.002Air kerma, mGy1808.52159.3.384Contrast volume, mL94.2 ± 42.6145.66 ±70.3.007Early outcomes (first 30-day period)VariablesF/BEVAR (n = 391)F/BEVAR + IBD/IBE (n = 19)P value30-day mortality8 (2)0 (0)>.99AKI (RIFLE criteria)17(4.3)1(5.2).542Spinal cord ischemia11 (2.8)0 (0)>.99MACE45 (11.5)0 (0).24030-day secondary interventions18 (4.6)0 (0)>.99Access complications50 (12.7)0 (0).146Bowel ischemia5(1.3)1 (5.3).249Postopertive hospital stay length, days5.08 ± 6.27.39 ± 15.527AKI, Acute kidney injury; CMD, custom-manufactured device; EBL, estimated blood loss; MACE, major adverse cardiovascular events.Data are presented as the total number (%) or mean ± standard deviation. Open table in a new tab
Precision medicine is a promising framework for generating evidence to improve health and health care. Yet, a gap persists between the ever-growing number of statistical precision medicine strategies for evidence generation and implementation in real-world clinical settings, and the strategies for closing this gap will likely be context-dependent. In this paper, we consider the specific context of partial compliance to wound management among patients with peripheral artery disease. Using a Gaussian process surrogate for the value function, we show the feasibility of using Bayesian optimization to learn optimal individualized treatment rules. Further, we expand beyond the common precision medicine task of learning an optimal individualized treatment rule to the characterization of classes of individualized treatment rules and show how those findings can be translated into clinical contexts.
OBJECTIVE:To investigate which preoperative factors most impact the 5-year survival of patients undergoing fenestrated/branched endovascular aortic repair (F/BEVAR) and to identify modifiable elements that, if time allows, should be actively managed and adequately controlled preoperatively. METHODS:Patients treated for aortic aneurysms with complex anatomy using either patient-specific company-manufactured or off-the-shelf F/BEVAR devices were included. The exposure of interest was aneurysm type (group I: type I-III thoracoabdominal aneurysms vs group II: type IV thoracoabdominal aneurysms vs group III: juxtarenal or suprarenal aneurysms), and the primary outcome was 5-year risk of all-cause mortality. Generalized linear models were used to estimate each group's crude 5-year risk of death and the 5-year risk of death across groups. Each preoperative factor was added to the model individually, and a change in estimate was calculated between the new risks and the crude risk. Preoperative factors with a change of estimate of ≥10% were used to create an inverse probability of treatment weights for multivariable analysis. RESULTS:A total of 408 F/BEVAR patients were included, of whom 71.6% were male (mean age: 72.0 ± 7.9 years). Eleven of the 22 preoperative factors analyzed had a change in estimate ≥10%. The greatest changes in estimates were observed for history of congestive heart failure (CHF), arrhythmia, overweight, obesity, and chronic obstructive pulmonary disease. Almost 60% of patients with CHF in group I died within 5 years. Current smoking or overweight at the time of F/BEVAR increases the 5-year risk of death more significantly than having a history of myocardial infarction. After adjustment, patients in group I had a significantly higher risk of 5-year all-cause mortality than those in group III (log-rank, P value = .0082). CONCLUSIONS:The present findings suggest that cardiac arrhythmias, CHF, overweight, obesity, chronic obstructive pulmonary disease, and aneurysm diameter above 7 cm are the most relevant preoperative factors that impact the 5-year survival after F/BEVAR. More specifically, CHF and arrhythmias should be used to alter patient selection and identify those individuals more likely to benefit from repair. Moreover, modifiable risk factors such as weight loss and smoking cessation during the surveillance period before the F/BEVAR procedure might improve survival in this population. Considering that, preoperatively, many patients are periodically evaluated by a vascular surgery team until the aneurysm diameter meets criteria for repair, a multidisciplinary approach that could address these modifiable risk factors might be an impactful strategy.
ObjectivesTo evaluate the effect of fenestration configuration and fenestration gap on renal artery outcomes during fenestrated-branched endovascular aortic repair (F/BEVAR).MethodsA retrospective multicenter analysis was performed, including patients with complex aortic aneurysms treated with F/BEVAR that incorporated at least one small fenestration to a renal artery. The renal fenestrations were divided into groups 1 (8x6 mm) and 2 (6x6 mm). Primary patency, target vessel instability (TVI), freedom from secondary interventions (SIs), occurrence of type IIIc endoleak, all related to the renal arteries, were analyzed at 30-day, 1-year, and 5-year landmarks. The fenestration gap (FG) distance was analyzed as a modifier, and clustering was addressed at the patient level.ResultsSeven hundred and ninety-six patients were included in this study, 71.7% male, with a mean age of 73.3±8.1 years. The mean follow-up was 30.0±20.6 months. Of the 1474 small renal fenestrations analyzed, 47.6% were 8x6, and 52.4% were 6x6mm. At the 30-day landmark, primary patency (99.9% vs 98.0%, p-value <0.001 for groups 1 and 2, respectively), freedom from TVI (99.6% vs 97.1%, p-value <0.001 for groups 1 and 2, respectively), and freedom from SI (99.8% vs 98.4%, p-value = .022 for groups 1 and 2, respectively) were higher in 8x6 compared to 6x6 fenestrations, and the incidence of AKI was similar across the groups (92.6% vs 92.7%, p-value = .953 for groups 1 and 2 respectively). The primary patency at 1 and 5 years was higher in 8x6 fenestrations (1-year: 98.8% vs 96.9%; 5-year: 97.8% vs 95.7%, for groups 1 and 2, respectively, p values = .010 and 0.021 for 1 and 5 year comparisons, respectively). The freedom from SIs was significantly higher among 6x6 fenestrations at 5 years (93.1% vs 96.4%, for groups 1 and 2, respectively, p value = .007). The groups were equally as likely to experience a type Ic endoleak (1.3 % and 1.6% for 8x6 and 6x6mm fenestrations, respectively, p = .689). The 6x6 fenestrations were associated with higher risk of kidney function deterioration (17.8%) when compared with 8x6 fenestrations (7.6%) at 5 years (p <.001). The risk of type IIIc endoleak was significantly higher among 8x6 fenestrations at 5 years (4.9% and 2% for 8x6 and 6x6 mm fenestrations, respectively, p= .005). A FG ≥5 mm negatively impacted the cumulative 5-year freedom from TVI (group 1: FG ≥5 mm = 0.714, FG <5 mm = 0.857, p<.001; group 2: FG ≥5 mm = 0.761, FG <5 mm = 0.929, p<.001) and the cumulative 5-year freedom from type IIIc endoleak (group 1: FG ≥5 mm = 0.759, FG <5 mm = 0.921, p=.034; group 2: FG ≥5 mm = 0.853, FG <5 mm = 0.979, p<.001) in both groups and the cumulative 5-year patency in group 2 (group 1: FG ≥5 mm = 0.963, FG <5 mm = 0.948, p=.572; group 2: FG ≥5 mm = 0.905, FG <5 mm = 0.938, p=.036).ConclusionsFenestration configuration for the renal arteries impacts outcomes. The 8x6 small fenestrations have better patency at 30-days, 1 year, and 5 years, while 6x6 small fenestrations are associated with lower rates of secondary interventions, primarily due to a lower incidence of type IIIc endoleaks. Fenestration gap ≥ 5 mm at the level of the renal arteries significantly impacts the freedom from TVI, freedom from type IIIc endoleak and 5-year patency independently of the fenestration size or vessel diameter.
The aim of this study was to evaluate the outcomes of renal fenestrations with large gap distance compared to the results of renal branches This was a retrospective, single-center, non-randomized study including patients with a diagnosis of complex aortic aneurysm that underwent a fenestrated/branched endovascular repair (F/BEVAR) under a PSIDE protocol. Patients with at least one renal artery incorporated in the repair, either through a fenestration or a branch, were included in the analysis. Fenestrations were typically preferred over branches, especially for upward renal arteries, in an effort to optimize renal outcomes. Only large gap fenestrations (LGF) ≥5mm were included in the study and compared to branch outcomes including renal artery patency, renal instability (TVI), and renal-related secondary interventions. The branches were evaluated considering their tortuosity index (TI) (Figs 1 and 2). A TI >1.15 was previously established in the literature as a predictor of branch complications. One-hundred-fifty-six patients from a single institution (69.1% male; mean age, 71.22 ± 7.2 years), treated with F/BEVAR, were included in the analysis. The renal arteries were incorporated in the repair through 157 LGF (26 with 6 × 6 mm configuration; 131 with an 8 × 6 mm configuration) and 100 branches. Mean aneurysm diameter was similar in both groups (branches: 65 ± 14.0 mm, fenestrations: 64.1 ± 11.9 mm; P = .58). Mean renal artery diameter was 5.4 ± 1.1 mm in the branch group and 5.5 ± 1.5mm in the fenestration group (P = .91). The risk of TVI was significantly higher for LGF compared to renal branches (RR, 3.53; P = .0059). Similarly, the risk of TVI was significantly higher in LGF irrespective of fenestration configuration (6 × 6 mm: RR, 4.00; P = .0189; 8 × 6 mm: RR, 3.49; P = .007) compared to branches. Renal patency was not statistically different between LGF and branches (6 × 6 mm: P = .074; 8 × 6 mm: P = .973, all fenestrations P = .558). The same result was observed for secondary interventions (6 × 6 mm: P = .154; 8 × 6 mm: P = .112; all fenestrations P = .096). Mean branch tortuosity was 1.3 ± 0.2 mm. The risk of TVI was significantly higher in fenestrations associated with FG >5 mm when compared to renal branches associated with a TI >1.15 (6 × 6 mm fenestrations: RR, 3.80; P = .032; 8 × 6 mm fenestrations: RR, 3.32; P = .017). No difference was observed when both fenestration configurations were compared to the renal branches with TI >1.15 in terms of loss of renal patency and renal secondary interventions. The present results suggest that renal branches, even when associated with a high TI, are less detrimental to renal artery instability when compared to large gap renal fenestrations. Custom-manufactured device renal designs with large gap fenestrations should be avoided when possible in favor of branch configurations.Fig 2Illustration of tortuosity index (TI) measurement (3D image of a CT angiography): a = centerline length measurement; b: linear measurement; TI = a/b. H = head; F = feet.View Large Image Figure ViewerDownload Hi-res image Download (PPT)
Chronic limb-threatening ischemia (CLTI) is associated with significant morbidity, including major limb amputation, and mortality. Healing ischemic wounds is necessary to optimise vascular outcomes and can be facilitated by dedicated appointments at a wound clinic. This study aimed to estimate the association between successful wound care initiation and 6-month wound healing, with specific attention to differences by race/ethnicity. This retrospective study included 398 patients with CLTI and at least one ischaemic wound who scheduled an appointment at our wound clinic between January 2015 and July 2020. The exposure was the completion status of patients' first scheduled wound care appointment (complete/not complete) and the primary outcome was 6-month wound healing (healed/not healed). The analysis focused on how this association was modified by race/ethnicity. We used Aalen-Johansen estimators to produce cumulative incidence curves and calculated risk ratios within strata of race/ethnicity. The final adjustment set included age, revascularization, and initial wound size. Patients had a mean age of 67 ± 14 years, were 41% female, 46% non-White and had 517 total wounds. In the overall cohort, 70% of patients completed their first visit and 34% of wounds healed within 6-months. There was no significant difference in 6-month healing based on first visit completion status for White/non-Hispanic individuals (RR [95% CI] = 1.18 [0.91, 1.45]; p-value = 0.130), while non-White individuals were roughly 3 times more likely to heal their wounds if they completed their first appointment (RR [95% CI] = 2.89 [2.66, 3.11]; p-value < 0.001). In conclusion, non-White patients were approximately three times more likely to heal their wound in 6 months if they completed their first scheduled wound care appointment while White/non-Hispanic individuals' risk of healing was similar regardless of first visit completion status. Future efforts should focus on providing additional resources to ensure minority groups with wounds have the support they need to access and successfully initiate wound care.
Objective: The pedal medial arterial calcification (MAC) score has been associated with risk of major limb amputation in patients with chronic limb-threatening ischemia. This study aimed to validate the pedal MAC scoring system in a multi-institutional analysis to validate its usefulness in limb amputation risk prediction. Methods: A multi-institution, retrospective study of patients who underwent endovascular or open surgical infrainguinal revascularization for chronic limb-threatening ischemia was performed. MAC scores of 0 to 5 were assigned based on visible calcified arteries on foot X ray then trichotomized (0-1, 2-4, 5) for analysis. The primary outcome was major limb amputation at 6 months. Adjusted Kaplan-Meier models were used to analyze time-to-major amputation across groups. Results: There were 176 patients with 184 affected limbs (mean age, 66 years; 61% male; 60% White), of whom 97% presented with a wound. The MAC score was 0 in 41%, 1 in 9%, 2 in 13%, 3 in 11%, 4 in 13%, and 5 in 13% of the limbs. There were 26 major amputations (14%) and 16 deaths (8.7%) within 6 months. Patients with MAC 5 had a significantly higher risk of major limb amputation than both the 0 to 1 and 2 to 4 groups (P = .001 and P = .044, respectively), and lower overall amputation-free survival (log-rank P = .008). Conclusions: Pedal MAC score is a reproducible and generalizable measure of inframalleolar arterial disease that can be used with Wound, Ischemia, and foot Infection staging to predict major limb amputation in patients with chronic limb-threatening ischemia. (J Vasc Surg 2023;78:1286-91.)
Palliative care (PC) is often introduced shortly before the end of life when benefits are likely to be limited. We aimed to evaluate differences in PC referral rates by gynecologic cancer types stratified by race.
Background: Among patients with peripheral artery disease (PAD), depression is diagnosed in 17-25% and negatively impacts wound healing, quality of life, and survival. We hypothesized that depression is underdiagnosed in patients with PAD. Additionally, given the associations between depression and mortality in PAD patients, there is an increased need to investigate the strength of this relationship. The present analysis includes 2 studies to address the following aims: (1) Investigation of the prevalence of concomitant PAD and depression in a cohort from the Southeastern United States, and (2) Examination of the association between depression and all-cause mortality in a cohort of Canadian patients with PAD.Methods: STUDY 1: From June-August 2022, the Patient Health Questionnaire Module 9 (PHQ-9) was administered to all patients seeking PAD-related care including medical, wound/ podiatric, or vascular interventional/surgical treatment, in the University of North Carolina Chapel Hill Vascular, Wound, and Podiatry clinics. The PHQ-9 assesses symptoms over 2 weeks and is scored 0-27, with higher scores indicating increasingly severe depression. Demographics, primary diagnosis, depression history, and antidepressant prescription were determined through chart review. We compared the proportion of positive depression screenings (PHQ-9 >= 5) to known depression. Among those treated for depression, the PHQ-9 score severity was evaluated. T-tests and chi(2) tests were used to compare means and proportions. STUDY 2: From July 2015 to October 2016, the Geriatric Depression Scale Short Form was administered to adult patients with PAD undergoing revascularization. The Geriatric Depression Scale Short Form is a self-report measure of depression with a score >5 consistent with depression. The prevalence of depression was determined; primary outcome was all-cause mortality at 6 months.Results: STUDY 1: In 104 PAD patients (mean age 66.6 +/- 11.3 years, 37% female), 37% of respondents scored >= 5 on the PHQ-9 survey, indicating at least mild depression. Only 18% of PAD patients had a history of depression, demonstrating a significant difference between the PHQ-9 findings and documented medical history. While depression was underdiagnosed in both men and women, men were more likely to have unrecognized depression (chi-squared statistic = 35.117, df = 1, P < 0.001). Among those with a history of depression, 74% had a current prescription for antidepressant medication, but 57% still had an elevated PHQ-9 score indicating possible undertreatment. STUDY 2: In 148 patients (mean age 70.3 +/- 11.0 years, 39% female) the prevalence of screened depression was 28.4%, but only 3.3% had a documented history of depression suggesting significant underdiagnosis. Patients with depression were significantly more likely to die within 6 months of revascularization (9.5% vs. 0.9%; odds ratio 1.48, 95% confidence interval: 1.08 to 2.29). There was no association between depression and risk of length of stay, reintervention, or readmission.Conclusions: Depression is underdiagnosed and undertreated among patients with PAD, which has grave consequences as it is associated with 1.5 times the odds of mortality within 6 months of revascularization. There is a critical need for more robust screenings and comprehensive mental health treatment for patients with concomitant depression and PAD.
Older adults are characterized by profound clinical heterogeneity. When designing and delivering interventions, there exist multiple approaches to account for heterogeneity. We present the results of a systematic review of data-driven, personalized interventions in older adults, which serves as a use case to distinguish the conceptual and methodologic differences between individualized intervention delivery and precision health-derived interventions. We define individualized interventions as those where all participants received the same parent intervention, modified on a case-by-case basis and using an evidence-based protocol, supplemented by clinical judgment as appropriate, while precision health-derived interventions are those that tailor care to individuals whereby the strategy for how to tailor care was determined through data-driven, precision health analytics. We discuss how their integration may offer new opportunities for analytics-based geriatric medicine that accommodates individual heterogeneity but allows for more flexible and resource-efficient population-level scaling.
Purpose of Review This review aims to summarize the current burden of heart failure (HF) in the United States, specifically in patients with low socioeconomic position (SEP), and synthesize recommendations to prevent HF-related hospital readmissions in this vulnerable population. Recent Findings As treatments have improved, HF-related mortality has declined over time, resulting in more patients living with HF. This has led to an increase in hospitalizations, however, putting excess strain on our healthcare system. HF patients with low SEP are a particularly vulnerable group, as they experience higher rates of hospitalization and readmission compared to their high SEP counterparts. The Hospital Readmission Reduction Program (HRRP) was created to motivate interventions that reduce hospital readmissions across diseases, with HF being a primary target. Numerous readmission prevention efforts have been suggested to target the pre-hospitalization, hospitalization, and post-hospitalization phases, including addressing social determinants of health (SDoH), improving coordination of care, optimizing discharge plans, and improving adherence to follow-up care and medication regimens. Many of these proposed interventions show promise in reducing HF-related readmissions and issues surrounding adequate caregiver support may be particularly important to reduce readmissions among persons in low SEP. Summary Reducing HF-related hospital readmissions is possible, even in vulnerable populations like those with low SEP, but this will require coordinated efforts across the healthcare system and throughout the life course of these patients. Caregiver support is a necessary part of optimized care for low SEP HF patients and future efforts should consider interventions that support these caregivers.
Weak evidence, when manifested in clinical guidelines, can translate into biased vascular care. In vascular surgery, we have few randomized controlled trials with appropriate representation of females and persons of color, so generalizability of trial results can be problematic. Physicians are required to balance evidenced-based care (which is only as good as the underlying evidence) with personalized treatment recommendations that are often based on demographics, social circumstances, and/or existing therapeutic relationships. Biases, whether implicit or explicit, have an oversized effect on treatment decisions, and patient outcomes. In this commentary, we propose three principles to strengthen the vascular surgery evidence foundation and patient-centered decision-making going forward: (1) generating evidence designed for individualized care, (2) constructing clinical guidelines that are context specific and complexity aware, and (3) strengthening the training and support for surgeons to deliver patient-centered individualized care.
Precision medicine is a promising framework for generating evidence to improve health and health care. Yet, a gap persists between the ever-growing number of statistical precision medicine strategies for evidence generation and implementation in real world clinical settings, and the strategies for closing this gap will likely be context dependent. In this paper, we consider the specific context of partial compliance to wound management among patients with peripheral artery disease. Through the use of a Gaussian process surrogate for the value function, we expand beyond the common precision medicine task of learning an optimal dynamic treatment regime to characterization of classes of dynamic treatment regimes and how those findings can be translated into clinical contexts.
Background: The traditionally reported outcomes for patients with ischemic wounds have centered on amputation-free survival. However, that discounts the importance of other patient-centered outcomes such as the wound healing time (WHT) and wound-free period (WFP). We evaluated the long-term wound outcomes of patients treated for chronic limb-threatening ischemia at our institution. Methods: From 2014 to 2017, we identified all patients with chronic limb-threatening ischemia and ischemic wounds using symptomatic and hemodynamic criteria. The primary data included the wound size, wound location, WIfI (wound, ischemia, foot infection) grade, WHT, WFP, minor and major amputation, and death. Wounds were not considered healed if the patient had required a major amputation or had died before wound healing. The WHT was calculated as the interval in days between the diagnosis and determination of a healed wound. The WFP was calculated as the interval in days between a healed wound and wound recurrence, major amputation, death, or the end of the study period. A comparison of the wound healing parameters stratified by revascularization status was performed using the Student t test. A generalized linear model adjusted for age, sex, initial wound size, and WIfI grade was used to evaluate the risk of wound healing with and without revascularization. Results: A total of 256 patients had presented with 372 wounds. Of the 256 patients, 48% had undergone revascularization. During the study period, 97 minor amputations and 100 major amputations had been required, and 132 patients had died. The average wound size was 13.9 +/- 52.0 cm(2); however, for the 155 wounds that had healed, the average size was only 4.0 +/- 9.6 cm(2) (P = .002). No differences were found in the wound size when stratified by revascularization status (P = .727). Adjusted for the initial wound size, the risk of wound healing was not different when stratified by revascularization (risk ratio, 1.22; 95% confidence interval, 0.80-1.87; P = .354). For those whose wounds had healed, the average WHT and WFP were 173 +/- 169 days and 775 +/- 317 days, respectively. The WHT was not faster for the revascularized group (155 days vs 188 days; P = .221). When stratified by revascularization status, the rate of wound recurrence was 4.6 vs 8.9 wounds per 100 person-years for the revascularized and nonrevascularized groups, respectively (P = .125). Conclusions: In our study, we found that, except for patients who presented with severe ischemia, revascularization was not associated with improved rates of wound healing. Among the wounds that healed, regardless of the initial ischemia grade, revascularization was not associated with a faster WHT or longer WFPs.