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BACKGROUND: Identifying predictors of generic and disease-specific health status outcomes in patients with lower extremity peripheral artery disease (PAD) who undergo femoral-popliteal peripheral vascular intervention (PVI) for claudication remains an under-studied area. We aimed to identify important predictors of health status after PVI as the foundation for risk-based approaches to deploying therapies that improve patient outcomes. METHOD: Baseline characteristics of 468 participants with claudication and femoral/popliteal stenosis treated with either the Stellarex paclitaxel-based drug coated balloon (DCB) or plain balloon angioplasty (PTA) from 2013 -2019 were included. The study examined 59 baseline variables and aimed to identify the most important predictors of generic (EQ-5D-3L and EQ-5D visual analogue scale [VAS]) and disease specific (Walking improvement Questionnaire [WIQ]) health status at 1 year. A random forest model was used to generate a rank variables based on their importance in predicting 1-year health status. RESULTS: Among included patients, mean ± SD age was 68.3 ± 9 years with 67.9% and 87% being male and white respectively. Baseline mean EQ-5D-3L, EQ-5D VAS and WIQ were 0.7 ± 0.3, 64.6± 16.0 and 30.7± 22.1, respectively. The most important variables for predicting EQ-5D-3L, EQ-5D VAS, and WIQ were a history of deep venous thrombosis, chronic lung disease and hypertension, respectively. CONCLUSION: Among patients undergoing PVI for claudication, comorbidities were the most important predictors of future health status, underscoring the need for an integrated approach for PAD disease management. Utilization of machine learning approaches can facilitate development of models to inform risk-based approaches to treatment.
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BACKGROUND: Healthcare utilization for patients with peripheral artery disease (PAD) is high, but stratifying patients' risk of hospitalization at initial evaluation is challenging. We examined the association between health status at PAD presentation and risk of (1) combined all-cause hospital admissions and emergency department (ED) visits and (2) all-cause hospital admissions. METHODS: Patients with claudication enrolled at US sites in the PORTRAIT registry were included. Health status was assessed using the Peripheral Artery Questionnaire (PAQ), a PAD-specific patient-reported outcome measure. Crude overall and cause-specific hospital admissions and ED visits were reported by PAQ overall summary score (PAQ-OS) ranges (0-24, 25-49, 50-74, and 75-100). Kaplan-Meier survival and unadjusted and adjusted Cox proportional hazards models examined the association between baseline PAQ scores and (1) combined all-cause hospital admissions or ED visits and (2) all-cause hospital admissions over 12 months. RESULTS: Of 796 patients, 349 (44%) had a hospital admission or ED visit over 12 months. Patients in the lowest (PAQ-OS = 0-24) versus the highest range (PAQ-OS = 75-100) had higher rates of 12-month (53.3% vs 22.4%) hospital admission and ED visits. In the adjusted model, each 10-point decrease in PAQ-OS was associated with a higher risk of all-cause hospital admission and ED visits (HR = 1.1, 95% CI 1.1-1.2, p < 0.0010) and all-cause hospital admission (HR = 1.1, 95% CI 1.1-1.2, p < 0.0010) at 12 months. CONCLUSION: PAD-specific health status is associated with an increased risk of healthcare utilization. Baseline health status may help stratify risk in patients with PAD, although replication and further validation of results are necessary.
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INTRODUCTION: The impact of cardiac function decline on major adverse limb events (MALE) following lower extremity revascularization (LER) in patients with peripheral arterial disease (PAD) has not been described. METHODS: The electronic records of patients undergoing LER for PAD in a single center were reviewed. Two transthoracic echocardiograms were captured, the first within 6 months of LER and the second on later follow-up (most recent to date). Patients were then divided into 2 groups: cardiac function decline (decrease in left ventricular ejection fraction ΔEF ≥10%) or stable cardiac function (reduction in ΔEF <10%, no change or improved EF). Patient characteristics and outcomes, including MALE, were compared. RESULTS: Of the 926 patients who underwent LER, 222 (24.0%) experienced a cardiac function decline, with 704 (76.0%) patients having stable cardiac function. Patients with cardiac function decline were more likely to have diabetes mellitus and heart failure than patients with stable cardiac function. There were no differences in the mode of revascularization (open vs. endovascular) between both groups. Patients with cardiac function decline demonstrated higher rates of periprocedural bleeding after initial LER. After a mean follow-up of 3 years, patients with cardiac function decline had higher mortality. However, Kaplan-Meier analysis revealed no difference in freedom from MALE or reintervention rates between the 2 groups. CONCLUSION: Patients with cardiac function decline after LER for PAD have increased mortality but no significant difference in limb outcomes compared to patients with stable cardiac function.
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Background: Patients with peripheral artery disease face high amputation and mortality risk. When assessing vascular outcomes, consideration of mortality as a competing risk is not routine. We hypothesize standard time-to-event methods will overestimate major amputation risk in chronic limb-threatening ischemia (CLTI) and non-CLTI. Methods: Patients undergoing peripheral vascular intervention from 2017 to 2018 were abstracted from the Vascular Quality Initiative registry and stratified by mean age (⩾ 75 vs < 75 years). Mortality and amputation data were obtained from Medicare claims. The 2-year cumulative incidence function (CIF) and risk of major amputation from standard time-to-event analysis (1 - Kaplan-Meier and Cox regression) were compared with competing risk analysis (Aalen-Johansen and Fine-Gray model) in CLTI and non-CLTI. Results: A total of 7273 patients with CLTI and 5095 with non-CLTI were included. At 2-year follow up, 13.1% of patients underwent major amputation and 33.4% died without major amputation in the CLTI cohort; 1.3% and 10.7%, respectively, in the non-CLTI cohort. In CLTI, standard time-to-event analysis overestimated the 2-year CIF of major amputation by 20.5% and 13.7%, respectively, in patients ⩾ 75 and < 75 years old compared with competing risk analysis. The standard Cox regression overestimated adjusted 2-year major amputation risk in patients ⩾ 75 versus < 75 years old by 7.0%. In non-CLTI, the CIF was overestimated by 7.1% in patients ⩾ 75 years, and the adjusted risk was overestimated by 5.1% compared with competing risk analysis. Conclusions: Standard time-to-event analysis overestimates the incidence and risk of major amputation, especially in CLTI. Competing risk analyses are alternative approaches to estimate accurately amputation risk in vascular outcomes research.
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Amputação Cirúrgica , Isquemia Crônica Crítica de Membro , Extremidade Inferior , Doença Arterial Periférica , Sistema de Registros , Humanos , Amputação Cirúrgica/mortalidade , Doença Arterial Periférica/cirurgia , Doença Arterial Periférica/mortalidade , Doença Arterial Periférica/diagnóstico , Doença Arterial Periférica/epidemiologia , Masculino , Idoso , Feminino , Fatores de Risco , Medição de Risco , Incidência , Fatores de Tempo , Estados Unidos/epidemiologia , Extremidade Inferior/irrigação sanguínea , Isquemia Crônica Crítica de Membro/cirurgia , Isquemia Crônica Crítica de Membro/epidemiologia , Isquemia Crônica Crítica de Membro/mortalidade , Idoso de 80 Anos ou mais , Pessoa de Meia-Idade , Estudos Retrospectivos , Resultado do Tratamento , Medicare , Salvamento de MembroRESUMO
OBJECTIVES: To assess the feasibility of assessing long-term outcomes of peripheral vascular intervention (PVI) by linking data from a clinical registry to electronic health records (EHR) data from a clinical research network. DESIGN: Observational cohort study. SETTING: Vascular Quality Initiative registry linked to INSIGHT Clinical Research Network, which aggregated EHR data from multiple institutions in New York City. PARTICIPANTS: Patients receiving PVI during 1 January 2013-30 November 2021 in four centres in New York City. PRIMARY AND SECONDARY OUTCOME MEASURES: We examined the proportion of registry patients retained in EHR over time and predictors of EHR retention after year 1. We evaluated the implications of EHR attrition by examining amputation-free survival (AFS) in the observed data and predicted data when patients discontinued in the EHR were hypothesised to have increased risks of events than the observed average. RESULTS: We included 1405 patients receiving PVI (age=70.8±11.2 years, 51.3% male). Among eligible patients, 75.2% were retained in EHR through year 3. Patients who aged 75 years or above (vs <65: OR 0.34, 95% CI 0.18 to 0.62), had Medicaid (vs Medicare: OR 0.41, 95% CI 0.22 to 0.79), congestive heart failure (OR 0.54, 95% CI 0.32 to 0.90), dialysis (OR 0.47, 95% CI 0.24 to 0.91) and reduced ambulation (OR 0.34, 95% CI 0.15 to 0.75) were less likely to be retained in EHR. When discontinued patients were hypothesised to have increased risks of death or amputation than observed, AFS estimates diverged from the observed data around 6-12 months. CONCLUSIONS: Studies using registry-EHR data may benefit from the timeliness of the data but may be most appropriate to focus on short-term to intermediate-term outcomes of interventions and devices. Future research is needed to investigate the value of registry-EHR linkage in facilitating short-term to intermediate-term outcome assessment following vascular interventions and advanced statistical approaches to account for non-random missing long-term data.
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Registros Eletrônicos de Saúde , Sistema de Registros , Humanos , Registros Eletrônicos de Saúde/estatística & dados numéricos , Masculino , Feminino , Idoso , Pessoa de Meia-Idade , Cidade de Nova Iorque , Amputação Cirúrgica/estatística & dados numéricos , Idoso de 80 Anos ou mais , Estudos de Coortes , Estudos de Viabilidade , Estados UnidosRESUMO
OBJECTIVE: Tailoring resources of peripheral vascular interventions (PVIs) to those who stand to gain the most would allow for more equitable and value-based care. One way of evaluating the benefit of PVIs in patients with symptomatic peripheral artery disease is evaluating their health status and identifying predictors of health status response 12 months after the intervention. METHODS: Patients who underwent femoropopliteal PVI between March 2005 and August 2008 from the Zilver PTX randomized trial and single-arm study were combined into a single cohort for secondary data analysis. The preprocedural and 12-month health status was assessed by the EuroQol-5D-3 L (EQ-5D). First, we evaluated the 12-month EQ-5D Index (per 1-unit increase), adjusted for treatment condition and patient characteristics using a linear regression. Second, using the minimally clinically important difference threshold for the EQ-5D Index, we identified 12-month nonresponders (worsened or no change) vs responders (improved) and conducted an adjusted logistic regression model. RESULTS: A total of 513 patients were included (mean age: 67.8 ± 9.2 years; 25.1% female), with 17.8% U.S. and 82.2% non-U.S. global enrollment sites. The minimally clinically important difference for the EQ-5D was 0.058. For 12-month health status after PVI, a total of 57.9% improved, 31.4% experienced no change, and 10.7% worsened, relative to their preprocedural health status. Patients who were more likely to be nonresponders were more likely to have a history of carotid artery disease or were located at a U.S. enrolling center. CONCLUSIONS: The majority of patients reported improved or stable health status after femoral-popliteal PVI. Approximately 4 in 10 patients were nonresponders, with the highest risk for nonresponse including individuals with existing carotid disease or those undergoing PVIs in the U.S. vs non-U.S.
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Hypertension is a leading risk factor for cardiovascular morbidity and mortality. Despite the widespread availability of both pharmacological and lifestyle therapeutic options, blood pressure control rates across the globe are worsening. In fact, only 23% of individuals with high blood pressure in the United States achieve treatment goals. In 2023, the US Food and Drug Administration approved renal denervation, a catheter-based procedure that ablates the renal sympathetic nerves, as an adjunctive treatment for patients in whom lifestyle modifications and antihypertensive medications do not adequately control blood pressure. This approval followed the publication of multiple randomized clinical studies using rigorous trial designs, all incorporating renal angiogram as the sham control. Most but not all of the new generation of trials reached their primary end point, demonstrating modest efficacy of renal denervation in lowering blood pressure across a spectrum of hypertension, from mild to truly resistant. Individual patient responses vary, and further research is needed to identify those who may benefit most. The initial safety profile appears favorable, and multiple ongoing studies are assessing longer-term efficacy and safety. Multidisciplinary teams that include hypertension specialists and adequately trained proceduralists are crucial to ensure that referrals are made appropriately with full consideration of the potential risks and benefits. Incorporating patient preferences and engaging in shared decision-making conversations will help patients make the best decisions given their individual circumstances. Although further research is clearly needed, renal denervation presents a novel treatment strategy for patients with uncontrolled blood pressure.
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American Heart Association , Hipertensão , Rim , Simpatectomia , Humanos , Hipertensão/cirurgia , Hipertensão/fisiopatologia , Estados Unidos , Simpatectomia/métodos , Rim/inervação , Anti-Hipertensivos/uso terapêutico , Pressão Sanguínea/fisiologia , Ablação por Cateter/métodos , Resultado do TratamentoRESUMO
OBJECTIVE: A critical goal in the care of patients with peripheral artery disease (PAD) is to optimize their health status; that is, their symptoms, function, and quality of life. Social support has been proposed to be a predictor of disease-specific health status in patients with PAD. However, the prevalence of low perceived social support, the association with health status outcomes, and the interaction with other biopsychosocial variables, is unknown. Our aim was to assess the association of baseline perceived social support with health status at 12 months in patients with PAD. METHODS: The Patient-Centered Outcomes Related Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories (PORTRAIT) registry, which enrolled patients with PAD in the United States, the Netherlands, and Australia from 2011 to 2015, was used. Perceived social support was assessed at baseline with the Enhancing Recovery in Coronary Heart Disease Patients (ENRICHD) Social Support Inventory (ESSI), and disease-specific (Peripheral Artery Disease Questionnaire [PAQ]) and generic health status (Euro-Quality of Life Visual Analog Scale [VAS] and EQ-5D-3L Index) questionnaires were assessed at baseline and 12 months. Low social support was defined as a score of ≤3 on two items and an ESSI score of ≤18. A hierarchical mixed level linear regression model adjusting for biopsychosocial variables was used to assess the association between low perceived social support and the ESSI score with health status at 12 months. RESULTS: A total of 949 patients were included (mean age, 67.64 ± 9.32 years; 37.9% female), with low social support being present in 18.2%. Patients with low social support were more likely to not be married or to be living alone (50.0% vs 77.5%; P < .001); have more financial constraints; have more depressive, stress, and anxiety symptoms; and have lower disease-specific and generic health status at baseline and at 12 months. In the unadjusted model, low social support was associated with a -7.02 (95% confidence interval [CI], -10.97 to -3.07) point reduction in the PAQ, -7.43 (95% CI, -10.33 to -4.54) in the VAS, and -0.06 (95% CI, -0.09 to -0.03) in the EQ-5D-3L Index. Adjusting for biopsychosocial factors minimally attenuated these associations (PAQ: -6.52; 95% CI, -10.55 to -2.49; P = .002; VAS: -5.39; 95% CI, 8.36 to -2.42; P < .001; EQ-5D-3L Index: -0.04; 95% CI, -0.07 to 0.01; P = .022). The ESSI per-point score was associated with a decrease of 0.51 (95% CI, 0.18-0.85; P = .003) in PAQ and 0.46 (95% CI, 0.12-0.61; P = .004) in the VAS. CONCLUSIONS: Among patients with PAD, low social support was frequent and associated with a lower health status at 1 year independent of other biopsychosocial variables. Improving social support could improve health status and outcomes in PAD.
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Patients with peripheral artery disease (PAD) experience major cardiovascular and limb events. Antithrombotic strategies including antiplatelets and anticoagulants remain a cornerstone of treatment and prevention. Recent trials have shown heterogeneity in the response to antithrombotic therapies in patients presenting primarily with PAD when compared to those presenting primarily with coronary artery disease. In addition, there is observed heterogeneity with regards to the effects of antiplatelets and anticoagulants with respect to different outcomes including cardiovascular and major adverse limb events. This, coupled with risks of bleeding, requires a patient-centered and holistic assessment of benefit-risk when selecting antithrombotic strategies for patients with PAD. A global multidisciplinary work group was convened to evaluate antithrombotic strategies in PAD and to summarize the current state of the art. Common clinical scenarios around antithrombotic decision making were provided. Finally, insights with regard to implementation future investigation were described.
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Fibrinolíticos , Doença Arterial Periférica , Humanos , Doença Arterial Periférica/tratamento farmacológico , Fibrinolíticos/uso terapêutico , Anticoagulantes/uso terapêutico , Inibidores da Agregação Plaquetária/uso terapêuticoRESUMO
OBJECTIVE: Nutritional status plays a complex role in the pathophysiology and outcomes of chronic limb threatening ischaemia (CLTI). Undernutrition may be a modifiable risk factor. Given the variability in nutritional status concepts in CLTI outcomes studies, a systematic review examining the association between undernutrition and outcomes in patients with CLTI was conducted. DATA SOURCES: A systematic literature search of nine databases (Allied and Complementary Medicine Database [AMED], CINAHL Complete, Cochrane Library, Google Scholar, Ovid Medline, Ovid Embase, PubMed, Scopus, and Web of Science Core Collection databases) was conducted up to 23 May 2023. REVIEW METHODS: Inclusion criteria were randomised controlled trials, cohort studies, and case control studies of patients with CLTI conducted after 1982 that reported the effect size for a nutritional status measure and the outcomes of death, amputation, or a composite of the two. Two reviewers independently performed screening, data extraction, and quality assessment, with a third independent reviewer resolving conflicts. RESULTS: A total of 6 818 citations were screened, with 49 observational studies (31 from Japan) included in the review. The mean patient age ranged from 56.0 - 86.9 years. Most included patients were undergoing revascularisation. Unidimensional indicators of undernutrition (including low serum albumin, low body mass index, and zinc deficiency) as well as multidimensional measures (such as nutritional screening tool scores indicating undernutrition) were found to be associated with a statistically significant increased risk of death, amputation, and composite events in most studies. Effect sizes of the association were generally larger when multidimensional nutritional screening tools were used. However, the quality of evidence was poor, and certainty of evidence very low. CONCLUSION: Undernutrition is consistently associated with an increased risk of death and amputation in patients with CLTI, regardless of the measure used. Broader efforts to understand the framework of nutritional status and validation of nutritional screening tools in CLTI populations are needed.
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PURPOSE OF REVIEW: Peripheral artery disease (PAD) is a growing global epidemic. Women with PAD are at elevated risk of experiencing psychosocial stressors that influence the diagnosis, management, and course of their illness due to unique sex- and gender-based factors. RECENT FINDINGS: We review existing evidence for increased psychosocial risk in women with PAD with a focus on mood disorders, chronic stress, pain experiences, substance use disorders, health behaviors and illness perceptions, and healthcare access. We discuss how these factors exacerbate PAD symptomatology and lead to adverse outcomes. Existing gaps in women's vascular care are reviewed and potential solutions to bridge these gaps through psychosocial care integration are proposed. Current care paradigms for women's vascular care do not adequately screen for and address psychosocial comorbidities. Clinician education, integration of evidence-based psychological care strategies, implementation of workflows for the management of individuals with PAD and mental health comorbidities, reform to reimbursement structures, and further advocacy are needed in this space. This review provides a construct for integrated behavioral health care for women with PAD and advocates for further integration of care.
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Doença Arterial Periférica , Humanos , Feminino , Doença Arterial Periférica/terapia , Doença Arterial Periférica/psicologia , Saúde da Mulher , Estresse Psicológico , Comportamentos Relacionados com a Saúde , Fatores de Risco , Acessibilidade aos Serviços de SaúdeAssuntos
Indicadores de Qualidade em Assistência à Saúde , Sistema de Registros , Procedimentos Cirúrgicos Vasculares , Humanos , Indicadores de Qualidade em Assistência à Saúde/normas , Procedimentos Cirúrgicos Vasculares/normas , Resultado do Tratamento , Fatores de Risco , Sociedades Médicas/normas , Confiabilidade dos DadosRESUMO
Cardiovascular disease (CVD) is on the rise globally and, along with mental health conditions, will represent the largest public health burden, especially in a world impacted by climate change. Behavior, psychological mechanisms, and CVD are closely correlated. Evidence-based psychological interventions targeting behavior and psychological mechanisms exist across the CVD spectrum. This statement proposes the development of a subspecialty "cardiovascular psychology" to develop integrated pathways of behavioral care delivered to CVD populations. Scope of practice is discussed as it relates to diagnosing and treating comorbid health disorders, behavioral change interventions, pain management, lifestyle and wellbeing, neuropsychological assessment, and cognitive rehabilitation. An agenda on reforms for financials, training pathways, and diversification of the workforce is presented. Finally, normalizing the integration of behavioral health as part of CVD treatment is a shared responsibility across professional organizations and the community to realize value-based CVD care.
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BACKGROUND: Variation in the care management of repairs for ruptured infrarenal abdominal aortic aneurysms between centers and physicians, such as procedural volumes, may explain differences in mortality outcomes. First, we quantified the center and physician variability associated with 30- and 90-day mortality risk after ruptured open surgical repair (rOSR) and ruptured endovascular aneurysm repair (rEVAR). Second, we explored wheter part of this variability was attributable to procedural volume at the center and physician levels. METHODS: Two cohorts including rOSR and rEVAR procedures between 2013 and 2019 were analyzed from the Vascular Quality Initiative database. Thirty- and 90-day all-cause mortality rates were derived from linked Medicare claims data. The median odds ratio (MOR) (median mortality risk from low- to high-risk cluster) and intraclass correlation coefficient (ICC) (variability attributable to each cluster) for 30- and 90-day mortality risks associated with center and physician variability were derived using patient-level adjusted multilevel logistic regression models. Procedural volume was calculated at the center and physician levels and stratified by quartiles. The models were sequentially adjusted for volumes, and the difference in ICCs (without vs with accounting for volume) was calculated to describe the center and physician variability in mortality risk attributable to volumes. RESULTS: We included 450 rOSRs (mean age, 74.5 ± 7.6 years; 23.5% female) and 752 rEVARs (76.4 ± 8.4 years; 26.1% female). After rOSRs, the 30- and 90-day mortality rates were 32.9% and 38.7%, respectively. No variability across centers and physicians was noted (30- and 90-day MORs ≈1 and ICCs ≈0%). Neither center nor physician volume was associated with 30-day (P = .477 and P = .796) or 90-day mortality (P = .098 and P = .559). After rEVAR, the 30- and 90-day mortality rates were 21.3% and 25.5%, respectively. Significant center variability (30-day MOR, 1.82 [95% confidence interval (CI), 1.33-2.22]; ICC, 11% [95% CI, 2%-36%]; and 90-day MOR, 1.76 [95% CI, 1.37-2.09]; ICC, 10% [95% CI, 3%-30%]), but negligeable variability across physicians (30- and 90-day MORs ≈1 and ICCs ≈0%) were noted. Neither center nor physician volume were associated with 30-day (P = .076 and P = .336) or 90-day mortality risk (P = .066 and P = .584). The center variability attributable to procedural volumes was negligeable (difference in ICCs, 1% for 30-day mortality; 0% for 90-day mortality). CONCLUSIONS: Variability in practice from center to center was associated with short-term mortality outcomes in rEVAR, but not for rOSR. Physician variability was not associated with short-term mortality for rOSR or rEVAR. Annualized center and physician volumes did not significantly explain these associations. Further work is needed to identify center-level factors affecting the quality of care and outcomes for ruptured abdominal aortic aneurysms.
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Aneurisma da Aorta Abdominal , Ruptura Aórtica , Procedimentos Endovasculares , Humanos , Aneurisma da Aorta Abdominal/cirurgia , Aneurisma da Aorta Abdominal/mortalidade , Masculino , Feminino , Ruptura Aórtica/cirurgia , Ruptura Aórtica/mortalidade , Idoso , Estados Unidos , Fatores de Tempo , Procedimentos Endovasculares/mortalidade , Procedimentos Endovasculares/efeitos adversos , Fatores de Risco , Medição de Risco , Idoso de 80 Anos ou mais , Resultado do Tratamento , Estudos Retrospectivos , Bases de Dados Factuais , Padrões de Prática Médica , Implante de Prótese Vascular/mortalidade , Implante de Prótese Vascular/efeitos adversos , Disparidades em Assistência à Saúde , Medicare , Hospitais com Alto Volume de Atendimentos , CirurgiõesRESUMO
OBJECTIVE: To analyze the impact of noninvasive and early invasive treatments on health status in patients with lower extremity peripheral arterial disease (PAD) without and with chronic total occlusions (CTOs) after 12 months of follow-up. METHODS: Using the international (the United States, the Netherlands, and Australia) observational longitudinal Patient-Centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories registry, we included patients with recent PAD symptoms between June 2011 and December 2015. We assessed the PAD-specific health status at initial visit and the 3-, 6-, and 12-month follow-up using the Peripheral Arterial Questionnaire. On a propensity matched-weighted cohort, we compared patients' characteristics by CTO status and treatment groups as early invasive (revascularization in the 3 months) vs noninvasive (exercise, medical therapies, or smoking cessation). We then assessed the health status trajectory over 12 months, as a three-way interaction between CTO status, treatment groups, and months, using a multilevel generalized linear regression model for repeated measures adjusted for baseline health status with random effects at the site and patient levels. RESULTS: We included 581 participants, with a mean age of 66.62 ± 9.33 years, 34.3% female, and 90.8% White, of whom 353 (60.8%) were without and 228 (39.2%) had a CTO lesion. Respectively, 96 (27.2%) and 70 (30.7%) patients underwent early invasive treatment (d = 0.07). Although patients with CTO were more likely to have lower resting ABI, multilevel disease, and to experience severe claudication vs their counterparts (|d| ≥ 0.20), patient health status at baseline with CTO was not different from those without CTO, with mean summary scores of 45.14 ± 20.26 vs 45.90 ± 21.24 (d = 0.04), respectively. The trajectory did not differ by CTO status (interaction CTO status × month; P = .517) and was higher in early invasive vs noninvasive treatment (treatment × month; P < .001), regardless of CTO status (CTO status × treatment; P = .981 and CTO status × treatment × month; P = .264). The score increased over time with the largest improvement occurring at 3 months in both noninvasive (non-CTO, +7.82 [95% confidence interval (CI), 4.03-11.60] and CTO, +9.27 95% CI, 4.45-14.09) and early invasive (non-CTO, +26.17 [95% CI, 20.06-32.28] and CTO, +24.52 [95% CI, 17.40-31.64] groups. The mean score in CTO vs non-CTO groups did not differ at each timepoint, with a 12-month mean score of 70.26 (95% CI, 67.87-74.65) vs 71.17 (95% CI, 65.91-76.44) (P = .99) in the noninvasive treatment and 84.93 (95% CI, 78.90-90.97) vs 79.20 (95% CI, 72.77-86.14) (P = .31) in the early invasive treatment. CONCLUSIONS: Patients with symptomatic PAD undergoing early revascularization exhibited better health status over time vs those undergoing noninvasive treatment strategy, irrespective of the presence of CTOs. The degree of the improvement was greater in the 3 months after the initial visit, especially in patients undergoing early revascularization.
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Nível de Saúde , Doença Arterial Periférica , Sistema de Registros , Humanos , Feminino , Masculino , Idoso , Pessoa de Meia-Idade , Doença Arterial Periférica/terapia , Doença Arterial Periférica/fisiopatologia , Doença Arterial Periférica/diagnóstico , Fatores de Tempo , Resultado do Tratamento , Doença Crônica , Estados Unidos , Austrália , Países Baixos , Procedimentos Endovasculares/efeitos adversos , Extremidade Inferior/irrigação sanguínea , Tempo para o Tratamento , Fatores de Risco , Procedimentos Cirúrgicos Vasculares , Estudos LongitudinaisRESUMO
BACKGROUND: Patients with chronic limb-threatening ischemia (CLTI) face a high long-term mortality risk. Identifying novel mortality predictors and risk profiles would enable individual health care plan design and improved survival. We aimed to leverage a random survival forest machine-learning algorithm to identify long-term all-cause mortality predictors in patients with CLTI undergoing peripheral vascular intervention. METHODS AND RESULTS: Patients with CLTI undergoing peripheral vascular intervention from 2017 to 2018 were derived from the Medicare-linked VQI (Vascular Quality Initiative) registry. We constructed a random survival forest to rank 66 preprocedural variables according to their relative importance and mean minimal depth for 3-year all-cause mortality. A random survival forest of 2000 trees was built using a training sample (80% of the cohort). Accuracy was assessed in a testing sample (20%) using continuous ranked probability score, Harrell C-index, and out-of-bag error rate. A total of 10 114 patients were included (mean±SD age, 72.0±11.0 years; 59% men). The 3-year mortality rate was 39.1%, with a median survival of 1.4 years (interquartile range, 0.7-2.0 years). The most predictive variables were chronic kidney disease, age, congestive heart failure, dementia, arrhythmias, requiring assisted care, living at home, and body mass index. A total of 41 variables spanning all domains of the biopsychosocial model were ranked as mortality predictors. The accuracy of the model was excellent (continuous ranked probability score, 0.172; Harrell C-index, 0.70; out-of-bag error rate, 29.7%). CONCLUSIONS: Our random survival forest accurately predicts long-term CLTI mortality, which is driven by demographic, functional, behavioral, and medical comorbidities. Broadening frameworks of risk and refining health care plans to include multidimensional risk factors could improve individualized care for CLTI.
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Cateterismo Periférico , Isquemia Crônica Crítica de Membro , Aprendizado de Máquina , Doenças Vasculares Periféricas , Isquemia Crônica Crítica de Membro/mortalidade , Doenças Vasculares Periféricas/cirurgia , Fatores de Risco , Humanos , Algoritmo Florestas Aleatórias , Algoritmos , Masculino , Feminino , Pessoa de Meia-Idade , Idoso , Idoso de 80 Anos ou maisRESUMO
Peripheral artery disease (PAD) is a highly prevalent disorder with a high risk of mortality and amputation despite the introduction of novel medical and procedural treatments. Microvascular disease (MVD) is common among patients with PAD, and despite the established role as a predictor of amputations and mortality, MVD is not routinely assessed as part of current standard practice. Recent pre-clinical and clinical perfusion and molecular imaging studies have confirmed the important role of MVD in the pathogenesis and outcomes of PAD. The recent advancements in the imaging of the peripheral microcirculation could lead to a better understanding of the pathophysiology of PAD, and result in improved risk stratification, and our evaluation of response to therapies. In this review, we will discuss the current understanding of the anatomy and physiology of peripheral microcirculation, and the role of imaging for assessment of perfusion in PAD, and the latest advancements in molecular imaging. By highlighting the latest advancements in multi-modality imaging of the peripheral microcirculation, we aim to underscore the most promising imaging approaches and highlight potential research opportunities, with the goal of translating these approaches for improved and personalized management of PAD in the future.