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BACKGROUND: The use of guideline-directed medical therapy (GDMT) in patients undergoing peripheral vascular interventions (PVIs) decreases the risk of death and amputation and may decrease hospital readmissions. The variability of GDMT prescription across sites and operators and the proportionality of risk is not well understood. We aimed to study the association between variability of GDMT prescription at the site and operator level and outcomes (including 90-day readmissions and 24-month all-cause mortality and major amputation). METHODS: We examined GDMT discharge rates in PVIs performed between 2017 and 2018 using Medicare-linked Vascular Quality Initiative registry. GDMT included a statin, antiplatelet therapy, and angiotensin-converting enzyme inhibitor/angiotensin receptor blocker (ACE-i/ARB) if hypertensive. Quartiles (Q1-4) of GDMT rates were documented by operators and sites and variability was quantified using median odds ratios (MOR) and intraclass correlation (ICC). The association between lower GDMT rates (per 10%) by sites and operators with 90-day readmission were calculated using logistic regression, and with 24-month mortality and major amputation using parametric survival model. Models were adjusted for patient-level factors and included sites and operators nested within sites as 2 random effects. RESULTS: GDMT rates for 17,147 patients across 223 sites and 1,263 operators ranged from 0% to 38% (Q1, MOR 1.43, 95%CI 1.39-1.47, P ≤ .001) to 57%-100% (Q4, MOR 1.48, 95%CI 1.44-1.51, P ≤ .001). Four percent of variance in GDMT use was explained by sites (ICC 3.9, 95%CI 2.9-5.3) and operators (ICC 4.1, 95%CI 3.1-5.4). A dose-response relationship was noted between lower GDMT rates and increased risk of 90-day readmission risk by sites (P = .021) and operators (P < .001). Lower GDMT prescription by site was associated with higher risk of 24-month mortality (HR = 1.07, 95%CI 1.02-1.13) and major amputation (HR = 1.08, 95%CI 1.01-1.15). Similar associations were found for GDMT use by provider (mortality HR = 1.05, 95%CI 1.02-1.08 and amputation HR = 1.04, 95%CI 1.00-1.08). CONCLUSION: Both at the operator and health system level, there was significant variability in GDMT prescription following PVI, proportionally translating into risk for readmission, mortality, and major amputation. Targeted quality efforts should prioritize both operator and site levels to improve GDMT use and outcomes for patients undergoing PVI.
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Antagonistas de Receptores de Angiotensina , Insuficiência Cardíaca , Humanos , Idoso , Estados Unidos/epidemiologia , Estudos Retrospectivos , Inibidores da Enzima Conversora de Angiotensina , Medicare , Amputação Cirúrgica , Volume SistólicoRESUMO
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: As a key treatment goal for patients with symptomatic peripheral artery disease (PAD), improving health status has also become an important end point for clinical trials and performance-based care. An understanding of patient factors associated with 1-year PAD health status is lacking in patients with PAD. METHODS: The health status of 1073 consecutive patients with symptomatic PAD in the international multicenter PORTRAIT (Patient-Centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories) registry was measured at baseline and 1 year with the Peripheral Artery Questionnaire (PAQ). The association of 47 patient characteristics with 1-year PAQ scores was assessed using a random forest algorithm. Variables of clinical significance were retained and included in a hierarchical multivariable linear regression model predicting 1-year PAQ summary scores. RESULTS: The mean age of patients was 67.7 ± 9.3 years, and 37% were female. Variables with the highest importance ranking in predicting 1-year PAQ summary score were baseline PAQ summary score, Patient Health Questionnaire-8 depression score, Generalized Anxiety Disorder-2 anxiety score, new onset symptom presentation, insurance status, current or prior diagnosis of depression, low social support, initial invasive treatment, duration of symptoms, and race. The addition of 19 clinical variables in an extended model marginally improved the explained variance in 1-year health status (from R2 0.312 to 0.335). CONCLUSIONS: Patients' 1-year PAD-specific health status, as measured by the PAQ, can be predicted from 10 mostly psychosocial and socioeconomic patient characteristics including depression, anxiety, insurance status, social support, and symptoms. These characteristics should be validated and tested in other PAD cohorts so that this model can inform risk adjustment and prediction of PAD health status in comparative effectiveness research and performance-based care.
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Nível de Saúde , Claudicação Intermitente , Doença Arterial Periférica , Sistema de Registros , Determinantes Sociais da Saúde , Humanos , Feminino , Masculino , Idoso , Claudicação Intermitente/diagnóstico , Claudicação Intermitente/terapia , Claudicação Intermitente/psicologia , Claudicação Intermitente/epidemiologia , Doença Arterial Periférica/diagnóstico , Doença Arterial Periférica/terapia , Doença Arterial Periférica/psicologia , Doença Arterial Periférica/epidemiologia , Pessoa de Meia-Idade , Fatores de Tempo , Fatores de Risco , Inquéritos e Questionários , Saúde Mental , Fatores Socioeconômicos , Estudos ProspectivosRESUMO
OBJECTIVE: Comorbid chronic kidney disease (CKD) is associated with worse outcomes for patients with chronic limb-threatening ischemia (CLTI). However, comparative effectiveness data are limited for lower extremity bypass (LEB) vs peripheral vascular intervention (PVI) in patients with CLTI and CKD. We aimed to evaluate (1) 30-day all-cause mortality and amputation and (2) 5-year all-cause mortality and amputation for LEB vs PVI in patients with comorbid CKD. METHODS: Individuals who underwent LEB and PVI were queried from the Vascular Quality Initiative with Medicare claims-linked outcomes data. Propensity scores were calculated using 13 variables, and a 1:1 matching method was used. The mortality risk at 30 days and 5 years in LEB vs PVI by CKD was assessed using Kaplan-Meier and Cox proportional hazards models, with interaction terms added for CKD. For amputation, cumulative incidence functions and Fine-Gray models were used to account for the competing risk of death, with interaction terms for CKD added. RESULTS: Of 4084 patients (2042 per group), the mean age was 71.0 ± 10.8 years, and 69.0% were male. Irrespective of CKD status, 30-day mortality (hazard ratio [HR]: 0.94, 95% confidence interval [CI]: 0.63-1.42, P = .78) was similar for LEB vs PVI, but LEB was associated with a lower risk of 30-day amputation (sub-HR [sHR]: 0.66, 95% CI: 0.44-0.97, P = .04). CKD status, however, did not modify these results. Similarly, LEB vs PVI was associated with a lower risk of 5-year mortality (HR: 0.79, 95% CI: 0.71-0.88, P < .001) but no difference in 5-year amputation (sHR: 1.03, 95% CI: 0.89-1.20, P = .67). CKD status did not modify these results. CONCLUSIONS: Regardless of CKD status, patients had a lower risk of 5-year all-cause mortality and 30-day amputation with LEB vs PVI. Results may help inform preference-sensitive treatment decisions on LEB vs PVI for patients with CLTI and CKD, who may commonly be deemed too high risk for surgery.
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Amputação Cirúrgica , Isquemia Crônica Crítica de Membro , Comorbidade , Salvamento de Membro , Doença Arterial Periférica , Insuficiência Renal Crônica , Humanos , Amputação Cirúrgica/mortalidade , Amputação Cirúrgica/efeitos adversos , Masculino , Feminino , Idoso , Insuficiência Renal Crônica/mortalidade , Insuficiência Renal Crônica/complicações , Insuficiência Renal Crônica/diagnóstico , Fatores de Risco , Fatores de Tempo , Medição de Risco , Estados Unidos/epidemiologia , Doença Arterial Periférica/mortalidade , Doença Arterial Periférica/cirurgia , Doença Arterial Periférica/complicações , Doença Arterial Periférica/diagnóstico , Idoso de 80 Anos ou mais , Isquemia Crônica Crítica de Membro/cirurgia , Isquemia Crônica Crítica de Membro/mortalidade , Isquemia Crônica Crítica de Membro/complicações , Estudos Retrospectivos , Resultado do Tratamento , Pessoa de Meia-Idade , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/mortalidade , Extremidade Inferior/irrigação sanguínea , Enxerto Vascular/mortalidade , Enxerto Vascular/efeitos adversos , Bases de Dados Factuais , Medicare , Isquemia/mortalidade , Isquemia/cirurgia , Isquemia/diagnóstico , Procedimentos Cirúrgicos Vasculares/mortalidade , Procedimentos Cirúrgicos Vasculares/efeitos adversosRESUMO
OBJECTIVE: A critical goal in the care of patients with peripheral artery disease (PAD) is to optimize their health status; their symptoms, function, and quality of life. Social support has been proposed to be a predictor of disease-specific health status in 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 PORTRAIT registry, which enrolled patients with PAD in the United States, Netherlands, and Australia from 2011-2015, was used. Perceived social support was assessed at baseline with the ENRICHD Social Support Inventory (ESSI), while disease-specific (Peripheral Artery Disease Questionnaire [PAQ]) and generic health status (EuroQoL 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 ≤ 3 on 2 items and an ESSI score ≤ 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% females), 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<0.001), 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%CI -10.97; -3.07) point reduction in the PAQ, -7.43 (95%CI -10.33; -4.54) in the VAS, and -0.06 (95%CI -0.09; -0.03) in the EQ-5D-3L Index. Adjusting for biopsychosocial factors minimally attenuated these associations (PAQ: -6.52 95%CI -10.55; -2.49 p=0.002 , VAS: -5.39 95%CI 8.36; -2.42 p <0.001 , EQ-5D-3L Index -0.04 95%CI -0.07; 0.01 p=0.022). The ESSI per-point score was associated with a decrease of 0.51 (95%CI 0.18; 0.85; p=0.003) in PAQ and 0.46 (95%CI 0.12; 0.61; p=0.004) in the VAS. CONCLUSION: Among patients with PAD, low social support was frequent and associated with lower health status at 1 year independently of other biopsychosocial variables. Improving social support could improve health status and outcomes in PAD.
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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 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 was 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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INTRODUCTION: Patients with chronic limb-threatening ischemia (CLTI) have high mortality rates after revascularization. Risk stratification for short-term outcomes is challenging. We aimed to develop machine-learning models to rank predictive variables for 30-day and 90-day all-cause mortality after peripheral vascular intervention (PVI). METHODS: Patients undergoing PVI for CLTI in the Medicare-linked Vascular Quality Initiative were included. Sixty-six preprocedural variables were included. Random survival forest (RSF) models were constructed for 30-day and 90-day all-cause mortality in the training sample and evaluated in the testing sample. Predictive variables were ranked based on the frequency that they caused branch splitting nearest the root node by importance-weighted relative importance plots. Model performance was assessed by the Brier score, continuous ranked probability score, out-of-bag error rate, and Harrell's C-index. RESULTS: A total of 10,114 patients were included. The crude mortality rate was 4.4% at 30 days and 10.6% at 90 days. RSF models commonly identified stage 5 chronic kidney disease (CKD), dementia, congestive heart failure (CHF), age, urgent procedures, and need for assisted care as the most predictive variables. For both models, eight of the top 10 variables were either medical comorbidities or functional status variables. Models showed good discrimination (C-statistic 0.72 and 0.73) and calibration (Brier score 0.03 and 0.10). CONCLUSION: RSF models for 30-day and 90-day all-cause mortality commonly identified CKD, dementia, CHF, need for assisted care at home, urgent procedures, and age as the most predictive variables as critical factors in CLTI. Results may help guide individualized risk-benefit treatment conversations regarding PVI.
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Demência , Procedimentos Endovasculares , Falência Renal Crônica , Doença Arterial Periférica , Humanos , Idoso , Estados Unidos/epidemiologia , Isquemia Crônica Crítica de Membro , Fatores de Risco , Resultado do Tratamento , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/cirurgia , Procedimentos Endovasculares/métodos , Isquemia/diagnóstico por imagem , Isquemia/cirurgia , Salvamento de Membro/métodos , Medicare , Falência Renal Crônica/complicações , Demência/complicações , Estudos Retrospectivos , Doença CrônicaRESUMO
OBJECTIVES: Antiplatelet therapy is an essential element in the management of patients with arterial vascular disease. In peripheral arterial disease (PAD), dual antiplatelet therapy (DAPT), primarily clopidogrel and aspirin, is routinely prescribed following intervention. There is sparse data regarding the need for DAPT, the appropriate duration, or the heterogeneity of treatment effects for antiplatelet regimens across patients, leading to potential uncertainty and heterogeneity around treatment practices. An example of heterogeneity of treatment effects is a patients' metabolizer status for the use of clopidogrel. The aim of the study was to (1) assess clinicians' knowledge of and attitudes toward managing patients with CYP2C19 mutations, (2) identify barriers to implementation of CYP2C19 testing and management policies, and (3) reach consensus for CYP2C19 testing and management strategies for patients with PAD who undergo peripheral vascular interventions (PVI). METHODS: A modified Delphi method was used to establish consensus amongst PAD interventionalists around CYP2C19 testing. All practicing Yale New Haven Hospital PAD interventionalists with backgrounds in interventional cardiology, vascular surgery, or interventional radiology were approached by email for participation. Round 1 included the collection of baseline demographic questions, knowledge questions, and three statements for consensus. Knowledge questions were rated on a 0-10 Likert scale with the following anchors: 0 ("Not at all"), 5 ("Neutral), and 10 ("Very Much"). Participants were asked to rate the importance of the three consensus statements on a 9-point Likert scale from 1 ("Strongly Disagree") to 10 ("Strongly Agree"). In Round 2, participants were shown the same consensus statements, the median response of the group from the previous round, and their previous answers. Participants were instructed to revise their rating using the results from the previous round. This process was repeated for Round 3. RESULTS: Of the 28 experts invited to participate, 13 agreed (46%). Participants were predominantly male (92.3%) and white (61.5%) with representation from interventional cardiology (46.2%) and vascular surgery (53.8%). Most participants reported more than 10+ years in practice (61.5%). PAD interventionalists felt they would benefit from more education regarding CYP2C19 mutations (median score 8.0, interquartile range 5.0-8.5). They indicated some familiarity with CYP2C19 mutations (7.0, 6.0-9.5) but did not feel strongly that CYP2C19 was important to their practice (6.0, 5.5-7.5). In each round, the median responses for the three consensus statements were 5, 6, and 9, respectively. With each successive round the interquartile range narrowed indicative of evolving consensus but did not reach the prespecified interquartile range for consensus of 1 for any of the statements. CONCLUSIONS: PAD interventionalists practicing at an academic health system recognize the heterogenous response of their patients to clopidogrel therapy but are unsure when to leverage genetic testing to improve outcomes for their patients. Our study identified gaps regarding PAD interventionalists' knowledge, perceived barriers, and attitudes toward CYP2C19 testing in PAD. This information highlights the need for randomized data on genetic testing for clopidogrel responsiveness in peripheral vascular disease following intervention to help guide antiplatelet management.
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BACKGROUND: The VASCADE closure device deploys an extravascular collagen plug. Its use in those with access site disease undergoing peripheral vascular intervention (PVI) is unknown. We aimed to evaluate the efficacy and safety of the VASCADE closure device compared to manual compression (MC) in patients with moderate femoral access site disease. METHODS: We performed a single-center, retrospective review of patients undergoing PVI with at least moderate access site disease. Our institutional database was linked to the Vascular Quality Initiative database, and 200 patients were selected from a 1:1 propensity-matched cohort. Data on procedural metrics and outcomes up to 30-days were abstracted. RESULTS: There were 103 procedures that used VASCADE and 97 used MC. Baseline variables were similar between groups. The mean age was 68.2 ± 11.2 years and 37.6% were women. Closing mean activated clotting time (ACT) was shorter in VASCADE (198 s VASCADE vs. 213 s MC; p = 0.018). There was a nonsignificant decrease in external compression device use with VASCADE (VASCADE 19.0% vs. MC 28.1%; p = 0.15). At 30-days, there was a nonsignificant reduction in hematoma with VASCADE (3.8% vs. 7.8% MC; p = 0.25) and no difference in retroperitoneal bleeding (0.5%). Pseudoaneurysm rate was similar (1.3% VASCADE vs. 1.7% MC; p = 0.79). The 30-day mortality rate was similar between the two groups and not related to the procedure (1.3% VASCADE vs. 0.9% MC; p = 0.79). CONCLUSION: In patients undergoing PVI with at least moderate access site disease, safety and efficacy after using VASCADE was comparable with MC.
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Artéria Femoral , Dispositivos de Oclusão Vascular , Humanos , Feminino , Pessoa de Meia-Idade , Idoso , Masculino , Artéria Femoral/diagnóstico por imagem , Dispositivos de Oclusão Vascular/efeitos adversos , Técnicas Hemostáticas/efeitos adversos , Punções , Resultado do TratamentoRESUMO
BACKGROUND: Historically, persistent atrial fibrillation (PeAF) and long standing persistent atrial fibrillation (LSPeAF) have demonstrated limited clinical success despite hybrid approaches. OBJECTIVE: We describe our experience with the endocardial-before-epicardial approach defined by a comprehensive endovascular approach preceding and guiding the epicardial approach which includes an extensive posterior wall ablation. METHODS: 40 patients were followed over a 12 month period. The procedure was performed in a single center. Patients had a mean duration of atrial fibrillation of 6.0 ± 4.5 years with 22.5% having undergone prior ablations. Mean age was 61.7 ± 7.9 years with a mean left atrial volume of 131.5 ± 46.9 mL. The endovascular procedure remained uniform with antral pulmonary vein isolation, posterior left atrial roof and right atrial cavo-tricuspid isthmus (CTI) linear lesions with mapping and ablation of left atrial complex electrograms (CFAEs) and prior existing atrial arrhythmias. The epicardial procedure included a thorascopic approach with ganglionated plexus (GP) mapping and ablation, left atrial posterior wall ablation, directed CFAE ablation and left atrial appendage ligation. All patients received implantable cardiac monitoring. RESULTS: All 40 patients remained in sinus rhythm at their 12 month follow-up. During the monitoring period, episodes of paroxysmal atrial arrhythmias including fibrillation were documented, without persistence, after discontinuation of oral antiarrhythmic medications. CONCLUSION: The endo-before-epi approach resulted in improved management of persistent and long standing persistent atrial fibrillation over reported results for conventional approaches with no procedural complications, making this a promising option for the management of these arrhythmias.
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Antiarrítmicos/administração & dosagem , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/cirurgia , Ablação por Cateter/métodos , Eletrocardiografia , Idoso , Fibrilação Atrial/tratamento farmacológico , Ablação por Cateter/efeitos adversos , Doença Crônica , Estudos de Coortes , Feminino , Seguimentos , Humanos , Infusões Intravenosas , Masculino , Pessoa de Meia-Idade , Monitorização Fisiológica/métodos , Cuidados Pré-Operatórios/métodos , Estudos Prospectivos , Recidiva , Reoperação/métodos , Medição de Risco , Índice de Gravidade de Doença , Fatores de Tempo , Resultado do TratamentoRESUMO
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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Isquemia Crônica Crítica de Membro , Aprendizado de Máquina , Humanos , Masculino , Feminino , Idoso , Medição de Risco/métodos , Isquemia Crônica Crítica de Membro/mortalidade , Estados Unidos/epidemiologia , Fatores de Risco , Idoso de 80 Anos ou mais , Sistema de Registros , Fatores de Tempo , Pessoa de Meia-Idade , Doença Arterial Periférica/mortalidade , Doença Arterial Periférica/diagnóstico , Estudos RetrospectivosRESUMO
OBJECTIVE: Chronic venous disease is a common condition and has a significant impact on patients' health status. Validated patient-reported outcome measures (PROMs) used to assess health status are needed to measure health status. This state-of-the-art review summarizes the current validation evidence for disease-specific PROMs for chronic venous disease and provides a framework for their use in the clinical setting. METHODS: A literature search in OVID Embase and Medline was conducted to identify relevant English-language studies of chronic venous disease that used disease-specific PROMs between January 1, 1993, and June 30, 2022. Abstracts and titles from identified studies were screened by four investigators, and full-text articles were subsequently screened for eligibility. Data on validation of disease-specific PROMs was abstracted from each included article. Classical test theory was used as a framework to examine a priori defined validation criteria for content validity, reliability (construct validity, internal reliability, and test-retest reliability), responsiveness, and expansion of the validation evidence base (use in randomized controlled trials and comparative effectiveness research, cultural or linguistic translations, predictive validity, or establishing the minimal clinically important difference threshold, defined as smallest amount an outcome or measure is perceived as a meaningful change to patients). The PROMs were categorized into three groups based on the manifestations of disease of the population for which they were developed. The overall validity of each PROM was assessed across three stages of validation including content validity (phase 1); construct validity, reliability, and responsiveness (phase 2); and expansion of the validation evidence base (phase 3). RESULTS: Of 2338 unique studies screened, 112 studies (4.8%) met inclusion criteria. The eight disease-specific PROMs identified were categorized into three groups: (1) overall chronic venous disease (C1 to C6); (2) C1 to C4 disease; and (3) C5 to C6 disease. Assessed by group, the Chronic Venous Insufficiency Questionnaire met criteria for validation at all three phases for patients with C1 to C4 disease, and the Charing Cross Venous Ulcer Questionnaire met criteria for validation at all three phases for patients with C5 to C6 disease. There were no PROMs that met all criteria for validation for use in overall chronic venous disease (C1 to C6). CONCLUSIONS: Of the eight PROMs assessed in this review, only two met prespecified criteria at each phase for validation. The Chronic Venous Insufficiency Questionnaire and Charing Cross Venous Ulcer Questionnaire should be considered for use in patients with chronic venous disease without venous ulcers and with venous ulcers, respectively.
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Medidas de Resultados Relatados pelo Paciente , Qualidade de Vida , Humanos , Reprodutibilidade dos Testes , Doença Crônica , Nível de Saúde , Doenças Vasculares/diagnóstico , Doenças Vasculares/terapia , Doenças Vasculares/psicologia , Valor Preditivo dos TestesRESUMO
BACKGROUND: Peripheral artery disease (PAD) and microvascular disease (MVD) are highly prevalent conditions that share common risk factors. This observational study aimed to characterize patients with both conditions and determine the impact of comorbid PAD/MVD on outcomes. METHODS AND RESULTS: Patients admitted across 31 states January 2011 through December 2018 with a primary or secondary diagnosis of PAD or MVD were included from the National Readmissions Database and weighted to approximate a national sample. Those age <18 years or with nonatherosclerotic leg injuries were excluded. Patients were divided into 3 groups: PAD-only, MVD-only, or comorbid PAD/MVD. Multiple logistic regression was used to evaluate associations with major and minor amputations, major adverse cardiac events, and in-hospital mortality. Cox regression was used to evaluate associations with readmission within 1 year. The PAD group was used as reference. The final cohort included 33 972 772 admissions: 9.1 million with PAD, 21.3 million with MVD, and 3.6 million with both. Annual admissions for PAD/MVD increased to >500 000 in 2018. Major and minor amputations increased ≈50% for PAD/MVD between 2011 and 2018. Compared with PAD-only, PAD/MVD was associated with a higher risk for major amputation (odds ratio [OR], 1.30 [95% CI, 1.28-1.32]), minor amputation (OR, 2.15 [95% CI, 2.12-2.18]), major adverse cardiac events (OR, 1.04 [95% CI, 1.03-1.04]), in-hospital mortality (OR, 1.07 [95% CI, 1.05-1.09]), and readmission (hazard ratio, 1.02 [95% CI, 1.02-1.02]) after adjustment for baseline factors. CONCLUSIONS: Comorbid MVD is present in a large and growing number of patients with PAD and is associated with augmented risk for adverse outcomes. Further prospective research is merited to understand this vulnerable population.
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Doença Arterial Periférica , Humanos , Doença Arterial Periférica/diagnóstico , Doença Arterial Periférica/epidemiologia , Doença Arterial Periférica/cirurgia , Modelos de Riscos Proporcionais , Fatores de Risco , Resultado do Tratamento , AdultoRESUMO
Chronic cough is a common condition; until recently, no International Classification of Diseases (ICD) code for chronic cough existed; therefore, the true scope and burden of chronic cough is unclear. Using established algorithms, we examined chronic cough patients and their risk profiles, recurrent cough episodes, and subsequent 1-year health care utilization in the nationwide Cerner EHR data resource, compared with those with acute cough. An ICD-based algorithm was applied to the Cerner Health Facts EHR database to derive a phenotype of chronic cough defined as three ICD-based "cough" encounters 14-days apart over a 56-to-120-day period from 2015 to 2017. Demographics, comorbidities, and outcomes (1-year outpatient, emergency, and inpatient encounters) were collected for the chronic cough cohort and acute cough cohort. The chronic cough cohort was 61.5% female, 70.4% white, and 15.2% African American, with 13.7% being of Asian, Native American, or unknown race. Compared with the acute cough cohort, chronic cough patients were more likely to be older, female, and have chronic pulmonary disease, obesity, and depression. Predictors of recurrent chronic cough were older age and race. Those with chronic cough had more outpatient (2.48 ± 2.10 vs. 1.48 ± 0.99; SMD = 0.94), emergency (1.90 ± 2.26 vs. 1.23 ± 0.68; SMD = 0.82), and inpatient (1.11 ± 0.36 vs. 1.05 ± 0.24, SMD = 0.24) encounters compared with acute cough. While EHR-based data may provide a useful resource to identify chronic cough phenotypes, supplementary data approaches and screening methods for chronic cough can further identify the scope of the problem.
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BACKGROUND: National quality reporting efforts after revascularization for peripheral artery disease (PAD) are ongoing. Validation of endpoints are necessary in national quality registries. OBJECTIVES: This study sought to examine the interrater reliability for the endpoint of major amputation at 1 year in the Vascular Quality Initiative (VQI) registry and the Medicare-linked Vascular Quality Initiative registry (VQI-VISION) against electronic health record (EHR) review. METHODS: Surgical or endovascular revascularization procedures between January 1, 2010, and December 31, 2017, in the VQI registry and VQI-VISION for 2 academic health systems were queried. Major amputation data were abstracted by trained data collectors for the VQI and derived from Current Procedural Terminology codes for VQI-VISION. Cases underwent protocolized adjudication for the endpoint of major amputation by EHR review. Paired tests were used to evaluate the sensitivity and specificity. Spearman's ρ and Cohen's κ were used to evaluate interrater reliability. RESULTS: Amputation endpoints for 1,936 revascularizations were examined. Compared with major amputation data in EHR review, the sensitivity for the VQI registry was 35.9% and the specificity was 99.4% (ρ = 0.53; κ = 0.48). For VQI-VISION, sensitivity was 67.7% and specificity was 98.9% (ρ = 0.75; κ = 0.74). For any amputation in VQI data, sensitivity was 35.3% and specificity was 99.3% (ρ = 0.53; κ = 0.46), and for VQI-VISION, they were 71.6% and 97.7%, respectively (ρ = 0.75; κ = 0.74). CONCLUSIONS: Almost two-thirds of the amputations in the VQI registry and one-third of amputations in VQI-VISION were missing at 1 year compared against adjudicated EHR review. In preparing for national reporting systems for major amputation tracking, data collection system reform is needed.
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Procedimentos Endovasculares , Doença Arterial Periférica , Idoso , Humanos , Estados Unidos , Resultado do Tratamento , Reprodutibilidade dos Testes , Fatores de Risco , Complicações Pós-Operatórias/cirurgia , Medicare , Procedimentos Cirúrgicos Vasculares/efeitos adversos , Procedimentos Endovasculares/efeitos adversos , Doença Arterial Periférica/diagnóstico , Doença Arterial Periférica/cirurgia , Amputação Cirúrgica , Estudos RetrospectivosRESUMO
Obesity has been associated with poor disease outcomes in patients with lower extremity peripheral arterial disease (PAD). Given evolving treatments for obesity, evaluating its prevalence and treatment practices are key to develop a holistic management of PAD. We aimed to examine prevalence of obesity and variability of management strategies in symptomatic PAD patients enrolled in the international multicenter PORTRAIT registry from 2011 to 2015. Obesity management strategies studied included weight and/or dietary counseling and prescription of weight loss medications (orlistat, lorcaserin, phentermine-topiramate, naltrexone-buproprion, and liraglutide). Use frequency of obesity management strategies were calculated by country and compared across centers using adjusted median odds ratios (MOR). Of 1002 patients included, 36 % had obesity. No patients received weight loss medications. Weight and/or dietary counseling was prescribed in only 20 % of patients with obesity with significant variability in practices between centers (range 0.0-39.7 %; MOR 3.6, 95 % CI 2.04-9.95, p = < 0.001). In conclusion, obesity is a prevalent modifiable comorbidity in PAD that is hardly addressed during PAD management, with significant variability across practices. As obesity prevalence rates are growing, along with treatment modalities to treat it, especially in those with PAD, building systems to integrate systematic evidence-based weight and dietary management strategies in PAD are essential to close this gap in care.
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Fármacos Antiobesidade , Doença Arterial Periférica , Humanos , Prevalência , Redução de Peso , Topiramato/uso terapêutico , Obesidade/complicações , Obesidade/epidemiologia , Obesidade/terapia , Fármacos Antiobesidade/uso terapêutico , Doença Arterial Periférica/complicações , Doença Arterial Periférica/epidemiologia , Doença Arterial Periférica/terapiaRESUMO
BACKGROUND: Lack of guideline-directed medical therapy (GDMT) in patients undergoing peripheral vascular interventions (PVIs) may increase mortality and amputation risk. OBJECTIVES: The authors sought to study the association between GDMT and mortality/amputation and to examine GDMT variability among providers and health systems. METHODS: We performed an observational study using patients in the Vascular Quality Initiative registry undergoing PVI between 2017 and 2018. Two-year all-cause mortality and major amputation data were derived from Medicare claims data. Compliance with GDMT was defined as receiving a statin, antiplatelet therapy, and angiotensin-converting enzyme inhibitor/angiotensin receptor blocker if hypertensive. Propensity 1:1 matching was applied for GDMT vs no GDMT and survival analyses were performed to compare outcomes between groups. RESULTS: Of 15,891 patients undergoing PVIs, 48.8% received GDMT and 6,120 patients in each group were matched. Median follow-up was 9.6 (IQR: 4.5-16.2) months for mortality and 8.4 (IQR: 3.5-15.4) for amputation. Mean age was 72.0 ± 9.9 years. Mortality risk was higher among patients who did not receive GDMT versus those on GDMT (31.2% vs 24.5%; HR: 1.37, 95% CI: 1.25-1.50; P < 0.001), as well as, risk of amputation (16.0% vs 13.2%; HR: 1.20; 95% CI: 1.08-1.35; P < 0.001). GDMT rates across sites and providers ranging from 0% to 100%, with lower performance translating into higher risk. CONCLUSIONS: Almost one-half of the patients receiving PVI in this national quality registry were not on GDMT, and this was associated with increased risk of mortality and major amputation. Quality improvement efforts in vascular care should focus on GDMT in patients undergoing PVI.
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Insuficiência Cardíaca , Humanos , Idoso , Estados Unidos , Pessoa de Meia-Idade , Idoso de 80 Anos ou mais , Resultado do Tratamento , Medicare , Inibidores da Enzima Conversora de Angiotensina , Amputação Cirúrgica , Volume SistólicoRESUMO
While nutritional interventions are first-line therapy for many chronic diseases, most medical trainees receive minimal nutrition education, leaving them unprepared to address nutritional issues with patients. An interactive, single-session, virtual nutrition curriculum was taught online to 80 physician assistant (PA) students. Topics included plant-based nutrition, dietary history-taking and counseling, and culinary medicine. Students were surveyed before, immediately after, and four weeks after the curriculum to assess changes to nutrition-related knowledge, attitudes, confidence, and personal dietary behaviors. Seventy-three PA students (91%) completed the pre-survey, 76 (95%) completed the post-survey, and 42 (52.5%) completed the delayed post-survey. Knowledge scores increased immediately post-intervention (48.9% to 78.9%; p < 0.001) and persisted four weeks later (78.9% to 75.8%; p = 0.54). Post-intervention, students felt more confident in dietary history-taking (55% vs. 95%; p = 0.001) and nutrition counseling (53% vs. 84%; p = 0.003) and agreed that dietary changes alone could reverse type 2 diabetes (74% vs. 97%; p = 0.027) and coronary artery disease (66% vs. 92%; p = 0.039). Curricula using virtual teaching kitchens may be a scalable approach to nutrition education for medical trainees.
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Diabetes Mellitus Tipo 2 , Estudantes de Medicina , Humanos , Estudantes de Medicina/psicologia , Educação em Saúde , Dieta , Aconselhamento , CurrículoRESUMO
BACKGROUND: Peripheral artery disease (PAD) is highly prevalent and associated with poor outcomes. Depression is a risk factor for adverse outcomes in patients with coronary artery disease. Despite evidence showing that depression is common in patients with PAD, less is known about its association with adverse prognostic outcomes. To address this, we conducted a systematic review and meta-analysis to summarize the association between depression and outcomes in patients with PAD. METHODS: We performed a systematic search of eight databases to January 2022 including studies that reported a risk estimate for the association of depression or depressive symptoms with all-cause mortality or major adverse limb events (MALE) in patients with PAD and pooled results in a meta-analysis. Risk of bias was assessed using ROBINS-I. RESULTS: Of the 7048 articles screened, 5 observational studies with 119,123 patients were included. A total of 16.2 % had depression or depressive symptoms. Depression was associated with a statistically significant increased risk of all-cause mortality (HR 1.24, confidence interval 1.07-1.25, p = .005). The association between depression and MALE was not significant but trended toward a positive association. LIMITATIONS: Due to lack of data, results were limited by a single study with a large sample size, overrepresentation of men, and lack of information of depression severity or treatment status. CONCLUSION: Depression or depressive symptoms are associated with a 24 % increased risk of all-cause mortality in patients with PAD. Future work should explore the mechanisms and directionality of this association and identify depression as an important comorbidity to address for patients with PAD. REGISTRATION: PROSPERO CRD 42021223694.