RESUMO
OBJECTIVE: Sustained clinical and hemodynamic benefit after revascularization for chronic limb-threatening ischemia (CLTI) is needed to resolve symptoms and prevent limb loss. We sought to compare rates of clinical and hemodynamic failure as well as resolution of initial and prevention of recurrent CLTI after endovascular (ENDO) vs bypass (OPEN) revascularization in the Best-Endovascular-versus-best-Surgical-Therapy-in-patients-with-CLTI (BEST-CLI) trial. METHODS: As planned secondary analyses of the BEST-CLI trial, we examined the rates of (1) clinical failure (a composite of all-cause death, above-ankle amputation, major reintervention, and degradation of WIfI stage); (2) hemodynamic failure (a composite of above-ankle amputation, major and minor reintervention to maintain index limb patency, failure to an initial increase or a subsequent decrease in ankle brachial index of 0.15 or toe brachial index of 0.10, and radiographic evidence of treatment stenosis or occlusion); (3) time to resolution of presenting CLTI symptoms; and (4) incidence of recurrent CLTI. Time-to-event analyses were performed by intention-to-treat assignment in both trial cohorts (cohort 1: suitable single segment great saphenous vein [SSGSV], N = 1434; cohort 2: lacking suitable SSGSV, N = 396), and multivariate stratified Cox regression models were created. RESULTS: In cohort 1, there was a significant difference in time to clinical failure (log-rank P < .001), hemodynamic failure (log-rank P < .001), and resolution of presenting symptoms (log-rank P = .009) in favor of OPEN. In cohort 2, there was a significantly lower rate of hemodynamic failure (log-rank P = .006) favoring OPEN, and no significant difference in time to clinical failure or resolution of presenting symptoms. Multivariate analysis revealed that assignment to OPEN was associated with a significantly lower risk of clinical and hemodynamic failure in both cohorts and a significantly higher likelihood of resolving initial and preventing recurrent CLTI symptoms in cohort 1, including after adjustment for key baseline patient covariates (end-stage renal disease [ESRD], prior revascularization, smoking, diabetes, age >80 years, WIfI stage, tissue loss, and infrapopliteal disease). Factors independently associated with clinical failure included age >80 years in cohort 1 and ESRD across both cohorts. ESRD was associated with hemodynamic failure in cohort 1. Factors associated with slower resolution of presenting symptoms included diabetes in cohort 1 and WIfI stage in cohort 2. CONCLUSIONS: Durable clinical and hemodynamic benefit after revascularization for CLTI is important to avoid persistent and recurrent CLTI, reinterventions, and limb loss. When compared with ENDO, initial treatment with OPEN surgical bypass, particularly with available saphenous vein, is associated with improved clinical and hemodynamic outcomes and enhanced resolution of CLTI symptoms.
RESUMO
AIM: The "2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS/SIR/VESS Guideline for the Management of Lower Extremity Peripheral Artery Disease" provides recommendations to guide clinicians in the treatment of patients with lower extremity peripheral artery disease across its multiple clinical presentation subsets (ie, asymptomatic, chronic symptomatic, chronic limb-threatening ischemia, and acute limb ischemia). METHODS: A comprehensive literature search was conducted from October 2020 to June 2022, encompassing studies, reviews, and other evidence conducted on human subjects that was published in English from PubMed, EMBASE, the Cochrane Library, CINHL Complete, and other selected databases relevant to this guideline. Additional relevant studies, published through May 2023 during the peer review process, were also considered by the writing committee and added to the evidence tables where appropriate. STRUCTURE: Recommendations from the "2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity Peripheral Artery Disease" have been updated with new evidence to guide clinicians. In addition, new recommendations addressing comprehensive care for patients with peripheral artery disease have been developed.
Assuntos
American Heart Association , Extremidade Inferior , Doença Arterial Periférica , Humanos , Doença Arterial Periférica/terapia , Doença Arterial Periférica/diagnóstico , Extremidade Inferior/irrigação sanguínea , Estados Unidos , Cardiologia/normasRESUMO
AIM: The "2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS/SIR/VESS Guideline for the Management of Lower Extremity Peripheral Artery Disease" provides recommendations to guide clinicians in the treatment of patients with lower extremity peripheral artery disease across its multiple clinical presentation subsets (ie, asymptomatic, chronic symptomatic, chronic limb-threatening ischemia, and acute limb ischemia). METHODS: A comprehensive literature search was conducted from October 2020 to June 2022, encompassing studies, reviews, and other evidence conducted on human subjects that was published in English from PubMed, EMBASE, the Cochrane Library, CINHL Complete, and other selected databases relevant to this guideline. Additional relevant studies, published through May 2023 during the peer review process, were also considered by the writing committee and added to the evidence tables where appropriate. STRUCTURE: Recommendations from the "2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity Peripheral Artery Disease" have been updated with new evidence to guide clinicians. In addition, new recommendations addressing comprehensive care for patients with peripheral artery disease have been developed.
Assuntos
American Heart Association , Extremidade Inferior , Doença Arterial Periférica , Humanos , Doença Arterial Periférica/terapia , Doença Arterial Periférica/diagnóstico , Extremidade Inferior/irrigação sanguínea , Estados Unidos , Cardiologia/normas , Sociedades Médicas/normasRESUMO
BACKGROUND: There is a paucity of real-world data on the in-hospital (IH) and post-discharge outcomes in patients undergoing lower extremity peripheral vascular intervention (PVI) with adjunctive atherectomy. AIMS: In this retrospective, registry-based study, we evaluated IH and post-discharge outcomes among patients undergoing PVI, treated with or without atherectomy, in the National Cardiovascular Data Registry PVI Registry. METHODS: The IH composite endpoint included procedural complications, bleeding or thrombosis. The primary out-of-hospital endpoint was major amputation at 1 year. Secondary endpoints included repeat endovascular or surgical revascularisation and death. Multivariable regression was used to identify predictors of atherectomy use and its association with clinical endpoints. RESULTS: A total of 30,847 patients underwent PVI from 2014 to 2019, including 10,971 (35.6%) treated with atherectomy. The unadjusted rate of the IH endpoint occurred in 524 (4.8%) of the procedures involving atherectomy and 1,041 (5.3%) of non-atherectomy procedures (p=0.07). After adjustment, the use of atherectomy was not associated with an increased risk of the combined IH endpoint (p=0.68). In the 6,889 (22.4%) patients with out-of-hospital data, atherectomy was associated with a reduced risk of amputation (adjusted hazard ratio [aHR] 0.67, 95% confidence interval [CI]: 0.51-0.85; p<0.01) and surgical revascularisation (aHR 0.63, 95% CI: 0.44-0.89; p=0.017), no difference in death rates (p=0.10), but an increased risk of endovascular revascularisation (aHR 1.21, 95% CI: 1.06-1.39; p<0.01) at 1 year. CONCLUSIONS: The use of atherectomy during PVI is common and is not associated with an increase in IH adverse events. Longitudinally, patients treated with atherectomy undergo repeat endovascular reintervention more frequently but experience a reduced risk of amputation and surgical revascularisation.
Assuntos
Procedimentos Endovasculares , Doença Arterial Periférica , Humanos , Estudos Retrospectivos , Assistência ao Convalescente , Procedimentos Endovasculares/efeitos adversos , Fatores de Risco , Resultado do Tratamento , Alta do Paciente , Aterectomia/efeitos adversos , Aterectomia/métodos , Extremidade Inferior/irrigação sanguínea , Extremidade Inferior/cirurgiaRESUMO
Objectives: This report describes the use of an Everolimus-eluting stent (Xience Skypoint stent) for the treatment of medically-refractory ICAD. Design: Retrospective, case-series. Setting: In-hospital patients. Participants: All patients in this report had a history of stroke secondary to ICAD. All patients failed aggressive medical treatments and had recurrence of symptoms despite anticoagulation or dual-antiplatelet therapy plus a statin. Diagnostic angiogram in each case showed severe vessel stenosis, therefore patients were recommended for intracranial artery stenting. Main outcome measures: Technical feasibility of deploying Xience Skypoint stent for treatmet of ICAD. Results: The Xience Skypoint stent was safely and effectively deployed in the vertebral artery (x1) and the internal carotid artery (x2) using trans-ulnar (x1), trans-radial (x1), and trans-femoral (x1) approaches without the use of an intermediate catheter. Conclusion: Second-generation EES such as Xience Skypoint may be utilized for treatment of medically-refractory ICAD. This technical report serves as a proof of concept for further studies analysing long-term safety and efficacy of such stents for treatment of ICAD.
RESUMO
AIM: The "2022 ACC/AHA Guideline for the Diagnosis and Management of Aortic Disease" provides recommendations to guide clinicians in the diagnosis, genetic evaluation and family screening, medical therapy, endovascular and surgical treatment, and long-term surveillance of patients with aortic disease across its multiple clinical presentation subsets (ie, asymptomatic, stable symptomatic, and acute aortic syndromes). METHODS: A comprehensive literature search was conducted from January 2021 to April 2021, encompassing studies, reviews, and other evidence conducted on human subjects that were published in English from PubMed, EMBASE, the Cochrane Library, CINHL Complete, and other selected databases relevant to this guideline. Additional relevant studies, published through June 2022 during the guideline writing process, were also considered by the writing committee, where appropriate. STRUCTURE: Recommendations from previously published AHA/ACC guidelines on thoracic aortic disease, peripheral artery disease, and bicuspid aortic valve disease have been updated with new evidence to guide clinicians. In addition, new recommendations addressing comprehensive care for patients with aortic disease have been developed. There is added emphasis on the role of shared decision making, especially in the management of patients with aortic disease both before and during pregnancy. The is also an increased emphasis on the importance of institutional interventional volume and multidisciplinary aortic team expertise in the care of patients with aortic disease.
Assuntos
Doenças da Aorta , Doença da Válvula Aórtica Bicúspide , Cardiologia , Feminino , Gravidez , Estados Unidos , Humanos , American Heart Association , Doenças da Aorta/diagnóstico , Doenças da Aorta/terapia , AortaRESUMO
BACKGROUND: Patients with chronic limb-threatening ischemia (CLTI) require revascularization to improve limb perfusion and thereby limit the risk of amputation. It is uncertain whether an initial strategy of endovascular therapy or surgical revascularization for CLTI is superior for improving limb outcomes. METHODS: In this international, randomized trial, we enrolled 1830 patients with CLTI and infrainguinal peripheral artery disease in two parallel-cohort trials. Patients who had a single segment of great saphenous vein that could be used for surgery were assigned to cohort 1. Patients who needed an alternative bypass conduit were assigned to cohort 2. The primary outcome was a composite of a major adverse limb event - which was defined as amputation above the ankle or a major limb reintervention (a new bypass graft or graft revision, thrombectomy, or thrombolysis) - or death from any cause. RESULTS: In cohort 1, after a median follow-up of 2.7 years, a primary-outcome event occurred in 302 of 709 patients (42.6%) in the surgical group and in 408 of 711 patients (57.4%) in the endovascular group (hazard ratio, 0.68; 95% confidence interval [CI], 0.59 to 0.79; P<0.001). In cohort 2, a primary-outcome event occurred in 83 of 194 patients (42.8%) in the surgical group and in 95 of 199 patients (47.7%) in the endovascular group (hazard ratio, 0.79; 95% CI, 0.58 to 1.06; P = 0.12) after a median follow-up of 1.6 years. The incidence of adverse events was similar in the two groups in the two cohorts. CONCLUSIONS: Among patients with CLTI who had an adequate great saphenous vein for surgical revascularization (cohort 1), the incidence of a major adverse limb event or death was significantly lower in the surgical group than in the endovascular group. Among the patients who lacked an adequate saphenous vein conduit (cohort 2), the outcomes in the two groups were similar. (Funded by the National Heart, Lung, and Blood Institute; BEST-CLI ClinicalTrials.gov number, NCT02060630.).
Assuntos
Isquemia Crônica Crítica de Membro , Salvamento de Membro , Procedimentos Cirúrgicos Vasculares , Humanos , Isquemia Crônica Crítica de Membro/cirurgia , Isquemia Crônica Crítica de Membro/terapia , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/métodos , Salvamento de Membro/efeitos adversos , Salvamento de Membro/métodos , Estudos Retrospectivos , Fatores de Risco , Resultado do Tratamento , Procedimentos Cirúrgicos Vasculares/efeitos adversos , Procedimentos Cirúrgicos Vasculares/métodos , Veia Safena/transplanteRESUMO
BACKGROUND: Intravascular ultrasound (IVUS) has been shown in limited prospective studies to improve procedural outcomes for patients undergoing lower extremity peripheral arterial intervention (PVI). OBJECTIVES: The authors aimed to study temporal trends, practice variation, and associated outcomes with the use of IVUS during PVI among Medicare beneficiaries. METHODS: All PVIs performed from 2016 to 2019 among Medicare beneficiaries aged >65 years were included. Temporal trends in IVUS use were stratified by procedural location (inpatient, outpatient, or ambulatory surgery center [ASC]/office-based laboratory [OBL]) and physician specialty. The primary outcome was major adverse limb events (MALE). Inverse probability weighting was used to account for differences in baseline characteristics. Cox regression with competing risks was used to estimate weighted hazard ratios. RESULTS: During the study period, 543,488 PVIs were included, of which 63,372 (11.7%) used IVUS. A substantial growth in IVUS use was observed, which was driven by procedures performed in ASCs/OBLs (23.6% increase from quarter 1 of 2016 through quarter 4 of 2019). Among operators who used IVUS, there was also notable variation in use (median operator use 5.4% of cases; IQR: 2.2%-15.0%; range, <1%-100%). In weighted analysis, IVUS use during PVI was associated with a lower risk of MALE through a median of 514 days (adjusted hazard ratio: 0.73; 95% CI: 0.70-0.75; P < 0.0001). CONCLUSIONS: In contemporary nationwide data, IVUS use during PVI has increased since 2016, driven by growth in the ASC/OBL setting. However, there remains substantial variation in operator practice. When used during PVI, IVUS was associated with a lower risk of short- and long-term MALE.
Assuntos
Procedimentos Endovasculares , Doença Arterial Periférica , Humanos , Estados Unidos , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/terapia , Doença Arterial Periférica/etiologia , Medicare , Procedimentos Endovasculares/efeitos adversos , Estudos Prospectivos , Resultado do Tratamento , Ultrassonografia de IntervençãoRESUMO
BACKGROUND: There has been growing use of intravascular ultrasound (IVUS) during lower extremity arterial and venous revascularization. Observational data suggest that the use of IVUS can improve periprocedural and long-term outcomes, but largescale prospective data remain limited. Consensus opinion regarding the appropriate use of IVUS during peripheral intervention is needed. OBJECTIVES: The purpose of this consensus document is to provide guidance on the appropriate use of IVUS in various phases of peripheral arterial and venous interventions. METHODS: A 12-member writing committee was convened to derive consensus regarding the appropriate clinical scenarios for use of peripheral IVUS. The group iteratively created a 72-question survey representing 12 lower extremity arterial interventional scenarios. Separately, a 40-question survey representing 8 iliofemoral venous interventional scenarios was constructed. Clinical scenarios were categorized by interventional phases: preintervention, intraprocedure, and postintervention optimization. Thirty international vascular experts (15 for each survey) anonymously completed the survey instrument. Results were categorized by appropriateness using the median value and disseminated to the voting panel to reevaluate for any disagreement. RESULTS: Consensus opinion concluded that IVUS use may be appropriate during the preintervention phase for evaluating the etiology of vessel occlusion and plaque morphology in the iliac and femoropopliteal arteries. IVUS was otherwise rated as appropriate during iliac and femoropopliteal revascularization in most other preintervention scenarios, as well as intraprocedural and postprocedural optimization phases. IVUS was rated appropriate in all interventional phases for the tibial arteries. For iliofemoral venous interventions, IVUS was rated as appropriate in all interventional phases. CONCLUSIONS: Expert consensus can help define clinical procedural scenarios in which peripheral IVUS may have value during lower extremity arterial and venous intervention while additional prospective data are collected.
Assuntos
Procedimentos Endovasculares , Extremidade Inferior , Ultrassonografia de Intervenção , Consenso , Artéria Femoral/diagnóstico por imagem , Humanos , Extremidade Inferior/irrigação sanguínea , Extremidade Inferior/diagnóstico por imagem , Estudos Prospectivos , Resultado do Tratamento , Ultrassonografia de Intervenção/métodosRESUMO
PURPOSE: To evaluate temporal trends, practice variation, and associated outcomes with the use of intravascular ultrasound (US) during deep venous stent placement among Medicare beneficiaries. MATERIALS AND METHODS: All lower extremity deep venous stent placement procedures performed between January 1, 2017, and December 31, 2019 among Medicare beneficiaries were included. Temporal trends in intravascular US use were stratified by procedural setting and physician specialty. The primary outcome was a composite of 12-month all-cause mortality, all-cause hospitalization, or repeat target vessel intervention. The secondary outcome was a composite of 12-month stent thrombosis, embolization, or restenosis. RESULTS: Among the 20,984 deep venous interventions performed during the study period, 15,184 (72.4%) utilized intravascular US. Moderate growth in intravascular US use was observed during the study period in all clinical settings. There was a variation in the use of intravascular US among all operators (median, 77.3% of cases; interquartile range, 20.0%-99.2%). In weighted analyses, intravascular US use during deep venous stent placement was associated with a lower risk of both the primary (adjusted hazard ratio, 0.72; 95% confidence interval [CI], 0.69-0.76; P < .001) and secondary (adjusted hazard ratio, 0.32; 95% CI, 0.27-0.39; P < .001) composite end points. CONCLUSIONS: Intravascular US is frequently used during deep venous stent placement among Medicare beneficiaries, with further increase in use from 2017 to 2019. The utilization of intravascular US as part of a procedural strategy was associated with a lower cumulative incidence of adverse outcomes after the procedure, including venous stent thrombosis and embolization.
Assuntos
Trombose , Ultrassonografia de Intervenção , Idoso , Estados Unidos , Humanos , Resultado do Tratamento , Medicare , Stents , Angiografia CoronáriaRESUMO
Background We aimed to characterize the occurrence of major adverse cardiovascular and limb events (MACE and MALE) among patients with peripheral artery disease (PAD) undergoing peripheral vascular intervention (PVI), as well as associated factors in patients with chronic limb threatening ischemia (CLTI). Methods and Results Patients undergoing PVI in the American College of Cardiology's (ACC) National Cardiovascular Data Registry's PVI Registry who could be linked to Centers for Medicare and Medicaid Services data were included. The primary outcomes were MACE, MALE, and readmission within 1 month and 1 year following index CLTI-PVI or non-CLTI-PVI. Cox proportional hazards regression was used to identify factors associated with the development of the primary outcomes among patients undergoing CLTI-PVI. There were 1758 (49.7%) patients undergoing CLTI-PVI and 1779 (50.3%) undergoing non-CLTI-PVI. By 1 year, MACE occurred in 29.5% of patients with CLTI (n=519), and MALE occurred in 34.0% of patients with CLTI (n=598). By 1 year, MACE occurred in 8.2% of patients with non-CLTI (n=146), and MALE occurred in 26.1% of patients with non-CLTI (n=465). Predictors of MACE at 1 year in CLTI-PVI included end-stage renal disease on hemodialysis, congestive heart failure, prior CABG, and severe lung disease. Predictors of MALE at 1 year in CLTI-PVI included treatment of a prior bypass graft, profunda femoral artery treatment, end-stage renal disease on hemodialysis, and treatment of a previously treated lesion. Conclusions Patients ≥65 years old undergoing PVI experience high rates of MACE and MALE. A range of modifiable and non-modifiable patient factors, procedural characteristics, and medications are associated with the occurrence of MACE and MALE following CLTI-PVI.
RESUMO
This review details the utility of intravascular ultrasound (IVUS) for the management of peripheral artery and venous disease. The purpose of this document is to provide an update in the use of IVUS in peripheral arterial and venous pathology and demonstrate the use of IVUS as a practical diagnostic imaging procedure to evaluate and treat peripheral vascular disorders. IVUS, a diagnostic tool that relies on sound waves to produce precise images of the vessel being evaluated, was originally introduced to the medical community for the purposes of peripheral artery imaging, though it was quickly adapted for coronary interventions with positive outcomes. The utility of IVUS includes vessel measurement, pre- and post-procedural planning, treatment optimisation, and detection of thrombus, dissection or calcium severity. While angiography remains the standard imaging approach during peripheral intervention, multiple observational studies and small prospective trials have shown that in comparison, IVUS provides more accurate imaging detail, which may improve procedural outcomes. IVUS can also address limitations of angiography, including the need to administer contrast medium and eliminate the ambiguity associated with other forms of imaging. This review provides contemporary examples of where IVUS is being used during peripheral intervention as well as representative imaging to serve as a resource for the practising clinician.