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Spiliopoulos S, Georgiadou M, Karahaliou A, Grigoriadis S, Palialexis K, Reppas L, Brountzos E. Feasibility and Clinical Value of Intraprocedural Doppler Ultrasonography Blood Flow Parameters During Peripheral Endovascular Procedures for Limb Salvage: A Pilot Study. J Endovasc Ther 2025; 32:660-668. [PMID: 37288498 DOI: 10.1177/15266028231179838] [Citation(s) in RCA: 1] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 06/09/2023]
Abstract
PURPOSE To investigate whether Doppler ultrasound (DUS) blood flow parameters could serve as quantifiable functional endpoints of peripheral endovascular arterial procedures for chronic limb-threatening ischemia (CLTI), influencing wound healing. METHODS This is a prospective single-center study investigating intraprocedural DUS parameters (pulsatility index [PI] and pedal acceleration time [PAT]) in quantifying immediate hemodynamic alterations in consecutive CLTI patients with wound, ischemia, and foot infection wound class ≥1 undergoing endovascular interventions. Primary endpoints were feasibility of preendovascular and postendovascular treatment measurements of PI/PAT, quantification of immediate PI/PAT modifications of the posterior and anterior foot circulation following revascularization, the correlation between PI and PAT, and 6-month complete wound healing. Secondary endpoints included the 6-month limb salvage (no major amputation) and complete and partial wound healing rates. RESULTS A total of 28 patients (75.0% male) were enrolled, and 68 vessels were treated. The overall mean PAT values significantly decreased from 154.15±70.35 ms preprocedural to 107.21±49.6 ms postprocedural (p<0.01), and the mean PI values significantly increased from 0.93±0.99 to 1.92±1.96 (p<0.01). Postprocedural PAT at the anterior tibial (r2=0.804; p=0.346) and the posterior tibial arteries (r2=0.784; p=0.322) had a strong correlation and postprocedural PI at the anterior tibial (r2=0.704; p=0.301) and the posterior tibial arteries (r2=0.707; p=0.369) had a good correlation with 6-month complete wound healing. The 6-month complete and partial wound healing rates were 38.1% and 47.6%, respectively. Limb salvage was 96.4% and 92.4% at 6 and 12 months of follow-up, respectively. CONCLUSIONS Pedal acceleration time and PI accurately detected immediate hemodynamic changes of foot perfusion following revascularization and could serve as prognostic factors of wound healing in patients with CLTI.Clinical ImpactIntraprocedural measurement of simple Doppler ultrasound blood flow parameters, Pulsatility Index (PI) and Pedal Acceleration Time (PAT), accurately detected immediate hemodynamic changes of foot perfusion following endovascular revascularization and could therefore serve as intraprocedural prognostic factors of wound healing in patients with chronic limb-threatening ischemia. This is the first time that PI has been proposed as a hemodynamic index of successful angioplasty outcome. The optimization of intraprocedural PAT and PI could be used to guide angioplasty and predict clinical success.
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Affiliation(s)
- Stavros Spiliopoulos
- Division of Interventional Radiology, 2nd Department of Radiology, "Attikon" University General Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece
| | - Magdalini Georgiadou
- Division of Interventional Radiology, 2nd Department of Radiology, "Attikon" University General Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece
| | - Anastasia Karahaliou
- Division of Interventional Radiology, 2nd Department of Radiology, "Attikon" University General Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece
| | - Stavros Grigoriadis
- Division of Interventional Radiology, 2nd Department of Radiology, "Attikon" University General Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece
| | - Konstantinos Palialexis
- Division of Interventional Radiology, 2nd Department of Radiology, "Attikon" University General Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece
| | - Lazaros Reppas
- Division of Interventional Radiology, 2nd Department of Radiology, "Attikon" University General Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece
| | - Elias Brountzos
- Division of Interventional Radiology, 2nd Department of Radiology, "Attikon" University General Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece
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Giannopoulos S, Volteas P, Koudounas G, Virvilis D, Labropoulos N. Contemporary Femoropopliteal Stents: Reporting Gaps of Randomized Trials. Ann Vasc Surg 2025; 118:68-82. [PMID: 40254154 DOI: 10.1016/j.avsg.2025.04.110] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/15/2024] [Revised: 04/07/2025] [Accepted: 04/07/2025] [Indexed: 04/22/2025]
Abstract
BACKGROUND Endovascular literature has been under scrutiny due to perceived poor-quality data. This has been attributed to multiple reasons, including but not limited to smaller sample size, absence of standardization of reporting methodology and investigational treatment protocols, and limited funding resources. The goal of the current study was to review the design of randomized controlled trials investigating contemporary stents for the femoropopliteal segment, with reported >70-80% primary efficacy rate and address issues with their respective reporting methodology. METHODS This systematic review and meta-analysis was conducted according to the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines (CRD42024508602). The Medline (PubMed), Scopus, and Cochrane databases were reviewed for randomized controlled trials reporting on the safety and efficacy of femoropopliteal Zilver PTX, Eluvia, Viabahn, and Supera stents through February 2024. Data were collected regarding baseline, lesion, and procedural characteristics and postprocedural outcomes. RESULTS 17 articles were identified, presenting the results of 11 trials. 80% of the studied individuals were males having intermittent claudication (overall 81%; Rutherford class (RC) 2; 8 trials; 29%; RC 3; 8 trials; 46%). The mean preprocedural ankle-brachial index (ABI) was 0.64 (0.56-0.72). Details about run-off vessels, inflow or outflow disease treatment, and antithrombotic regimen compliance were missing in most papers. Only 3 trials had long-term data (≥36 months). Critical information about postprocedural and during follow-up ABI values, amputation rates, and stent fracture rates were not reported in 6, 5, and 13 articles, respectively. The definition of the primary efficacy endpoint was similar in all studies, although the peak systolic velocity (PSV) ratio cutoff that was used ranged from 2.0 to 2.5 (1 study: 2.5; 6 studies: 2.4; 5 studies: 2.0). Post-treatment clinical benefit was often defined as improvement in RC and/or ABI, although individual values were not always provided. CONCLUSION The studies exhibited considerable variation in assessment of outcomes and reporting methodology. Standardized reporting methods for lesion or procedural characteristics and post-treatment clinical benefit need to be established to facilitate translation of clinical trials results to actual practice.
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Affiliation(s)
- Stefanos Giannopoulos
- Division of Vascular and Endovascular Surgery, Department of Surgery, Stony Brook University Hospital, Stony Brook, NY
| | - Panagiotis Volteas
- Division of Vascular and Endovascular Surgery, Department of Surgery, Stony Brook University Hospital, Stony Brook, NY
| | - George Koudounas
- Vascular Unit, 5th Department of Surgery, Aristotle University Medical School, Hippokratio Hospital, Thessaloniki, Greece
| | - Dimitrios Virvilis
- Department of Vascular and Endovascular Surgery, St Francis Hospital & Heart Center, Roslyn, NY
| | - Nicos Labropoulos
- Division of Vascular and Endovascular Surgery, Department of Surgery, Stony Brook University Hospital, Stony Brook, NY.
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Mukhtar H, Rassoulinejad-Mousavi SM, Faghani S, Erickson BJ, Misra S. Pilot Study of Using Machine Learning to Detect Atherosclerotic Renal Artery Stenosis From Spectral Doppler Waveforms. Kidney Int Rep 2025; 10:1213-1222. [PMID: 40303222 PMCID: PMC12034867 DOI: 10.1016/j.ekir.2025.01.012] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/04/2024] [Revised: 12/27/2024] [Accepted: 01/06/2025] [Indexed: 05/02/2025] Open
Abstract
Introduction We investigated whether machine learning (ML) could be used to determine atherosclerotic renal artery stenosis (ARAS) using spectral Doppler waveforms in renal duplex ultrasound (DUS). Methods Patients with unilateral ARAS (contralateral normal kidney) confirmed by angiogram and requiring renal artery stent placement were retrospectively identified from January 2000 to January 2022. The exclusion criteria were unavailable preoperative renal DUS images, concomitant fibromuscular dysplasia, more than 1 renal artery on either side, or a previously placed renal artery stent with in-stent restenosis. Two hundred patients were selected; the affected kidney was used as the positive case and the contralateral kidney was used as the control. The spectral waveforms were reconstructed by manually tracing the outer envelope using WebPlot Digitizer. The graphical coordinates were then converted into 1-dimensional velocity signals. Signals were labeled as ARAS and normal and then randomly divided into training (80%) and testing (20%) datasets. A 1-dimensional convolutional neural network (CNN) was trained to classify the signals and detect ARAS. An Adam optimizer with a learning rate of 0.001 and a cross-entropy loss function were utilized. Five-fold cross-validation was applied, and the model was trained for 1000 epochs. Results A total of 396 signals were used from 198 patients after excluding 2 patients because of inadequate signal extraction (median age = 72 years, females = 51.0%). The overall accuracy of the trained model was 0.95 with a precision of 0.94. The area under the receiver operating characteristic curve was 0.97. Conclusion ML has been successfully employed to detect ARAS using arterial spectral Doppler waveforms in DUS.
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Affiliation(s)
- Haseeb Mukhtar
- Department of Radiology, Mayo Clinic, Rochester, Minnesota, USA
- Vascular Interventional Radiology Translational Laboratory, Mayo Clinic, Rochester, Minnesota, USA
| | - Seyed Moein Rassoulinejad-Mousavi
- Department of Radiology, Mayo Clinic, Rochester, Minnesota, USA
- Radiology Informatics Laboratory, Mayo Clinic, Rochester, Minnesota, USA
- Mayo Clinic Platform, Mayo Clinic, Rochester, Minnesota, USA
- Division of Nephrology and Hypertension, Mayo Clinic, Rochester, Minnesota, USA
| | - Shahriar Faghani
- Department of Radiology, Mayo Clinic, Rochester, Minnesota, USA
- Radiology Informatics Laboratory, Mayo Clinic, Rochester, Minnesota, USA
| | - Bradley J. Erickson
- Department of Radiology, Mayo Clinic, Rochester, Minnesota, USA
- Radiology Informatics Laboratory, Mayo Clinic, Rochester, Minnesota, USA
| | - Sanjay Misra
- Department of Radiology, Mayo Clinic, Rochester, Minnesota, USA
- Vascular Interventional Radiology Translational Laboratory, Mayo Clinic, Rochester, Minnesota, USA
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Tafur JD, Shah KB, White CJ. Renal and Mesenteric Artery Intervention. Interv Cardiol Clin 2025; 14:205-223. [PMID: 40049848 DOI: 10.1016/j.iccl.2024.11.007] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 05/13/2025]
Abstract
Atherosclerotic disease of the abdominal aorta and its visceral branches poses significant health risks due to its potential to cause severe complications. Atherosclerosis affects renal and mesenteric vessels, contributing to renal artery stenosis and mesenteric ischemia, respectively, both of which can result in organ damage and ischemic bowel disease if left untreated. Therapy with guideline-directed medical therapy is advised in all patients. Chronic mesenteric ischemia (CMI) is infrequent and difficult to diagnose illness. Current evidence suggests that compared with open surgical repair, in anatomically suitable lesions, endovascular therapy is the most cost-effective choice for patients with CMI.
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Affiliation(s)
- Jose D Tafur
- Department of Cardiovascular Diseases, John Ochsner Heart & Vascular Center, Ochsner Medical Center, The Ochsner Clinical School, Univ of Queensland, New Orleans, LA, USA
| | - Khanjan B Shah
- Division of Cardiovascular Disease, University of Florida College of Medicine, Gainesville, FL, USA
| | - Christopher J White
- Department of Cardiovascular Diseases, John Ochsner Heart & Vascular Center, Ochsner Medical Center, The Ochsner Clinical School, Univ of Queensland, New Orleans, LA, USA; Department of Cardiology, 3rd Floor, 1514 Jefferson Highway, New Orleans, LA 70121, USA; Department of Cardiology, Ochsner Medical Center, 1514 Jefferson Highway, New Orleans, LA 70121, USA; Value Based Care.
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Fu J, Lin Z, Zhang B, Meng X, Qiu J, Yang M, Zou Y. Evaluating the added value of multiparametric functional MRI in predicting renal function response to renal artery stenting in severe atherosclerotic renal artery stenosis. Magn Reson Imaging 2025; 117:110329. [PMID: 39855366 DOI: 10.1016/j.mri.2025.110329] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/03/2024] [Revised: 01/11/2025] [Accepted: 01/19/2025] [Indexed: 01/27/2025]
Abstract
OBJECTIVE To explore the potential of Intravoxel Incoherent Motion Diffusion (IVIM) and Arterial Spin Labeling (ASL) in predicting the short-term effectiveness of post-revascularization for severe atherosclerotic renal artery stenosis. MATERIAL AND METHODS A retrospective analysis of 88 cases from October 2018 to February 2023 was conducted. Patients were divided into Responder and Non-Responder groups based on renal function outcomes at their last follow-up. Clinical data were compared between the groups, and preoperative functional MRI images were analyzed. ROIs were outlined for the affected and both kidneys. Measurements included ASL-derived renal blood flow (RBF), IVIM's pseudo-diffusion coefficient (D*), perfusion fraction (f), true diffusion coefficient (D), and the conventional apparent diffusion coefficient (ADC).Multivariate logistic regression identified independent clinical predictors of benefit, and a clinical prediction model was developed. Model performance was assessed using Receiver Operating Characteristic (ROC) curves and Decision Curve Analysis(DCA) curves. RESULTS In the training cohort of 54 non-responders and 34 responders, no quantitative parameters of bilateral kidneys showed statistical significance in predicting Responders (all p > 0.05). Pre-treatment eGFR, presence of diabetes, and the D value of the affected kidney were identified as independent factors for predicting short-term treatment effectiveness. The combined clinical-functional imaging model yielded a higher AUC at 0.796 (95 % CI: 0.690-0.897). Decision curve analysis further confirmed the better net benefit of combined model. CONCLUSION Beyond clinical characteristics, functional MRI had the potential to predict response of stenting for severe atherosclerotic renal artery stenosis.
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Affiliation(s)
- Jia Fu
- Department of Radiology, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing, China; Department of Radiology, Peking University First Hospital, Beijing, China
| | - Zhiyong Lin
- Department of Radiology, Peking University First Hospital, Beijing, China
| | - Bihui Zhang
- Department of Interventional Radiology and Vascular Surgery, Peking University First Hospital, Beijing, China
| | - Xiaoyan Meng
- Department of Radiology, Civil Aviation General Hospital, Beijing, China
| | - Jianxing Qiu
- Department of Radiology, Peking University First Hospital, Beijing, China
| | - Min Yang
- Department of Interventional Radiology and Vascular Surgery, Peking University First Hospital, Beijing, China
| | - Yinghua Zou
- Department of Interventional Radiology and Vascular Surgery, Peking University First Hospital, Beijing, China.
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Böhme T, Zeller T, Shishehbor MH, Werner M, Brodmann M, Parise H, Holden A, Lichtenberg M, Parikh SA, Kashyap VS, Pietras C, Tirziu D, Beschorner U, Krishnan P, Niazi KA, Wali AU, Lansky AJ. Chocolate Touch Versus Lutonix Drug-Coated Balloon for Femoropopliteal Lesions in Diabetes: The Chocolate Touch Study. J Endovasc Ther 2025; 32:414-422. [PMID: 37314243 DOI: 10.1177/15266028231179589] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 06/15/2023]
Abstract
BACKGROUND The randomized Chocolate Touch Study demonstrated that in patients undergoing treatment of femoropopliteal artery lesions, the Chocolate Touch drug-coated balloon (DCB) was safe and had superior efficacy at 12 months compared with the Lutonix DCB. We report the prespecified diabetes subanalysis comparing outcomes among patients with and without diabetes mellitus (DM). METHODS Patients with claudication or ischemic rest pain (Rutherford class 2-4) were randomized to Chocolate Touch or Lutonix DCB. The primary efficacy endpoint was DCB success defined as primary patency at 12 months (peak systolic velocity ratio <2.4 by duplex ultrasound without clinically driven target lesion revascularization in the absence of bailout stenting). The primary safety endpoint was freedom from major adverse events at 12 months, a composite of target limb-related death, major amputation, or reintervention. RESULTS A total of 313 patients (38% DM [n=119]) were randomized to either Chocolate Touch (n=66/152) or Lutonix DCB (n=53/161). Among patients with DM, DCB success was 77.2% and 60.5% (p=0.08), and in non-DM patients, DCB success was 80% and 71.3% (p=0.2114) for the Chocolate Touch and Lutonix DCB, respectively. The primary safety endpoint was similar for both cohorts regardless of DM status (interaction test, p=0.96). CONCLUSIONS This randomized trial demonstrated similar safety and efficacy for the treatment of femoropopliteal disease with the Chocolate Touch DCB compared with using the Lutonix DCB regardless of DM status at 12 months.Clinical ImpactThis substudy of the Chocolate Touch Study demonstrated similar safety and efficacy for treatment of femoropopliteal disease of the Chocolate Touch DCB compared with the Lutonix DCB regardless of diabetes (DM) status at 12 months. Endovascular therapy has become the therapy of choice for the treatment of most symptomatic femoropopliteal lesions regardless of DM status. These results give clinicians another option when treating femoropopliteal disease in this high-risk patient population.
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Affiliation(s)
- Tanja Böhme
- Department of Cardiology and Angiology, Medical Center, University of Freiburg, Bad Krozingen, Germany
| | - Thomas Zeller
- Department of Cardiology and Angiology, Medical Center, University of Freiburg, Bad Krozingen, Germany
| | - Mehdi H Shishehbor
- University Hospitals Harrington Heart & Vascular Institute, Cleveland, OH, USA
| | - Martin Werner
- Department of Angiology, Hanusch Hospital, Vienna, Austria
| | | | - Helen Parise
- Division of Cardiovascular Medicine, Yale Cardiovascular Research Group, Yale University School of Medicine, New Haven, CT, USA
| | | | | | - Sahil A Parikh
- Columbia University Irving Medical Center, Columbia University Vagelos College of Physicians and Surgeons, New York, NY, USA
| | - Vikram S Kashyap
- Frederik Meijer Heart and Vascular Institute, Corewell Health, Grand Rapids, MI, USA
| | - Cody Pietras
- Division of Cardiovascular Medicine, Yale Cardiovascular Research Group, Yale University School of Medicine, New Haven, CT, USA
| | - Daniela Tirziu
- Division of Cardiovascular Medicine, Yale Cardiovascular Research Group, Yale University School of Medicine, New Haven, CT, USA
| | - Ulrich Beschorner
- Department of Cardiology and Angiology, Medical Center, University of Freiburg, Bad Krozingen, Germany
| | | | | | - Andreas U Wali
- Penn State Health Holy Spirit Medical Center, Camp Hill, PA, USA
| | - Alexandra J Lansky
- Division of Cardiovascular Medicine, Yale Cardiovascular Research Group, Yale University School of Medicine, New Haven, CT, USA
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Destrieux L. Safety and Effectiveness of Ultrasound-Guided Percutaneous Versus Open Brachial Artery Access: Results of the Multicenter Prospective ARCHIBAL Study Percutaneous or Open Brachial Artery Access. Ann Vasc Surg 2025; 111:231-240. [PMID: 39586528 DOI: 10.1016/j.avsg.2024.10.015] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/13/2024] [Revised: 10/04/2024] [Accepted: 10/08/2024] [Indexed: 11/27/2024]
Abstract
BACKGROUND Although brachial access (BA) has become increasingly used in percutaneous endovascular procedures, results from head-to-head comparisons between open brachial access (OBA) and ultrasound-guided percutaneous brachial access (PBA) are limited in the literature. The objective of our multicenter, prospective, noninterventional ARCHIv BrachiAL study was to compare the safety and efficacy of OBA and PBA to perform peripheral arterial interventions. METHODS From July 2019 to January 2021, all patients needing peripheral endovascular procedures with brachial artery access were consecutively included in the study by 15 surgeons in 14 centers. Procedures were done with 4F-8F (French gauge) introducer sheaths. Arterial closure was done by conventional arterial sutures for OBA and compression or vascular closure devices for PBA. The primary endpoint was the rate of access site complications occurring up to 30 days postoperatively. Secondary endpoints were the occurrence of adverse events and the overall rates of clinical success of BA cannulation and technical success. RESULTS Among the 251 included patients (mean age, 69.9 years; males 70.5%), 122 (48.6%) had an OBA and 129 (51.4%) had a PBA, without significant differences in baseline demographic and clinical characteristics. 38.6% of the patients had the procedure for more than one indication. Clinical success was achieved in all patients and technical success in 244 patients (97.2%). No death, cerebral, cardiac, or embolic complications were reported. Access site complications (primarily hematomas) were significantly (P = 0.02) more frequent in the PBA (8/129; 6.2%) than the OBA group (1/122; 0.8%) or when using introducer sheaths >6F for OBA or vascular closure devices for PBA. CONCLUSIONS Our prospective study confirmed the safety and effectiveness of BA and showed the benefit in terms of safety of OBA versus PBA even when PBA was ultrasound-guided and performed by trained surgeons. It encourages the use of OBA and ultrasound guidance when using PBA. Large and/or randomized studies should be performed to support these results.
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Affiliation(s)
- Laurence Destrieux
- Département de Chirurgie Vasculaire, Clinique Générale, Groupe Vivalto, Annecy, France.
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Bose S, Dun C, Solomon AJ, Black JH, Conte MS, Kalbaugh CA, Woo K, Makary MA, Hicks CW. Editor's Choice - Infrapopliteal Peripheral Vascular Interventions for Claudication are Performed Frequently in the USA and Are Associated with Poor Long Term Outcomes. Eur J Vasc Endovasc Surg 2025; 69:89-101. [PMID: 38906366 PMCID: PMC11655707 DOI: 10.1016/j.ejvs.2024.06.017] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/14/2023] [Revised: 05/17/2024] [Accepted: 06/13/2024] [Indexed: 06/23/2024]
Abstract
OBJECTIVE Infrapopliteal peripheral vascular interventions (PVIs) for claudication are still performed in the USA. This study aimed to evaluate whether infrapopliteal PVI is associated with worse long term outcomes than isolated femoropopliteal PVI for treatment of claudication. METHODS A retrospective analysis of fee for service claims in a national administrative database was conducted using 100% of the Medicare fee for service claims between 2017 and 2019 to capture all Medicare beneficiaries who underwent an index infra-inguinal PVI for claudication. Hierarchical Cox proportional hazards models were performed to assess the association of infrapopliteal PVI with conversion to chronic limb threatening ischaemia (CLTI), repeat PVI, and major amputation. RESULTS In total, 36 147 patients (41.1% female; 89.7% age ≥ 65 years; 79.0% non-Hispanic White ethnicity) underwent an index PVI for claudication, of whom 32.6% (n = 11 790) received an infrapopliteal PVI. Of these, 61.4% (n = 7 245) received a concomitant femoropopliteal PVI and 38.6% (n = 4 545) received an isolated infrapopliteal PVI. The median follow up time was 3.5 years (interquartile range 2.7, 4.3). Patients receiving infrapopliteal PVI had a higher three year cumulative incidence of conversion to CLTI (26.0%; 95% confidence interval [CI] 24.9 - 27.2% vs. 19.9%; 95% CI 19.1 - 20.7%), repeat PVI (56.0%; 95% CI 54.8 - 57.3% vs. 45.7%; 95% CI 44.9 - 46.6%), and major amputation (2.2%; 95% CI 1.8 - 2.6% vs. 1.3%; 95% CI 1.1 - 1.5%) compared with patients receiving isolated femoropopliteal PVI. After adjusting for patient and physician level characteristics, the risk of conversion to CLTI (adjusted hazard ratio [aHR] 1.31, 95% CI 1.23 - 1.39), repeat PVI (aHR 1.12, 95% CI 1.05 - 1.20), and major amputation (aHR 1.72, 95% CI 1.42 - 2.07) remained significantly higher for patients receiving infrapopliteal PVI. An increasing number of infrapopliteal vessels treated during the index intervention was associated with increasingly poor outcomes (p < .001 for trend). CONCLUSION Infrapopliteal PVI for claudication is associated with worse long term outcomes relative to isolated femoropopliteal PVI.
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Affiliation(s)
- Sanuja Bose
- Division of Vascular Surgery and Endovascular Therapy, Department of Surgery, The Johns Hopkins School of Medicine, Baltimore, MD, USA
| | - Chen Dun
- Department of Surgery, The Johns Hopkins School of Medicine, Baltimore, MD, USA; Department of Biomedical Informatics and Data Science, Johns Hopkins University School of Medicine, Baltimore, MD, USA
| | | | - James H Black
- Division of Vascular Surgery and Endovascular Therapy, Department of Surgery, The Johns Hopkins School of Medicine, Baltimore, MD, USA
| | - Michael S Conte
- Division of Vascular and Endovascular Surgery, Department of Surgery, University of California San Francisco Medical Center, San Francisco, CA, USA
| | - Corey A Kalbaugh
- Department of Epidemiology and Biostatistics, Indiana University School of Public Health-Bloomington, Bloomington, IN, USA
| | - Karen Woo
- Division of Vascular Surgery, University of California, Los Angeles, CA, USA
| | - Martin A Makary
- Department of Surgery, The Johns Hopkins School of Medicine, Baltimore, MD, USA
| | - Caitlin W Hicks
- Division of Vascular Surgery and Endovascular Therapy, Department of Surgery, The Johns Hopkins School of Medicine, Baltimore, MD, USA.
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Wilkins LR, Sabri SS, Misra S. The 2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS/SIR/VESS Guideline for the Management of Lower Extremity Peripheral Artery Disease: Pertinent Points for the Interventional Radiologist. J Vasc Interv Radiol 2024; 35:1743-1751. [PMID: 39244084 DOI: 10.1016/j.jvir.2024.08.024] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/12/2024] [Revised: 08/27/2024] [Accepted: 08/29/2024] [Indexed: 09/09/2024] Open
Affiliation(s)
- Luke R Wilkins
- Department of Radiology and Medical Imaging, Section of Vascular and Interventional Radiology, University of Virginia School of Medicine, Charlottesville, Virginia.
| | - Saher S Sabri
- Department of Radiology, Section of Interventional Radiology, MedStar Washington Hospital Center, Washington, DC
| | - Sanjay Misra
- Department of Radiology, Section of Vascular and Interventional Radiology, Mayo Clinic, Rochester, Minnesota
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Drachman DE, Metzger DC, Jain A, Sachar R, El-Sayed Abbas A, Rosenfield K, Ansel GM. De Novo Atherosclerotic Renal Artery Stenosis Covered Stent Treatment for Resistant Hypertension (ARTISAN) Results. JOURNAL OF THE SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY & INTERVENTIONS 2024; 3:102400. [PMID: 39807237 PMCID: PMC11725122 DOI: 10.1016/j.jscai.2024.102400] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Subscribe] [Scholar Register] [Received: 07/07/2024] [Revised: 09/21/2024] [Accepted: 09/26/2024] [Indexed: 01/16/2025]
Abstract
Background Atherosclerotic renal artery stenosis (ARAS) may provoke hypertension and/or impaired kidney function. Some patients develop uncontrolled hypertension and deteriorating kidney function despite optimal medical therapy. In these patients, endovascular treatment is an important therapeutic option. ARTISAN was a prospective, open-label, single-arm, multicenter clinical trial to evaluate the safety and effectiveness of the iCast RX covered stent both functionally for reestablishing renal artery flow, and clinically for controlling resistant hypertension. Methods Patients considered for enrollment had average systolic blood pressure (SBP) ≥155 mm Hg despite taking 3 antihypertensive medications. Prior to enrollment and covered stent placement, angiographic confirmation of ARAS ≥80% with physiologic significance was required. Clinical assessments were performed at 30 days, 9 months, and annually through 36 months. Covered stent safety and efficacy were based on 9-month coprimary end points, including primary vessel patency and SBP improvement at 9 months. Secondary outcomes included target lesion revascularization, major adverse events, and secondary patency. Results Sixty-eight of the planned 138 subjects were enrolled. Primary patency was seen in 94.3% of subject lesions; the mean SBP reduction was 15.7 mm Hg. The functional and clinical end points met prespecified performance goals of 70% primary patency (P < .0001) and ≥10 mm Hg SBP decrease (P = .0192), respectively, at 9 months. Six subjects (8.8%) experienced 7 major adverse events within 36 months. The clinically driven target lesion revascularization rate was 7.3% at 36 months. Conclusions The high primary patency and improvement in SBP, persisting through 36 months, suggest that the iCast RX covered stent is safe and effective for the treatment of appropriately selected patients with ARAS.
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Affiliation(s)
| | | | - Ashit Jain
- California Cardiovascular Consultation and Medical Associates, Fremont, California
| | - Ravish Sachar
- North Carolina Heart and Vascular, Raleigh, North Carolina
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11
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Khawer A, Diaz CF. Laser Atherectomy and Restenting of the Superficial Femoral Artery Using GORE VIABAHN Endoprosthesis Following Failure of Both Bare-Metal Stenting and Surgical Revascularization. Case Rep Vasc Med 2024; 2024:4950420. [PMID: 39534783 PMCID: PMC11557178 DOI: 10.1155/2024/4950420] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/20/2023] [Revised: 06/12/2024] [Accepted: 10/19/2024] [Indexed: 11/16/2024] Open
Abstract
Peripheral arterial disease (PAD) affects more than 230 million adults worldwide. Revascularization via angioplasty is a common method to manage stenosis in the superficial femoral artery (SFA). In-stent restenosis, however, is a common complication in endovascular interventions, especially in the SFA. Here, we present a case that involves recanalization of the SFA in a patient with a previously occluded stent and failed surgical revascularization. This patient initially presented with an occluded SFA which was stented. Four years later, the stent was reoccluded and surgical endarterectomy of the artery was performed with partial removal of the stent. Ten years later, the SFA is again occluded. Recanalization of the SFA using laser atherectomy and restenting of the occluded stent with GORE VIABAHN endoprosthesis was performed successfully. The combination of such methods is a suitable way to manage chronic lesions and minimize restenosis in patients with PAD.
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Affiliation(s)
- Ahmed Khawer
- DeBusk College of Osteopathic Medicine, Lincoln Memorial University, Harrogate, Tennessee, USA
| | - Claro F. Diaz
- Department of Cardiology, Methodist Le Bonheur Healthcare, Memphis, Tennessee, USA
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12
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McEvoy JW, McCarthy CP, Bruno RM, Brouwers S, Canavan MD, Ceconi C, Christodorescu RM, Daskalopoulou SS, Ferro CJ, Gerdts E, Hanssen H, Harris J, Lauder L, McManus RJ, Molloy GJ, Rahimi K, Regitz-Zagrosek V, Rossi GP, Sandset EC, Scheenaerts B, Staessen JA, Uchmanowicz I, Volterrani M, Touyz RM. 2024 ESC Guidelines for the management of elevated blood pressure and hypertension. Eur Heart J 2024; 45:3912-4018. [PMID: 39210715 DOI: 10.1093/eurheartj/ehae178] [Citation(s) in RCA: 1] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 09/04/2024] Open
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13
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Forsyth AM, Simons JP. An Assessment of the Society for Vascular Surgery Appropriate Use Criteria for the Management of Intermittent Claudication: Key Findings and Considerations for Implementation. Ann Vasc Surg 2024; 107:13-16. [PMID: 37944895 DOI: 10.1016/j.avsg.2023.10.006] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/26/2023] [Accepted: 10/26/2023] [Indexed: 11/12/2023]
Abstract
BACKGROUND Several concerns have been raised over the past several years about the potential for overuse of vascular interventions for peripheral artery disease. These interventions can have serious complications, including limb loss. Given that the natural history of intermittent claudication rarely includes limb loss, it is critically important that interventions to treat it have appropriate indications. METHODS To address this matter, the Society for Vascular Surgery published an appropriate use criteria (AUC) document for the management of intermittent claudication in 2022. Using the rigorously studied University of California Los Angeles RAND Appropriateness Method, the rating panel assessed the appropriateness of 2,280 scenarios for [1] the initial management and [2] the management after a failed trial of exercise therapy. RESULTS The findings of the rating panel included that medical management and exercise therapy are appropriate initial management in all scenarios. There were several scenarios in which revascularization was also considered appropriate, mainly influenced by severity of physical limitations and favorable lesion characteristics. When considering management after a failed trial of exercise, guiding principles cited by the rating panel included durability of intervention, smoking cessation, and evidence of prior good-faith effort at exercise therapy. There were many scenarios which were indeterminate. With respect to the infrapopliteal segment, the rating panelists unanimously agreed to forgo individual scenario ratings, since they deemed the risks outweigh the benefits in all cases. CONCLUSIONS The Society for Vascular Surgery (SVS) AUC for intermittent claudication represents an important effort to identify and reduce overuse. There are several considerations for how they should be used. The simplest application is by practicing clinicians, at the bedside, as they engage in shared decision-making with patients. The matter of their use by payors is more complex. Ideally, decisions on how to best use AUC require additional study of their performance before they are used by payors for anything. Finally, these AUC have identified a myriad of areas where evidence is lacking. The AUC provide important targets for future research to improve the care of patients with intermittent claudication.
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Affiliation(s)
- Alexandra M Forsyth
- Division of Vascular and Endovascular Surgery, UMass Chan Medical School, Worcester, MA
| | - Jessica P Simons
- Division of Vascular and Endovascular Surgery, UMass Chan Medical School, Worcester, MA.
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14
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Hicks CW, Conte MS, Dun C, Makary MA. Appropriateness of Care Measures: A Novel Approach to Quality. Ann Vasc Surg 2024; 107:186-194. [PMID: 38582205 PMCID: PMC11365803 DOI: 10.1016/j.avsg.2024.01.029] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/02/2024] [Accepted: 01/18/2024] [Indexed: 04/08/2024]
Abstract
The clinical judgment of a physician is one of the most important aspects of medical quality, yet it is rarely captured with quality measures in use today. We propose a novel approach using individualized physician benchmarking that measures the appropriateness of care that a physician delivers by looking at their practice pattern in a specific clinical situation. A prime application of our novel approach to appropriateness measures is the surgical management of peripheral artery disease and claudication. We discuss 4 potential consensus metrics for the treatment of claudication that explore appropriateness of care of claudication management and are meaningful, actionable, and quantifiable. Given the multitude of medical specialties involved in the care of patients with peripheral artery disease and the consequences of both preemptive and delayed care, it is in all of our interests to promote data transparency with confidential communications to outlier physicians while advocating for evidence-based management.
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Affiliation(s)
- Caitlin W Hicks
- Division of Vascular Surgery and Endovascular Therapy, Johns Hopkins University School of Medicine, Baltimore, MD.
| | - Michael S Conte
- Division of Vascular and Endovascular Surgery, Department of Surgery, University of California, San Francisco, San Francisco, CA
| | - Chen Dun
- Department of Surgery, Johns Hopkins University School of Medicine, Baltimore, MD
| | - Martin A Makary
- Department of Surgery, Johns Hopkins University School of Medicine, Baltimore, MD
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15
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Weaver ML. Lessons Learned from Coronary Revascularization Appropriateness Statements for Application to Peripheral Artery Disease. Ann Vasc Surg 2024; 107:72-75. [PMID: 38582214 DOI: 10.1016/j.avsg.2023.11.060] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/30/2023] [Accepted: 11/22/2023] [Indexed: 04/08/2024]
Abstract
Appropriate Use Criteria (AUC) are evidence-based criteria developed in a methodologically robust manner with the input of expert providers across a wide range of disciplines and practice settings. AUC have been successfully implemented in the diagnosis and management of a wide range of cardiovascular disease processes. AUC have demonstrated clear potential for influencing meaningful change in practice patterns with regards to high-value, high-quality care in cardiovascular pathologies. Potential for similar impact in the management of peripheral artery disease, specifically for patients presenting with intermittent claudication (IC), may be limited due to unique challenges. These challenges include multidisciplinary interventionalists, variability in existing AUC across specialties, and financial incentives influencing physician behavior. AUC serve to benefit patients by improving outcomes, and adoption of AUC is a critical step toward improving the quality of care provided to patients with IC. Societal support is necessary for effective AUC implementation.
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Affiliation(s)
- M Libby Weaver
- Division of Vascular and Endovascular Surgery, University of Virginia School of Medicine, Charlottesville, VA.
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16
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Dionne AR, Columbo JA, Block C, Hopley CW. Revascularization in a Time After CORAL. JACC Case Rep 2024; 29:102501. [PMID: 39359498 PMCID: PMC11442163 DOI: 10.1016/j.jaccas.2024.102501] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/22/2024] [Revised: 07/12/2024] [Accepted: 07/24/2024] [Indexed: 10/04/2024]
Abstract
Revascularization of renal artery stenosis became less common following randomized controlled trials that failed to demonstrate benefit in low-risk patients. An 88-year-old patient with recurrent acute pulmonary edema and progressive kidney disease in the setting of high-grade renal artery stenosis, a phenotype excluded from these trials, underwent revascularization.
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Affiliation(s)
- Anne R. Dionne
- Geisel School of Medicine at Dartmouth College, Hanover, New Hampshire, USA
| | - Jesse A. Columbo
- Geisel School of Medicine at Dartmouth College, Hanover, New Hampshire, USA
- Section of Vascular Surgery, Heart and Vascular Center, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA
| | - Clay Block
- Geisel School of Medicine at Dartmouth College, Hanover, New Hampshire, USA
- Department of Medicine, Section of Hypertension and Nephrology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA
| | - Charles W. Hopley
- Geisel School of Medicine at Dartmouth College, Hanover, New Hampshire, USA
- Department of Medicine, Section of Hypertension and Nephrology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA
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17
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Li P, Yang X, Niu G, Yan Z, Zhang B, Yang M. Percutaneous Transluminal Renal Angioplasty for Pediatric Hypertension Secondary to Total Renal Artery Occlusion. J Vasc Interv Radiol 2024; 35:1332-1339. [PMID: 38499268 DOI: 10.1016/j.jvir.2024.03.011] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/23/2023] [Revised: 03/04/2024] [Accepted: 03/10/2024] [Indexed: 03/20/2024] Open
Abstract
PURPOSE To assess the feasibility and effectiveness of percutaneous transluminal renal angioplasty (PTRA) for pediatric renovascular hypertension (RVH) secondary to total renal artery occlusion (RAO). MATERIALS AND METHODS From 2011 to 2021, 13 pediatric patients with RVH confirmed with 14 renal artery occlusions were reviewed. The mean age was 11.2 years (range, 4-16 years). Nine occlusions involved main artery occlusion, and 5 involved branch occlusion. Blood pressure ratio (BPR) was defined as the ratio of the actual measured blood pressure (BP) value to the 95th percentile value adjusted for age, sex, and height. RESULTS PTRA was performed in 9 patients (9/13, 69%). Technical success was achieved in 5 patients (5/9, 56%), with stent placement in 2 children (2/9, 22%). During the 12-month follow-up, restenosis was identified in both of the stent-receiving patients at the 12-month follow-up visit (2/9, 22%). Mean systolic BPR decreased from 1.20 (SD ± 0.07) to 0.96 (SD ± 0.06; P = .003), mean diastolic BPR decreased from 1.19 (SD ± 0.07) to 0.95 (SD ± 0.08; P = .005), and the number of medications required decreased from 3.8 (SD ± 0.8) to 2.4 (SD ± 0.9; P = .052) after PTRA. Subsequent to PTRA, the mean glomerular filtration rate of the occluded kidney improved from 19.5 mL/min (SD ± 12.3) to 36.3 mL/min (SD ± 10.8; P = .007), and the mean longitudinal dimension of the affected kidneys significantly increased from 8.2 cm (SD ± 1.5) to 9.2 cm (SD ± 1.7; P = .006). CONCLUSIONS Endovascular treatment is often feasible for pediatric patients with RAO, results in acceptable BP control, and preserves renal function.
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Affiliation(s)
- Pengyu Li
- Department of Interventional Radiology and Vascular Surgery, Peking University First Hospital, Beijing, China
| | - Xinzhi Yang
- Department of Interventional Radiology and Vascular Surgery, Peking University First Hospital, Beijing, China
| | - Guochen Niu
- Department of Interventional Radiology and Vascular Surgery, Peking University First Hospital, Beijing, China
| | - Ziguang Yan
- Department of Interventional Radiology and Vascular Surgery, Peking University First Hospital, Beijing, China
| | - Bihui Zhang
- Department of Interventional Radiology and Vascular Surgery, Peking University First Hospital, Beijing, China
| | - Min Yang
- Department of Interventional Radiology and Vascular Surgery, Peking University First Hospital, Beijing, China.
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18
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Lubas A, Zegadło A, Frankowska E, Jędrych E, Lubas T, Grzywacz A, Leśniak K, Niemczyk S. Absolute Stenosis Measures of Renal Artery Independently Influence Kidney Perfusion in Contrast-Enhanced Multidetector Computed Tomography. J Clin Med 2024; 13:5022. [PMID: 39274236 PMCID: PMC11395791 DOI: 10.3390/jcm13175022] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/15/2024] [Revised: 08/22/2024] [Accepted: 08/22/2024] [Indexed: 09/16/2024] Open
Abstract
Background: A renal artery lumen reduction of ≥60% indicates hemodynamically significant stenosis and is one of the main criteria for invasive revascularization. We hypothesize that direct parameters describing renal artery stenosis (RAS) could better correlate with renal blood flow and improve the criterion for revascularization. This study aimed to investigate RAS parameters independently associated with renal blood flow estimated in contrast-enhanced multidetector computed tomography (CE-MDCT). Methods: Ultrasound Doppler dynamic renal cortical perfusion (dRCP), CE-MDCT with cortical blood flow (CBF), and RAS assessment in the form of cross-sectional area reduction (CSAR), maximal diameter reduction (MaxDR), mean diameter (MeD), and minimal diameter (MinD) were investigated. Results: CBF correlated with CSAR (r = -0.422, p = 0.003), MeD (r = 0.344, p = 0.005) and MinD (r = 0.348, p= 0.005), whereas RCP correlated only with MeD (r = 0.357, p = 0.005) and MinD (r = 0.427, p< 0.001). In multivariable regression, only MeD was independently associated with CBF (R2 = 0.179; p < 0.001), and MeD < 3.5 mm substantially indicated CBF < 175 mL/100 g/min in ROC analysis. Conclusions: The directly measured mean diameter of RAS is independently associated with renal cortex blood flow and is probably a more appropriate parameter for the invasive RAS treatment criterion.
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Affiliation(s)
- Arkadiusz Lubas
- Department of Internal Diseases Nephrology and Dialysis, Military Institute of Medicine-National Research Institute, 04-141 Warsaw, Poland
| | - Arkadiusz Zegadło
- Department of Radiology, Military Institute of Medicine-National Research Institute, 04-141 Warsaw, Poland
| | - Emilia Frankowska
- Department of Radiology, Military Institute of Medicine-National Research Institute, 04-141 Warsaw, Poland
| | - Ewelina Jędrych
- Department of Internal Diseases Nephrology and Dialysis, Military Institute of Medicine-National Research Institute, 04-141 Warsaw, Poland
| | - Tymoteusz Lubas
- Faculty of Medicine, Medical University of Gdańsk, 80-210 Gdańsk, Poland
| | - Anna Grzywacz
- Department of Internal Diseases Nephrology and Dialysis, Military Institute of Medicine-National Research Institute, 04-141 Warsaw, Poland
| | - Ksymena Leśniak
- Department of Internal Diseases Nephrology and Dialysis, Military Institute of Medicine-National Research Institute, 04-141 Warsaw, Poland
| | - Stanisław Niemczyk
- Department of Internal Diseases Nephrology and Dialysis, Military Institute of Medicine-National Research Institute, 04-141 Warsaw, Poland
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19
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Dreyfus I, Zilinyi R, Radhakrishnann J, Parikh SA. Therapy for Renal Artery Stenosis: A Call for Change. J Endovasc Ther 2024; 31:522-532. [PMID: 36415917 DOI: 10.1177/15266028221134884] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/17/2024]
Abstract
CLINICAL IMPACT We present a brief case description of a patient who benefitted from stenting in ARAS and provide a comprehensive review of ARAS; its prevalence, pathophysiology, clinical manifestations, diagnosis and treatment. We review the evidence for and against stenting in ARAS as well as consensus guidelines for stenting. Our review is valuable as we argue that stenting in ARAS is underutilized and the randomized control data for stenting in those patients who may benefit most is lacking. Our review will provide an important perspective for clinicians faced with decisions of how to treat ARAS.
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Affiliation(s)
- Isaac Dreyfus
- Division of Cardiology, Department of Medicine, University of California Los Angeles, Los Angeles, CA, USA
| | - Robert Zilinyi
- Division of Cardiology, Department of Medicine, New York-Presbyterian Hospital/Columbia University Irving Medical Center, New York, NY, USA
| | - Jai Radhakrishnann
- Division of Nephrology, Department of Medicine, New York-Presbyterian Hospital/Columbia University Irving Medical Center, New York, NY, USA
| | - Sahil A Parikh
- Division of Cardiology, Department of Medicine, New York-Presbyterian Hospital/Columbia University Irving Medical Center, New York, NY, USA
- Center for Interventional Cardiovascular Care and Division of Cardiology, Department of Medicine, Columbia University Irving Medical Center, New York, NY, USA
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20
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Pyun AJ, Goodney PP, Eldrup-Jorgensen J, Wadzinski J, Secemsky EA, Cigarroa JE. Device regulation and surveillance in vascular care: Challenges and opportunities. Catheter Cardiovasc Interv 2024; 104:84-91. [PMID: 38639136 DOI: 10.1002/ccd.31053] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/31/2024] [Accepted: 04/02/2024] [Indexed: 04/20/2024]
Abstract
Cardiovascular devices are essential for the treatment of cardiovascular diseases including cerebrovascular, coronary, valvular, congenital, peripheral vascular and arrhythmic diseases. The regulation and surveillance of vascular devices in real-world practice, however, presents challenges during each individual product's life cycle. Four examples illustrate recent challenges and questions regarding safety, appropriate use and efficacy arising from FDA approved devices used in real-world practice. We outline potential pathways wherein providers, regulators and payors could potentially provide high-quality cardiovascular care, identify safety signals, ensure equitable device access, and study potential issues with devices in real-world practice.
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Affiliation(s)
- Alyssa J Pyun
- Division of Vascular Surgery and Endovascular Therapy, Keck Medical Center of University of Southern California, Los Angeles, California, USA
| | - Philip P Goodney
- Heart and Vascular Center, Dartmouth Health, Lebanon, New Hampshire, USA
- The Society for Vascular Surgery's Patient Safety Organization (SVS-PSO) and Vascular Quality Initiative (VQI), Chicago, Illinois, USA
| | - Jens Eldrup-Jorgensen
- The Society for Vascular Surgery's Patient Safety Organization (SVS-PSO) and Vascular Quality Initiative (VQI), Chicago, Illinois, USA
| | - James Wadzinski
- The Society for Vascular Surgery's Patient Safety Organization (SVS-PSO) and Vascular Quality Initiative (VQI), Chicago, Illinois, USA
| | - Eric A Secemsky
- Division of Vascular Interventions, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA
| | - Joaquin E Cigarroa
- Division of Cardiovascular Medicine, Department of Medicine, Oregon Health Sciences University (OHSU), Portland, Oregon, USA
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21
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Zarrella MN, Wynne K, Smith P, Duraiyarasan S, Elbey MA. When Revascularization May Be Appropriate in Atherosclerotic Renal Artery Stenosis. Cureus 2024; 16:e64854. [PMID: 39156425 PMCID: PMC11330315 DOI: 10.7759/cureus.64854] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 07/17/2024] [Indexed: 08/20/2024] Open
Abstract
Renal artery stenosis (RAS) is a condition that involves the narrowing of one or both renal arteries, most commonly caused by either atherosclerosis or fibroplasia. RAS can present in a multitude of clinical manifestations involving hypertension (HTN), heart failure, and renal failure. Current recommendations for treating patients with RAS involve strict medical therapy often without invasive therapies. However, in more complicated patients with RAS, recent clinical studies and guidelines have offered varying recommendations, which has presented challenges in managing these cases. This review aims to summarize current evidence to best evaluate which patients with RAS may benefit from renal artery revascularization as opposed to medical therapy alone.
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Affiliation(s)
| | - Kolu Wynne
- Internal Medicine, St Mary's Hospital, Waterbury, USA
| | - Phelese Smith
- Internal Medicine, St Mary's Hospital, Waterbury, USA
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22
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Gornik HL, Aronow HD, Goodney PP, Arya S, Brewster LP, Byrd L, Chandra V, Drachman DE, Eaves JM, Ehrman JK, Evans JN, Getchius TSD, Gutiérrez JA, Hawkins BM, Hess CN, Ho KJ, Jones WS, Kim ESH, Kinlay S, Kirksey L, Kohlman-Trigoboff D, Long CA, Pollak AW, Sabri SS, Sadwin LB, Secemsky EA, Serhal M, Shishehbor MH, Treat-Jacobson D, Wilkins LR. 2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS/SIR/VESS Guideline for the Management of Lower Extremity Peripheral Artery Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol 2024; 83:2497-2604. [PMID: 38743805 DOI: 10.1016/j.jacc.2024.02.013] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 05/23/2024]
Abstract
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.
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23
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Akai T, Ninomiya S, Kaneko T. Superficial femoral artery pseudoaneurysm at implantation site of drug eluting stent discovered due to bacteremia: A case report. World J Clin Cases 2024; 12:3194-3199. [PMID: 38898869 PMCID: PMC11185371 DOI: 10.12998/wjcc.v12.i17.3194] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/09/2024] [Revised: 04/20/2024] [Accepted: 04/28/2024] [Indexed: 06/04/2024] Open
Abstract
BACKGROUND Drug-eluting stents (DES) are used to treat lower extremity arterial disease. During DES treatment, aneurysmal degeneration occasionally occurs, especially with fluoropolymer-based DES. However, the incidence of pseudoaneurysms after DES placement is rarely reported in the lower extremity region, although there have been several reports on pseudoaneurysm formation after DES pla-cement in the coronary artery region. CASE SUMMARY We report the case of a 64-year-old man who presented with fever and pain in his left hand after dialysis. Bacteremia was diagnosed by blood culture, and after admission, he developed pain on the medial side of the right thigh. A pseudoaneurysm was observed in the right superficial femoral artery (SFA) at the proximal end of a previously placed DES. The bacteremia was thought to have been caused by a pseudoaneurysm of the left superficial brachial artery, and the pseudoaneurysm of the left superficial brachial artery was removed after antibiotic treatment. The pseudoaneurysm of the right SFA rapidly expanded after admission, but the expansion rate was reduced after infection control. Seven months after the first admission, the pseudoaneurysm of the left SFA was re-moved and in situ revascularization performed using a rifampicin-soaked Dacron graft. CONCLUSION Although pseudoaneurysm after DES placement in the lower extremity region is rare, it must be considered in patients with bacteremia.
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Affiliation(s)
- Takafumi Akai
- Department of Vascular Surgery, Asahi General Hospital, Chiba, Asahi 289-2511, Japan
| | - Shintarou Ninomiya
- Department of Vascular Surgery, Asahi General Hospital, Chiba, Asahi 289-2511, Japan
| | - Takanori Kaneko
- Department of Vascular Surgery, Asahi General Hospital, Chiba, Asahi 289-2511, Japan
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24
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Gornik HL, Aronow HD, Goodney PP, Arya S, Brewster LP, Byrd L, Chandra V, Drachman DE, Eaves JM, Ehrman JK, Evans JN, Getchius TSD, Gutiérrez JA, Hawkins BM, Hess CN, Ho KJ, Jones WS, Kim ESH, Kinlay S, Kirksey L, Kohlman-Trigoboff D, Long CA, Pollak AW, Sabri SS, Sadwin LB, Secemsky EA, Serhal M, Shishehbor MH, Treat-Jacobson D, Wilkins LR. 2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS/SIR/VESS Guideline for the Management of Lower Extremity Peripheral Artery Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation 2024; 149:e1313-e1410. [PMID: 38743805 DOI: 10.1161/cir.0000000000001251] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 05/16/2024]
Abstract
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.
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25
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Bose S, McDermott KM, Dun C, Mao J, Solomon AJ, Black JH, Columbo JA, Conte MS, Deery SE, Goodney PP, Kalathiya R, Kalbaugh CA, Siracuse JJ, Woo K, Makary MA, Hicks CW. Infrapopliteal Endovascular Interventions for Claudication Are Associated with Poor Long-Term Outcomes in Medicare-Matched Registry Patients. Ann Surg 2024:00000658-990000000-00916. [PMID: 38841837 PMCID: PMC11725175 DOI: 10.1097/sla.0000000000006368] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 06/07/2024]
Abstract
BACKGROUND There are limited data supporting or opposing the use of infrapopliteal peripheral vascular interventions (PVI) for the treatment of claudication. OBJECTIVES We aimed to evaluate the association of infrapopliteal PVI with long-term outcomes compared with isolated femoropopliteal PVI for the treatment of claudication. METHODS We conducted a retrospective analysis of all patients in the Medicare-matched Vascular Quality Initiative database who underwent an index infrainguinal PVI for claudication from January 2004-December 2019 using Cox proportional hazards models. RESULTS Of 14,261 patients (39.9% female; 85.6% age ≥65 years, 87.7% non-Hispanic white) who underwent an index infrainguinal PVI for claudication, 16.6% (N=2,369) received an infrapopliteal PVI. The median follow-up after index PVI was 3.7 years (IQR 2.1-6.1). Compared to patients who underwent isolated femoropopliteal PVI, patients receiving any infrapopliteal PVI had a higher 3-year cumulative incidence of conversion to CLTI (33.3% vs. 23.8%; P<0.001); repeat PVI (41.0% vs. 38.2%; P<0.01); and amputation (8.1% vs. 2.8%; P<0.001). After risk-adjustment, patients undergoing infrapopliteal PVI had a higher risk of conversion to CLTI (aHR 1.39, 95% CI, 1.25-1.53); repeat PVI (aHR 1.10, 95% CI, 1.01-1.19); and amputation (aHR 2.18, 95% CI, 1.77-2.67). Findings were consistent after adjusting for competing risk of death; in a 1:1 propensity-matched analysis; and in subgroup analyses stratified by TASC disease, diabetes, and end-stage kidney disease. CONCLUSIONS Infrapopliteal PVI is associated with worse long-term outcomes than femoropopliteal PVI for claudication. These risks should be discussed with patients.
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Affiliation(s)
- Sanuja Bose
- Division of Vascular Surgery and Endovascular Therapy, The Johns Hopkins University School of Medicine, Baltimore, MD
| | | | - Chen Dun
- Department of Surgery, The Johns Hopkins University School of Medicine, Baltimore, MD
- Department of Biomedical Informatics and Data Science, The Johns Hopkins University School of Medicine, Baltimore, MD
| | - Jialin Mao
- Department of Population Health Sciences, Weill Cornell Medical College, New York, NY
| | | | - James H. Black
- Division of Vascular Surgery and Endovascular Therapy, The Johns Hopkins University School of Medicine, Baltimore, MD
| | - Jesse A. Columbo
- Section of Vascular Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH
| | - Michael S. Conte
- University of California San Francisco Medical Center, San Francisco, CA
| | | | - Philip P. Goodney
- Section of Vascular Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH
| | - Rohan Kalathiya
- Division of Cardiology, The Johns Hopkins University School of Medicine, Baltimore, MD
| | - Corey A. Kalbaugh
- Department of Epidemiology and Biostatistics, Indiana University School of Public Health-Bloomington, Bloomington, IN
| | - Jeffrey J. Siracuse
- Division of Vascular and Endovascular Surgery, Boston University Chobanian and Avedisian School of Medicine, Boston, MA
| | - Karen Woo
- Division of Vascular Surgery, University of California, Los Angeles, CA
| | - Martin A. Makary
- Department of Surgery, The Johns Hopkins University School of Medicine, Baltimore, MD
| | - Caitlin W. Hicks
- Division of Vascular Surgery and Endovascular Therapy, The Johns Hopkins University School of Medicine, Baltimore, MD
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Le Q, Mills A, Denton A, Weaver ML. A systematic review of existing appropriate use criteria in cardiovascular disease from the last 15 years. Semin Vasc Surg 2024; 37:101-110. [PMID: 39151990 DOI: 10.1053/j.semvascsurg.2024.03.001] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/04/2024] [Revised: 03/16/2024] [Accepted: 03/25/2024] [Indexed: 08/19/2024]
Abstract
Appropriate use criteria (AUC) aim to impact the provision of high-value care. This scoping review identified AUC regarding the procedural and operative treatment of cardiovascular disease and described the evolution of AUC in this space over time, including changes in the focus, strategy, and language of AUC. The summative presentation of these AUC identifies elements of AUC that may lead to successes in, and barriers to, implementation across disease processes, specialties, and societies. AUC topics include coronary artery disease, peripheral artery disease, valvular disease, venous disease, renal artery stenosis, and mesenteric ischemia, among others.
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Affiliation(s)
- Quang Le
- University of Virginia School of Medicine, Charlottesville, VA
| | - Aqiyl Mills
- Department of Surgery, University of Virginia, Charlottesville, VA
| | - Andrea Denton
- Claude Moore Health Sciences Library, University of Virginia, Charlottesville, VA
| | - M Libby Weaver
- Division of Vascular and Endovascular Surgery, University of Virginia Health System, 1215 Lee Street, PO Box 800679, Charlottesville, VA 22908-0679.
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27
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Kawai K, Rahman MT, Nowicki R, Kolodgie FD, Sakamoto A, Kawakami R, Konishi T, Virmani R, Labhasetwar V, Finn AV. Efficacy and Safety of Dual Paclitaxel and Sirolimus Nanoparticle-Coated Balloon. JACC Basic Transl Sci 2024; 9:774-789. [PMID: 39070273 PMCID: PMC11282887 DOI: 10.1016/j.jacbts.2024.02.002] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/24/2023] [Revised: 02/02/2024] [Accepted: 02/06/2024] [Indexed: 07/30/2024]
Abstract
We evaluated a novel dual active pharmaceutical ingredient (API) drug-coated balloon (DCB), which consists of a coating of nanoparticles encapsulating low-dose paclitaxel (PTX) in combination with sirolimus in a synergistic ratio. Compared to the PTX DCB, the dual API DCB demonstrated similar inhibition of cell proliferation in vitro but at a significantly lower total drug dose (over 13 times lower than sirolimus nanoparticles). Animal experiments demonstrated that the dual API DCB is more effective in inhibiting intimal cell proliferation with insignificant downstream embolic effects and myocardial damage compared to the PTX DCB. These findings indicate that dual API DCBs have a high potential to demonstrate improved clinical outcomes and a greater safety profile than the PTX DCBs.
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Affiliation(s)
- Kenji Kawai
- CVPath Institute, Gaithersburg, Maryland, USA
| | - Mohammed Tanjimur Rahman
- Department of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio, USA
| | - Ryan Nowicki
- Advanced NanoTherapies, Inc, Los Gatos, California, USA
| | | | | | | | | | | | - Vinod Labhasetwar
- Department of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio, USA
| | - Aloke V. Finn
- CVPath Institute, Gaithersburg, Maryland, USA
- University of Maryland, School of Medicine, Baltimore, Maryland, USA
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28
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Lyden SP, Soukas PA, De A, Tedder B, Bowman J, Mustapha JA, Armstrong EJ. DETOUR2 trial outcomes demonstrate clinical utility of percutaneous transmural bypass for the treatment of long segment, complex femoropopliteal disease. J Vasc Surg 2024; 79:1420-1427.e2. [PMID: 38367850 DOI: 10.1016/j.jvs.2024.02.004] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/09/2023] [Revised: 01/29/2024] [Accepted: 02/09/2024] [Indexed: 02/19/2024]
Abstract
OBJECTIVE Percutaneous transmural arterial bypass (PTAB) using the DETOUR system aims to create a percutaneous, endovascular femoropopliteal bypass for the treatment of long segment, complex superficial femoral and proximal popliteal artery disease. The goal of the DETOUR2 study is to investigate the safety and effectiveness of the therapy in comparison with pre-established performance goals. METHODS The DETOUR2 investigational device exemption study is a prospective, single-arm, multicenter, international trial of symptomatic peripheral arterial disease patients (Rutherford classes 3-5) undergoing the DETOUR procedure for long segment (>20 cm) superficial femoral artery disease. Prespecified end points included primary safety (composite of major adverse events) at 30 days, and effectiveness (primary patency defined as freedom from restenosis or clinically driven target lesion revascularization) at 1 year. RESULTS We enrolled 202 patients at 32 sites with 200 treated with the DETOUR system. The mean lesion length was 32.7 cm, of which 96% were chronic total occlusions (CTO) and 70% were severely calcified. Technical success was achieved in 100% of treated patients. The primary safety end point was met with a 30-day freedom from major adverse event rate of 93.0%. The 1-year primary effectiveness end point was met with 72.1% primary patency at 12 months. Primary-assisted and secondary patency were 77.7% and 89.0%, respectively, at 12 months. The 12 month deep venous thrombosis incidence was 4.1% with no pulmonary emboli reported. Venous quality-of-life scores showed no significant changes from baseline. There was a Rutherford improvement of at least one class through 12 months in 97.2% of patients. The mean ankle-brachial index also improved from 0.61 to 0.95 during this period. There were marked improvements in quality-of-life and functional status measures. CONCLUSIONS The DETOUR2 study met both the primary safety and effectiveness end points, demonstrating clinical usefulness of this novel therapeutic strategy in long femoropopliteal lesions.
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Affiliation(s)
- Sean P Lyden
- Department of Vascular Surgery, Heart Vascular and Thoracic Institute, Cleveland Clinic, Cleveland, OH.
| | - Peter A Soukas
- The Miriam Hospital/Brown Medical School, Providence, RI
| | - Ajanta De
- El Camino Hospital, Mountain View, CA
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29
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Choinski KN, Dillard N, Beck AW, Smolock CJ. Appropriate Use Criteria Committees: The professional society role in the development and implementation of Appropriate Use Criteria. Semin Vasc Surg 2024; 37:111-117. [PMID: 39151991 DOI: 10.1053/j.semvascsurg.2024.04.004] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/15/2024] [Revised: 04/21/2024] [Accepted: 04/24/2024] [Indexed: 08/19/2024]
Abstract
Vascular surgeons have the ability to manage and intervene on numerous vascular diseases of both the arterial and venous systems. With the growing number of interventions available as endovascular technology evolves, it is important to determine when a procedure is safely indicated for a vascular surgery patient. Appropriate Use Criteria (AUC) offer synthesized clinical information and practice standards that can aid clinicians in making these management decisions. Professional societies, such as the Society for Vascular Surgery, bring experts in the field together to collaborate and create AUC for various vascular diseases and interventions. It is essential to publish these criteria in peer-reviewed journals, as well as make them available on public websites so the information is available to vascular surgeons and interventionalists from other specialties who also treat patients with vascular disease. Cardiology, interventional radiology, and interventional nephrology are some other specialties that perform procedures for vascular disease, and vascular interventions by nonsurgeon specialists continue to increase. The Society for Vascular Surgery has published AUC on intermittent claudication, carotid disease, and abdominal aneurysm management. These are intended to guide practice, but also have highlighted areas for improvement that would allow for more universal implementation of AUC in vascular patient care across medical specialties. Increased intersocietal participation and perhaps inclusion of government and other payer participation will allow professional society-sponsored AUC to evolve, resulting in coordinated, appropriate care for vascular surgery patients.
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Affiliation(s)
- Krystina N Choinski
- Division of Vascular Surgery, Department of Surgery, The Icahn School of Medicine at Mount Sinai, New York, NY
| | - Nathaniel Dillard
- Division of Vascular Surgery, Department of Surgery, The Icahn School of Medicine at Mount Sinai, New York, NY
| | - Adam W Beck
- Division of Vascular Surgery, Department of Surgery, The Icahn School of Medicine at Mount Sinai, New York, NY
| | - Christopher J Smolock
- Division of Vascular Surgery, Department of Surgery, The Icahn School of Medicine at Mount Sinai, New York, NY.
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Böhme T, Noory E, Beschorner U, Bollenbacher R, Nührenberg T, Rastan A, Westermann D, Zeller T. Matched comparison of uncoated and paclitaxel-coated balloon angioplasty for isolated popliteal lesions excluding bail-out stenting. CARDIOVASCULAR REVASCULARIZATION MEDICINE 2024; 63:54-58. [PMID: 38245433 DOI: 10.1016/j.carrev.2024.01.004] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/05/2023] [Accepted: 01/04/2024] [Indexed: 01/22/2024]
Abstract
OBJECTIVE To evaluate the safety and effectiveness of drug-coated balloon angioplasty (DCB) in isolated popliteal lesions. BACKGROUND The benefit of using DCB in femoropopliteal arteries including the proximal popliteal artery has been demonstrated, but has not yet been evaluated for isolated popliteal lesions. METHODS This retrospective, single-center study includes patients requiring treatment with DCB of isolated popliteal lesions. Two cohorts matched (Plain old balloon angioplasty (POBA) versus DCB) by their baseline and lesion characteristics were compared. Lesions receiving bail-out stents were excluded. Primary endpoint was the 1-year target lesion revascularization (TLR) rate. Secondary endpoints included the procedural success and complication rate, primary patency, changes in Rutherford-Becker class (RBC) and ankle-brachial index (ABI). RESULTS One hundred and seven patients were included in this study. More than one third of the patients had critical limb threatening ischaemia (CLTI) (35 % (POBA) versus 40.4 % (DCB), p = 0.354. The technical success rate of the procedure was 85.1 % (n = 40/47) in the DCB group and 83.3 % (n = 60) in the POBA group (p = 0.510). There were three complications in the POBA group (5.0 %) but none in the DCB group (p = 0.172). After 12 months, in the entire cohort 14 patients (13.1 %) had to undergo a TLR. The TLR-free survival was 81.7 % in the POBA and 93.6 % in the DCB group (p = 0.060). Primary patency rates after POBA and DCB were 65.1 % and 87.5 % at 6 months (p = 0.024), respectively. At 12 months, the patency rates were 71.7 % and 85.1 % (p = 0.076), respectively. For both treatment arms, there was a significant improvement in ABI and RBC compared to baseline. Four patients from the DCB group and two from the POBA group received a minor amputation (p = 0.232). One patient in the DCB group died within 12 months. CONCLUSION After one year the use of DCB is by trend more effective for the treatment of isolated popliteal stenosis compared to POBA. A larger scale prospective study is mandatory.
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Affiliation(s)
- Tanja Böhme
- Department of Cardiology and Angiology, Medical Center, University of Freiburg, Südring 15, 79189 Bad Krozingen, Germany.
| | - Elias Noory
- Department of Cardiology and Angiology, Medical Center, University of Freiburg, Südring 15, 79189 Bad Krozingen, Germany
| | - Ulrich Beschorner
- Department of Cardiology and Angiology, Medical Center, University of Freiburg, Südring 15, 79189 Bad Krozingen, Germany
| | - Roaa Bollenbacher
- Department of Cardiology and Angiology, Medical Center, University of Freiburg, Südring 15, 79189 Bad Krozingen, Germany
| | - Thomas Nührenberg
- Department of Cardiology and Angiology, Medical Center, University of Freiburg, Südring 15, 79189 Bad Krozingen, Germany
| | - Aljoscha Rastan
- Luzerner Kantonsspital, Spitalstrasse, 6000 Luzern, Switzerland
| | - Dirk Westermann
- Department of Cardiology and Angiology, Medical Center, University of Freiburg, Südring 15, 79189 Bad Krozingen, Germany
| | - Thomas Zeller
- Department of Cardiology and Angiology, Medical Center, University of Freiburg, Südring 15, 79189 Bad Krozingen, Germany
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Tan LT, McDermott KM, Hicks CW. Overview and comparison of contemporary Society for Vascular Surgery, American Heart Association/American College of Cardiology, and European Society for Vascular Surgery guidelines for the management of patients with intermittent claudication. Semin Vasc Surg 2024; 37:188-209. [PMID: 39151998 DOI: 10.1053/j.semvascsurg.2024.04.006] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/08/2024] [Revised: 04/18/2024] [Accepted: 04/24/2024] [Indexed: 08/19/2024]
Abstract
Intermittent claudication (IC) is a phenotype of peripheral artery disease that is characterized by pain in the lower extremity muscles during activity that is relieved by rest. Medical management, risk factor control, smoking cessation, and exercise therapy have historically been the mainstays of treatment for IC, but advances in endovascular technology have led to increasing use of peripheral vascular interventions in this patient population. There are meaningful differences in published society guidelines and appropriate use criteria relevant to the management of IC, especially regarding indications for peripheral vascular interventions. The current review aims to highlight similarities and differences between major society recommendations for the management of IC, and to discuss practice trends, disparities, and evidence gaps in the use of peripheral vascular interventions for IC in the context of existing guidelines.
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Affiliation(s)
- Li Ting Tan
- Department of Surgery, The Johns Hopkins Hospital, Johns Hopkins University School of Medicine, 600 North Wolfe Street, Halsted 668, Baltimore, MD 21287
| | - Katherine M McDermott
- Department of Surgery, The Johns Hopkins Hospital, Johns Hopkins University School of Medicine, 600 North Wolfe Street, Halsted 668, Baltimore, MD 21287
| | - Caitlin W Hicks
- Department of Surgery, The Johns Hopkins Hospital, Johns Hopkins University School of Medicine, 600 North Wolfe Street, Halsted 668, Baltimore, MD 21287.
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Jinnouchi H, Sakakura K, Yamamoto K, Taniguchi Y, Fujita H. A unique mechanism of restenosis after drug-coated balloon in peripheral artery: Insight from optical frequency domain imaging. CARDIOVASCULAR REVASCULARIZATION MEDICINE 2024; 62:119-122. [PMID: 38114363 DOI: 10.1016/j.carrev.2023.12.004] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/10/2023] [Revised: 12/05/2023] [Accepted: 12/05/2023] [Indexed: 12/21/2023]
Abstract
Drug-coated balloons (DCBs) have been widely used in endovascular therapy for femoropopliteal arteries with atherosclerotic lesions. Vascular response after DCBs remains unclear. This mini-review proposes a possible mechanism of restenosis after the DCB strategy. Balloon dilatation including DCBs expands the vascular lumen by producing dissections, which is composed of the original vascular lumen and the cavity surrounded by dissected flaps. The cavity surrounded by dissected flaps is eventually replaced with the thrombus in the healing process after balloon dilatation. However, the thrombus may propagate to the expanded vascular lumen through the entry point of the dissection. Subsequently, the thrombus both in the cavity and the expanded lumen would be organized over time. The vascular lumen in the chronic-phase after DCBs may be influenced by the propagated thrombus from the cavity surrounded by dissected flaps.
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Affiliation(s)
- Hiroyuki Jinnouchi
- Division of Cardiovascular Medicine, Saitama Medical Center, Jichi Medical University, Japan.
| | - Kenichi Sakakura
- Division of Cardiovascular Medicine, Saitama Medical Center, Jichi Medical University, Japan
| | - Kei Yamamoto
- Division of Cardiovascular Medicine, Saitama Medical Center, Jichi Medical University, Japan
| | - Yousuke Taniguchi
- Division of Cardiovascular Medicine, Saitama Medical Center, Jichi Medical University, Japan
| | - Hideo Fujita
- Division of Cardiovascular Medicine, Saitama Medical Center, Jichi Medical University, Japan
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Aronow HD, Bonaca MP, Kolluri R, Beckman JA. Recapturing the Team Approach to Vascular Care. Ann Vasc Surg 2024; 101:84-89. [PMID: 38128694 DOI: 10.1016/j.avsg.2023.12.004] [Citation(s) in RCA: 1] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/03/2023] [Accepted: 12/06/2023] [Indexed: 12/23/2023]
Abstract
BACKGROUND The care of the vascular patient remains decentralized rather than coordinated. METHODS We reviewed the current state of practice and published competency and care documents created by vascular professional societies. RESULTS Vascular professional societies routinely and repeatedly endorse both a team approach and the competency of specialists from disparate training backgrounds. The care of the vascular patient does not always reflect these public endorsements. CONCLUSIONS Centering the vascular patient as the mode of organization of care should improve care processes, expertise brought to bear, and outcomes.
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Affiliation(s)
- Herbert D Aronow
- Henry Ford Health, Detroit, MI; Michigan State University College of Human Medicine, East Lansing, MI
| | - Marc P Bonaca
- CPC Clinical Research, Aurora, CO; University of Colorado, Aurora, CO; University of Colorado School of Medicine, Aurora, CO
| | - Raghu Kolluri
- OhioHealth Heart and Vascular, Riverside Methodist Hospital, Columbus, OH
| | - Joshua A Beckman
- Department of Medicine, University of Texas Southwestern Medical Center, Dallas, TX.
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Li J, Varcoe R, Manzi M, Kum S, Iida O, Schmidt A, Shishehbor MH. Below-the-Knee Endovascular Revascularization: A Position Statement. JACC Cardiovasc Interv 2024; 17:589-607. [PMID: 38244007 DOI: 10.1016/j.jcin.2023.11.040] [Citation(s) in RCA: 7] [Impact Index Per Article: 7.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/24/2022] [Revised: 10/30/2023] [Accepted: 11/28/2023] [Indexed: 01/22/2024]
Abstract
Patients with chronic limb-threatening ischemia, the terminal stage of peripheral artery disease, are frequently afflicted by below-the-knee disease. Although all patients should receive guideline-directed medical therapy, restoration of inline flow is oftentimes necessary to avoid limb loss. Proper patient selection and proficiency in endovascular techniques for below-the-knee revascularization are intended to prevent major amputation and promote wound healing. This review, a consensus among an international panel of experienced operators, provides guidance on these challenges from an endovascular perspective and offers techniques to navigate this complex disease process.
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Affiliation(s)
- Jun Li
- University Hospitals Harrington Heart and Vascular Institute, Cleveland, Ohio, USA; Case Western Reserve University School of Medicine, Cleveland, Ohio, USA
| | - Ramon Varcoe
- Prince of Wales Hospital, Sydney, New South Wales, Australia; Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia
| | - Marco Manzi
- Interventional Radiology Unit, Foot and Ankle Clinic, Policlinico Abano Terme, Abano Terme, Italy
| | - Steven Kum
- Department of Surgery, Changi General Hospital, Singapore
| | - Osamu Iida
- Kasai Rosai Hospital Cardiovascular Center, Amagasaki, Japan
| | - Andrej Schmidt
- Division of Angiology, Department of Internal Medicine, Neurology and Dermatology, University Hospital Leipzig, Leipzig, Germany
| | - Mehdi H Shishehbor
- University Hospitals Harrington Heart and Vascular Institute, Cleveland, Ohio, USA; Case Western Reserve University School of Medicine, Cleveland, Ohio, USA.
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35
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Spiliopoulos S. Interventions for Pedal Disease. MASTERING ENDOVASCULAR TECHNIQUES 2024:173-179. [DOI: 10.1007/978-3-031-42735-0_18] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 01/07/2025]
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Hicks CW. When will we finally accept that early interventions for claudication are bad news? J Vasc Surg 2024; 79:167-168. [PMID: 38129073 DOI: 10.1016/j.jvs.2023.08.114] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/11/2023] [Accepted: 08/15/2023] [Indexed: 12/23/2023]
Affiliation(s)
- Caitlin W Hicks
- Division of Vascular Surgery and Endovascular Surgery, Johns Hopkins University School of Medicine, Baltimore, MD
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Pan D, Guo J, Su Z, Meng W, Wang J, Guo J, Gu Y. Efficacy and Safety of Atherectomy Combined With Balloon Angioplasty vs Balloon Angioplasty Alone in Patients With Femoro-Popliteal Lesions: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Endovasc Ther 2023:15266028231215354. [PMID: 38049942 DOI: 10.1177/15266028231215354] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/06/2023]
Abstract
BACKGROUND Balloon angioplasty (BA), including drug-coated balloons (DCBs) and percutaneous transluminal angioplasty (PTA), has traditionally been used to treat femoral-popliteal lesions. However, in recent years, atherectomy (ATH) has been proposed as a complementary approach. To assess the effectiveness of ATH compared with BA alone in patients with femoral-popliteal artery lesions, we conducted a systematic review and meta-analysis of randomized controlled trials (RCTs). METHODS We included RCTs that focused on patients with femoral-popliteal artery lesions and reported data on the use of ATH and BA therapy. Two reviewers conducted a literature search, refined the data, and assessed the risk of bias. RESULTS We included a total of 6 RCTs involving 399 patients with femoral-popliteal artery lesions. The use of ATH in combination with BA appeared to improve the patency rate at 12 months (odds ratio [OR]=2.04, 95% confidence interval [CI]=1.14-3.62). In addition, ATH with BA was associated with lower major amputation rates (MD=2.01, 95% CI=0.06-0.77, p=0.02) and a decreased likelihood of bailout stenting (OR=0.07, 95% CI=0.02-0.25, p=0.001). However, there were no statistically significant differences between the groups in terms of target lesion revascularization (TLR) at 12 months, major adverse cardiovascular events (MACEs), and distal embolization events. In addition, we performed subgroup analysis for different ATH devices and BA types. CONCLUSIONS Based on this meta-analysis, it can be concluded that the use of ATH in combination with BA is a safe and effective method for treating femoral-popliteal artery lesions. In addition, the patency rate at 1 year is superior to treatment with BA alone. Atherectomy also reduces the likelihood of amputation and bailout stenting. Clinicians should consider these findings when designing future RCTs and developing clinical practice guidelines. CLINICAL IMPACT This meta-analysis summarises a number of existing studies to advance understanding of the atherectomy devices and to reveal its potential. This new technique, when compared with drug coated balloon, shows the possibility of obtaining better clinical outcomes in femoro-popliteal lesions than drug-coated balloon alone, such as higher 12-month primary patency rates as shown in some studies. Currently, it is important to consider the appropriate technology applicable for individualised treatment. atherectomy devices seem to provide clinicians with additional options in clinical practice and to benefit patients in the future. This requires more high quality studies to explore the role and benefits of atherectomy devices in femoro-popliteal lesions.
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Affiliation(s)
- Dikang Pan
- Department of Vascular Surgery, Xuanwu Hospital, Capital Medical University, Beijing, China
| | - Julong Guo
- Department of Vascular Surgery, Xuanwu Hospital, Capital Medical University, Beijing, China
| | - Zhixiang Su
- Department of Vascular Surgery, Xuanwu Hospital, Capital Medical University, Beijing, China
| | - Wenzhuo Meng
- Department of Vascular Surgery, Xuanwu Hospital, Capital Medical University, Beijing, China
| | - Jingyu Wang
- Renal Division, Peking University First Hospital, Beijing, China
| | - Jianming Guo
- Department of Vascular Surgery, Xuanwu Hospital, Capital Medical University, Beijing, China
| | - Yongquan Gu
- Department of Vascular Surgery, Xuanwu Hospital, Capital Medical University, Beijing, China
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Winchester DE, Maron DJ, Blankstein R, Chang IC, Kirtane AJ, Kwong RY, Pellikka PA, Prutkin JM, Russell R, Sandhu AT. ACC/AHA/ASE/ASNC/ASPC/HFSA/HRS/SCAI/SCCT/SCMR/STS 2023 Multimodality Appropriate Use Criteria for the Detection and Risk Assessment of Chronic Coronary Disease. J Cardiovasc Magn Reson 2023; 25:58. [PMID: 37858155 PMCID: PMC10585920 DOI: 10.1186/s12968-023-00958-5] [Citation(s) in RCA: 4] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/01/2023] [Accepted: 08/11/2023] [Indexed: 10/21/2023] Open
Abstract
The American College of Cardiology (ACC) Foundation, along with key specialty and subspecialty societies, conducted an appropriate use review of stress testing and anatomic diagnostic procedures for risk assessment and evaluation of known or suspected chronic coronary disease (CCD), formerly referred to as stable ischemic heart disease (SIHD). This document reflects an updating of the prior Appropriate Use Criteria (AUC) published for radionuclide imaging, stress echocardiography (echo), calcium scoring, coronary computed tomography angiography (CCTA), stress cardiac magnetic resonance (CMR), and invasive coronary angiography for SIHD. This is in keeping with the commitment to revise and refine the AUC on a frequent basis. As with the prior version of this document, rating of test modalities is provided side-by-side for a given clinical scenario. These ratings are explicitly not considered competitive rankings due to the limited availability of comparative evidence, patient variability, and the range of capabilities available in any given local setting1-4.This version of the AUC for CCD is a focused update of the prior version of the AUC for SIHD4. Key changes beyond the updated ratings based on new evidence include the following: 1. Clinical scenarios related to preoperative testing were removed and will be incorporated into another AUC document under development. 2. Some clinical scenarios and tables were removed in an effort to simplify the selection of clinical scenarios. Additionally, the flowchart of tables has been reorganized, and all clinical scenario tables can now be reached by answering a limited number of clinical questions about the patient, starting with the patient's symptom status. 3. Several clinical scenarios have been revised to incorporate changes in other documents such as pretest probability assessment, atherosclerotic cardiovascular disease (ASCVD) risk assessment, syncope, and others. ASCVD risk factors that are not accounted for in contemporary risk calculators have been added as modifiers to certain clinical scenarios. The 64 clinical scenarios rated in this document are limited to the detection and risk assessment of CCD and were drawn from common applications or anticipated uses, as well as from current clinical practice guidelines.5 These clinical scenarios do not specifically address patients having acute chest pain episodes. They may, however, be applicable in the inpatient setting if the patient is not having an acute coronary syndrome and warrants evaluation for CCD.Using standardized methodology, clinical scenarios were developed to describe common patient encounters in clinical practice focused on common applications and anticipated uses of testing for CCD. Where appropriate, the scenarios were developed on the basis of the most current ACC/American Heart Association guidelines. A separate, independent rating panel scored the clinical scenarios in this document on a scale of 1 to 9, following a modified Delphi process consistent with the recently updated AUC development methodology. Scores of 7 to 9 indicate that a modality is considered appropriate for the clinical scenario presented, midrange scores of 4 to 6 indicate that a modality may be appropriate for the clinical scenario, and scores of 1 to 3 indicate that a modality is rarely appropriate.
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Affiliation(s)
| | | | - Ron Blankstein
- Society of Cardiovascular Computed Tomography, Washington, USA
| | | | - Ajay J Kirtane
- Society for Cardiovascular Angiography and Interventions, Washington, USA
| | - Raymond Y Kwong
- Society for Cardiovascular Magnetic Resonance, Washington, USA
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Tobita K, Takahara M, Iida O, Soga Y, Yamaoka T, Ichihashi S, Saito S. Clinical Impact of Additional Cilostazol Treatment on Restenosis Risk following Heparin-Bonded Stent Graft Implantation: Sub-Analysis from the Viabahn Stent-Graft Placement for Femoropopliteal Diseases Requiring Endovascular Therapy (VANQUISH) Study. J Atheroscler Thromb 2023; 30:1461-1470. [PMID: 36725018 PMCID: PMC10564643 DOI: 10.5551/jat.63874] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/07/2022] [Accepted: 12/21/2022] [Indexed: 02/03/2023] Open
Abstract
AIM The present study investigated the effects of additional cilostazol administration on the 12-month risk of restenosis after femoropopliteal heparin-bonded stent graft implantation. METHODS This study was a sub-analysis of the Viabahn stent graft placement for femoropopliteal disease reQUIring endovaScular tHerapy (VANQUISH) study, which was a prospective multicenter study investigating patients who received Viabahn stent graft (W.L. Gore & Associates, Flagstaff, AZ, USA) and dual-antiplatelet therapy with aspirin and a thienopyridine. The comparison of clinical outcomes between subgroups with and without cilostazol treatment were performed using the propensity score-matching method to minimize the intergroup differences in baseline characteristics. RESULTS Cilostazol-treated patients had a lower 12-month proportion of restenosis than cilostazol-free patients (8.2% vs 27.3%). The odds ratio of cilostazol for the 12-month restenosis was 0.27 [95% CI, 0.08 to 0.97] (p=0.045). Furthermore, the cumulative incidence rates of surgical reconstruction, target lesion revascularization and acute thrombotic occlusion (p values by the log-rank test) were 2.6% versus 1.8% (P=0.43), 5.3% versus 20.5% (P=0.067), and 0.0% versus 11.8% (P=0.0499), respectively. The rates of surgical reconstruction and target lesion revascularization (TLR) were not significantly different between both groups. CONCLUSIONS Our study revealed the clinical impact of additional cilostazol treatment on the risk of restenosis and acute thrombotic occlusion following heparin-bonded stent graft implantation, while TLR and surgical reconstruction were not significantly different.
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Affiliation(s)
- Kazuki Tobita
- Department of Cardiology, Shonan Kamakura General Hospital, Kanagawa, Japan
| | - Mitsuyoshi Takahara
- Department of Diabetes Care Medicine and Department of Metabolic Medicine, Osaka University Graduate School of Medicine, Osaka, Japan
| | - Osamu Iida
- Cardiovascular Center, Kansai Rosai Hospital, Hyogo, Japan
| | - Yoshimitsu Soga
- Department of Cardiology, Kokura Memorial Hospital, Fukuoka, Japan
| | - Terutoshi Yamaoka
- Department of Vascular Surgery, Matsuyama Red Cross Hospital, Ehime, Japan
| | | | - Shigeru Saito
- Department of Cardiology, Shonan Kamakura General Hospital, Kanagawa, Japan
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Cheon JE, Kim HJ. Recurrent flash pulmonary edema in unilateral renal artery stenosis with contralateral kidney shrinkage: A case report. Medicine (Baltimore) 2023; 102:e35228. [PMID: 37747008 PMCID: PMC10519504 DOI: 10.1097/md.0000000000035228] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/29/2023] [Revised: 08/06/2023] [Accepted: 08/24/2023] [Indexed: 09/26/2023] Open
Abstract
RATIONALE Flash pulmonary edema is a critical medical condition characterized by sudden and severe fluid accumulation in the lungs, which poses an immediate and life-threatening emergency. This can arise from a variety of underlying causes. This manuscript presents a case of recurrent pulmonary edema that was successfully managed through the insertion of a renal artery stent. PATIENT CONCERNS A 78-year-old woman visited the emergency room with recurrent acute dyspnea. Computed tomography renal angiography revealed renal artery stenosis of a single-functioning kidney. DIAGNOSES Flash pulmonary edema caused by renal artery stenosis of a functioning single kidney. INTERVENTIONS Percutaneous transluminal angioplasty and stenting were performed for the renal artery stenosis. OUTCOMES The patient's kidney function rapidly improved, and she has been free of flash pulmonary edema for 2 years. LESSONS Flash pulmonary edema can have various causes and can immediately be a life-threatening emergency. However, it can be treated with percutaneous revascularization if it is caused by renal artery stenosis. This case report reinforces the importance of accurate and immediate diagnosis when dealing with flash pulmonary edema. This case emphasizes the potential therapeutic benefit of renal artery stenting in the management of flash pulmonary edema caused by renal artery stenosis in patients with a single-functioning kidney.
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Affiliation(s)
- Ji Eun Cheon
- Department of Internal Medicine, Pusan National University Hospital, Busan, Korea
| | - Hyo Jin Kim
- Department of Internal Medicine, Pusan National University Hospital, Busan, Korea
- Department of Internal Medicine, Pusan National University School of Medicine, Yangsan, Korea
- Biomedical Research Institute, Pusan National University Hospital, Busan, Korea
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Parikh SA, Ingrassia JJ, Finn MT. Femoropopliteal Arterial Interventions in the Claudicant. ENDOVASCULAR INTERVENTIONS 2023:108-137. [DOI: 10.1002/9781119467779.ch9] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 01/07/2025]
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Weaver ML, Neal D, Columbo JA, Holscher CM, Sorber RA, Hicks CW, Stone DH, Clouse WD, Scali ST. Market competition influences practice patterns in management of patients with intermittent claudication in the vascular quality initiative. J Vasc Surg 2023; 78:727-736.e3. [PMID: 37141948 PMCID: PMC10699768 DOI: 10.1016/j.jvs.2023.04.032] [Citation(s) in RCA: 11] [Impact Index Per Article: 5.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/13/2023] [Revised: 04/06/2023] [Accepted: 04/24/2023] [Indexed: 05/06/2023]
Abstract
OBJECTIVE The Society for Vascular Surgery (SVS) clinical practice guidelines recommend best medical therapy (BMT) as first-line therapy before offering revascularization to patients with intermittent claudication (IC). Notably, atherectomy and tibial-level interventions are generally discouraged for management of IC; however, high regional market competition may incentivize physicians to treat patients outside the scope of guideline-directed therapy. Therefore, we sought to determine the association between regional market competition and endovascular treatment of patients with IC. METHODS We examined patients with IC undergoing index endovascular peripheral vascular interventions (PVI) in the SVS Vascular Quality Initiative from 2010 to 2022. We assigned the Herfindahl-Hirschman Index as a measure of regional market competition and stratified centers into very high competition (VHC), high competition, moderate competition, and low competition cohorts. We defined BMT as preoperative documentation of being on antiplatelet medication, statin, nonsmoking status, and a recorded ankle-brachial index. We used logistic regression to evaluate the association of market competition with patient and procedural characteristics. A sensitivity analysis was performed in patients with isolated femoropopliteal disease matched by the TransAtlantic InterSociety classification of disease severity. RESULTS There were 24,669 PVIs that met the inclusion criteria. Patients with IC undergoing PVI were more likely to be on BMT when treated in higher market competition centers (odds ratio [OR], 1.07 per increase in competition quartile; 95% confidence interval [CI], 1.04-1.11; P < .0001). The probability of undergoing aortoiliac interventions decreased with increasing competition (OR, 0.84; 95% CI, 0.81-0.87; P < .0001), but there were higher odds of receiving tibial (OR, 1.40; 95% CI, 1.30-1.50; P < .0001) and multilevel interventions in VHC vs low competition centers (femoral + tibial OR, 1.10; 95% CI, 1.03-1.14; P = .001). Stenting decreased as competition increased (OR, 0.89; 95% CI, 0.87-0.92; P < .0001), whereas exposure to atherectomy increased with higher market competition (OR, 1.15; 95% CI, 1.11-1.19; P < .0001). When assessing patients undergoing single-artery femoropopliteal intervention for TransAtlantic InterSociety A or B lesions to account for disease severity, the odds of undergoing either balloon angioplasty (OR, 0.72; 95% CI, 0.625-0.840; P < .0001) or stenting only (OR, 0.84; 95% CI, 0.727-0.966; P < .0001) were lower in VHC centers. Similarly, the likelihood of receiving atherectomy remained significantly higher in VHC centers (OR, 1.6; 95% CI, 1.36-1.84; P < .0001). CONCLUSIONS High market competition was associated with more procedures among patients with claudication that are not consistent with guideline-directed therapy per the SVS clinical practice guidelines, including atherectomy and tibial-level interventions. This analysis demonstrates the susceptibility of care delivery to regional market competition and signifies a novel and undefined driver of PVI variation among patients with claudication.
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Affiliation(s)
- M Libby Weaver
- Division of Vascular and Endovascular Surgery, University of Virginia Health System, Charlottesville, VA.
| | - Dan Neal
- Department of Surgery, University of Florida, Gainesville, FL
| | - Jesse A Columbo
- Section of Vascular Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH
| | - Courtenay M Holscher
- Division of Vascular Surgery and Endovascular Therapy, Johns Hopkins University School of Medicine, Baltimore, MD
| | - Rebecca A Sorber
- Division of Vascular Surgery and Endovascular Therapy, Johns Hopkins University School of Medicine, Baltimore, MD
| | - Caitlin W Hicks
- Division of Vascular Surgery and Endovascular Therapy, Johns Hopkins University School of Medicine, Baltimore, MD
| | - David H Stone
- Section of Vascular Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH
| | - W Darrin Clouse
- Division of Vascular and Endovascular Surgery, University of Virginia Health System, Charlottesville, VA
| | - Salvatore T Scali
- Division of Vascular Surgery and Endovascular Therapy, University of Florida, Gainesville, FL
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Bass TA, Abbott JD, Mahmud E, Parikh SA, Aboulhosn J, Ashwath ML, Baranowski B, Bergersen L, Chaudry HI, Coylewright M, Denktas AE, Gupta K, Gutierrez JA, Haft J, Hawkins BM, Herrmann HC, Kapur NK, Kilic S, Lesser J, Lin CH, Mendirichaga R, Nkomo VT, Park LG, Phoubandith DR, Quader N, Rich MW, Rosenfield K, Sabri SS, Shames ML, Shernan SK, Skelding KA, Tamis-Holland J, Thourani VH, Tremmel JA, Uretsky S, Wageman J, Welt F, Whisenant BK, White CJ, Yong CM, Mendes LA, Arrighi JA, Breinholt JP, Day J, Dec GW, Denktas AE, Drajpuch D, Faza N, Francis SA, Hahn RT, Housholder-Hughes SD, Khan SS, Kondapaneni MD, Lee KS, Lin CH, Hussain Mahar J, McConnaughey S, Niazi K, Pearson DD, Punnoose LR, Reejhsinghani RS, Ryan T, Silvestry FE, Solomon MA, Spicer RL, Weissman G, Werns SW. 2023 ACC/AHA/SCAI advanced training statement on interventional cardiology (coronary, peripheral vascular, and structural heart interventions): A report of the ACC Competency Management Committee. J Thorac Cardiovasc Surg 2023; 166:e73-e123. [PMID: 37269254 DOI: 10.1016/j.jtcvs.2023.04.024] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 06/05/2023]
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O'Banion LA, Saadi S, Hasan B, Nayfeh T, Simons JP, Murad MH, Woo K. Lack of patient-centered evaluation of outcomes in intermittent claudication literature. J Vasc Surg 2023; 78:828-836. [PMID: 37044317 DOI: 10.1016/j.jvs.2023.03.497] [Citation(s) in RCA: 4] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/05/2023] [Revised: 02/06/2023] [Accepted: 03/23/2023] [Indexed: 04/14/2023]
Abstract
BACKGROUND Peripheral arterial disease, characterized as arterial atherosclerotic disease, can lead to insufficient flow in the lower extremities and ischemia, with the most common clinical manifestation being intermittent claudication (IC). In 2022, the Society for Vascular Surgery (SVS) developed appropriate use criteria for the management of IC that used this systematic review as a source of evidence. The objective of this study is to synthesize the findings of the systematic review and identify evidence gaps. METHODS A comprehensive search of literature databases including MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and Scopus was conducted from January 1, 2000, to November 30, 2022. Noncomparative and comparative observational studies and randomized controlled trials were included. Included studies evaluated exercise therapy, endovascular or open revascularization for the treatment of IC. Outcomes of interest (freedom from major adverse limb event, health-related quality of life, and walking distance) were compared in various subgroups (age, sex, diabetes, smoking status, anatomical location of disease, and optimal medical therapy). RESULTS Twenty-six studies reported the outcomes of interest for the evidence map. The general conclusions of the studies that reported freedom from major adverse limb events were that reintervention rates for endovascular therapy at ≥2 years were >20%, major amputation rates were often not reported, and, after endovascular therapy, the 1-month mortality was low (<2%). Quality of life and walking distance data were sparse, limited to only endovascular intervention, and insufficient to make any strong conclusions. CONCLUSIONS IC in patients with peripheral arterial disease poses a significant socioeconomic and health care burden. Major, consequential gaps exist in the IC literature with respect to the assessment of patient reported outcome measures, standardized measures of walking distance and the comparative effectiveness of initial exercise therapy vs invasive intervention. The evidence gaps identified by the Society for Vascular Surgery appropriate use criteria on IC systematic review serve as a guide for future research efforts to optimize care for this patient population.
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Affiliation(s)
- Leigh Ann O'Banion
- Division of Vascular Surgery, Department of Surgery, University of California San Francisco-Fresno, Fresno, CA. leighann.o'
| | - Samer Saadi
- Evidence-Based Practice Center, Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN
| | - Bashar Hasan
- Evidence-Based Practice Center, Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN
| | - Tarek Nayfeh
- Evidence-Based Practice Center, Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN
| | - Jessica P Simons
- Division of Vascular and Endovascular Surgery, University of Massachusetts Chan Medical School, Worcester, MA
| | - Mohammad H Murad
- Evidence-Based Practice Center, Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN
| | - Karen Woo
- Division of Vascular Surgery, Department of Surgery, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA
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Raja A, Secemsky EA. Late Mortality and Paclitaxel-Coated Devices: Has the Controversy Finally Come to an End? JOURNAL OF THE SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY & INTERVENTIONS 2023; 2:100981. [PMID: 39131639 PMCID: PMC11308809 DOI: 10.1016/j.jscai.2023.100981] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Key Words] [Grants] [Track Full Text] [Figures] [Subscribe] [Scholar Register] [Received: 04/06/2023] [Accepted: 04/10/2023] [Indexed: 08/13/2024]
Affiliation(s)
- Aishwarya Raja
- Department of Medicine, Columbia University Medical Center, New York, New York
| | - Eric A. Secemsky
- Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts
- Division of Cardiology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts
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Modrall JG, Jeon-Slaughter H, Ramanan B, Tsai S, Miller RT, Hastings JL. Predicting renal function response to renal artery stenting. J Vasc Surg 2023; 78:102-110.e1. [PMID: 36868330 DOI: 10.1016/j.jvs.2023.02.010] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/20/2023] [Revised: 02/13/2023] [Accepted: 02/15/2023] [Indexed: 03/05/2023]
Abstract
OBJECTIVE The Cardiovascular Outcomes in Renal Atherosclerotic Lesions Trial found no benefit of renal artery stenting (RAS) over medical therapy, although it was underpowered to detect a benefit among patients with chronic kidney disease (CKD). A post hoc analysis demonstrated improved event-free survival after RAS for patients whose renal function improved by 20% or more. A significant obstacle to achieving this benefit is the inability to predict which patients' renal function will improve from RAS. The objectives of the current study were to identify predictors of renal function response to RAS. METHODS The Veteran Affairs Corporate Data Warehouse was queried for patients who underwent RAS between 2000 and 2021. The primary outcome was improvement in renal function (estimated glomerular filtration rate [eGFR]) after stenting. Patients were categorized as responders if the eGFR at 30 days or greater after stenting increased by 20% or more compared with before stenting. All others were nonresponders. RESULTS The study cohort included 695 patients with a median follow-up of 7.1 years (interquartile range, 3.7-11.6 years). Based on postoperative change in eGFR, 202 stented patients (29.1%) were responders, and the remainder (n = 493 [70.9%]) were nonresponders. Before RAS, responders had a significantly higher mean serum creatinine, lower mean eGFR, and higher rate of decline of preoperative GFR in the months before stenting. After stenting, responders had a 26.1% increase in eGFR, compared with before stenting (P < .0001), which remained stable during follow-up. In contrast, nonresponders had a progressive 5.5% decrease in eGFR after stenting. Logistic regression analysis identified three predictors of renal function response to stenting: (1) diabetes (odds ratio [OR], 0.64; 95% confidence interval [CI], 0.44-0.91; P = .013), (2) CKD stages 3b or 4 (OR, 1.80; 95% CI, 1.26-2.57; P = .001), and (3) rate of decline in preoperative eGFR per week before stenting (OR, 1.21; 95% CI, 1.05-1.39; P = .008). CKD stages 3b and 4 and the rate of decline in preoperative eGFR are positive predictors of renal function response to stenting, whereas diabetes is a negative predictor. CONCLUSIONS Based on our data, patients in CKD stages 3b and 4 (eGFR 15-44 mL/min/1.73 m2) are the only subgroups with a significant probability of improved renal function after RAS. The rate of decline of preoperative eGFR over the months before stenting is a powerful discriminator of patients who are most likely to benefit from RAS. Specifically, patients with a more rapid decrease in eGFR before stenting have a significantly greater probability of improved renal function with RAS. In contrast, diabetes is a negative predictor of improved renal function, so interventionalists should be circumspect about RAS in diabetic patients.
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Affiliation(s)
- J Gregory Modrall
- Surgical Service, Dallas Veterans Affairs Medical Center, Dallas, TX; Division of Vascular and Endovascular Surgery, Department of Surgery, University of Texas Southwestern Medical Center, Dallas, TX.
| | | | - Bala Ramanan
- Surgical Service, Dallas Veterans Affairs Medical Center, Dallas, TX; Division of Vascular and Endovascular Surgery, Department of Surgery, University of Texas Southwestern Medical Center, Dallas, TX
| | - Shirling Tsai
- Surgical Service, Dallas Veterans Affairs Medical Center, Dallas, TX; Division of Vascular and Endovascular Surgery, Department of Surgery, University of Texas Southwestern Medical Center, Dallas, TX
| | - R Tyler Miller
- Medicine Service, Dallas Veterans Affairs Medical Center, Dallas, TX; Division of Nephrology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX
| | - Jeffrey L Hastings
- Medicine Service, Dallas Veterans Affairs Medical Center, Dallas, TX; Division of Cardiology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX
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Winchester DE, Maron DJ, Blankstein R, Chang IC, Kirtane AJ, Kwong RY, Pellikka PA, Prutkin JM, Russell R, Sandhu AT. ACC/AHA/ASE/ASNC/ASPC/HFSA/HRS/SCAI/SCCT/SCMR/STS 2023 Multimodality Appropriate Use Criteria for the Detection and Risk Assessment of Chronic Coronary Disease. J Am Coll Cardiol 2023; 81:2445-2467. [PMID: 37245131 DOI: 10.1016/j.jacc.2023.03.410] [Citation(s) in RCA: 38] [Impact Index Per Article: 19.0] [Reference Citation Analysis] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 05/29/2023]
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Bass TA, Abbott JD, Mahmud E, Parikh SA, Aboulhosn J, Ashwath ML, Baranowski B, Bergersen L, Chaudry HI, Coylewright M, Denktas AE, Gupta K, Gutierrez JA, Haft J, Hawkins BM, Herrmann HC, Kapur NK, Kilic S, Lesser J, Lin CH, Mendirichaga R, Nkomo VT, Park LG, Phoubandith DR, Quader N, Rich MW, Rosenfield K, Sabri SS, Shames ML, Shernan SK, Skelding KA, Tamis-Holland J, Thourani VH, Tremmel JA, Uretsky S, Wageman J, Welt F, Whisenant BK, White CJ, Yong CM. 2023 ACC/AHA/SCAI Advanced Training Statement on Interventional Cardiology (Coronary, Peripheral Vascular, and Structural Heart Interventions): A Report of the ACC Competency Management Committee. JACC Cardiovasc Interv 2023; 16:1239-1291. [PMID: 37115166 DOI: 10.1016/j.jcin.2023.04.011] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 04/29/2023]
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Bass TA, Abbott JD, Mahmud E, Parikh SA, Aboulhosn J, Ashwath ML, Baranowski B, Bergersen L, Chaudry HI, Coylewright M, Denktas AE, Gupta K, Gutierrez JA, Haft J, Hawkins BM, Herrmann HC, Kapur NK, Kilic S, Lesser J, Lin CH, Mendirichaga R, Nkomo VT, Park LG, Phoubandith DR, Quader N, Rich MW, Rosenfield K, Sabri SS, Shames ML, Shernan SK, Skelding KA, Tamis-Holland J, Thourani VH, Tremmel JA, Uretsky S, Wageman J, Welt F, Whisenant BK, White CJ, Yong CM. 2023 ACC/AHA/SCAI Advanced Training Statement on Interventional Cardiology (Coronary, Peripheral Vascular, and Structural Heart Interventions): A Report of the ACC Competency Management Committee. J Am Coll Cardiol 2023; 81:1386-1438. [PMID: 36801119 DOI: 10.1016/j.jacc.2022.11.002] [Citation(s) in RCA: 4] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/18/2023]
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Bass TA, Abbott JD, Mahmud E, Parikh SA, Aboulhosn J, Ashwath ML, Baranowski B, Bergersen L, Chaudry HI, Coylewright M, Denktas AE, Gupta K, Gutierrez JA, Haft J, Hawkins BM, Herrmann HC, Kapur NK, Kilic S, Lesser J, Huie LC, Mendirichaga R, Nkomo VT, Park LG, Phoubandith DR, Quader N, Rich MW, Rosenfield K, Sabri SS, Shames ML, Shernan SK, Skelding KA, Tamis-Holland J, Thourani VH, Tremmel JA, Uretsky S, Wageman J, Welt F, Whisenant BK, White CJ, Yong CM. 2023 ACC/AHA/SCAI Advanced Training Statement on Interventional Cardiology (Coronary, Peripheral Vascular, and Structural Heart Interventions): A Report of the ACC Competency Management Committee. Circ Cardiovasc Interv 2023; 16:e000088. [PMID: 36795800 DOI: 10.1161/hcv.0000000000000088] [Citation(s) in RCA: 5] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/18/2023]
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