Clinical Journal of the American Society of Nephrology, 2018
BackgroundRestenosis remains a problem in hemodialysis access interventions. Paclitaxel-coated ba... more BackgroundRestenosis remains a problem in hemodialysis access interventions. Paclitaxel-coated balloons have shown promise in reducing access-related restenosis in small trials. The primary hypotheses for our multicenter trial were superior effectiveness at 180 days and noninferior safety at 30 days of a drug-coated balloon compared with conventional angioplasty for treatment of dysfunctional arteriovenous fistulas.Design, setting, participants, & measurementsThis randomized trial enrolled 285 patients with dysfunctional arteriovenous fistulas at 23 centers. Grafts, central venous stenoses, thrombosed fistulas, and immature fistulas were excluded. All patients received angioplasty of the lesion responsible for access dysfunction. After successful angioplasty (≤30% residual stenosis), lesions were treated with either a paclitaxel-coated balloon or an uncoated control balloon of similar design to the drug-coated balloon. Access function during follow-up was determined per centers’ usu...
Journal of vascular and interventional radiology : JVIR, Apr 1, 2018
for the Central Vein Work Group and the Technology Assessment Committee ABBREVIATIONS AV ¼ arteri... more for the Central Vein Work Group and the Technology Assessment Committee ABBREVIATIONS AV ¼ arteriovenous, BCV ¼ brachiocephalic vein, CDE ¼ common data element, CVWG ¼ Central Vein Work Group, IJV ¼ internal jugular vein, IVC ¼ inferior vena cava, SCV ¼ subclavian vein, SVC ¼ superior vena cava, TCVO ¼ thoracic central vein obstruction PREAMBLE This effort to produce a thoracic central vein obstruction (TCVO) reporting document arose from informal discussions at meetings of several professional societies. These societies share a common interest in promoting responsible and sustainable vascular access through education, research, and clinical practice initiatives. TCVO is not only a major clinical problem that impacts vascular access but is also encountered in patients with end-stage renal disease, cancer, infection, parenteral nutrition requirements, cardiac dysrhythmias, and many other conditions. It was recognized that a multidisciplinary coalition would be required to develop a useful comprehensive reporting system acceptable to all major stakeholders in this domain. Participants and Methods This multidisciplinary coalition, called the Central Vein Work Group (CVWG), consists of clinicians and basic scientists from academic and private practices. The clinical specialties of interventional radiology, nephrology, vascular surgery, transplant surgery, pediatrics, hematology/ oncology, cardiology, and clinical anatomy were represented. This document was drafted during a series of Web-based meetings and conference calls. After an organizational outline was established, individual topics were discussed until resolved. Whenever possible, statements contained in this document are based on peer-reviewed literature. All included references are relevant to current practice and free from relationships with industry or other sources of bias.
Time for primary review: 46 days Aims Chronic kidney disease (CKD) is a powerful independent risk... more Time for primary review: 46 days Aims Chronic kidney disease (CKD) is a powerful independent risk factor for cardiovascular events, including vein graft failure. Because CKD impairs the clearance of small proteins, we tested the hypothesis that CKD exacerbates vein graft disease by elevating serum levels of critical cytokines that promote vein graft neointimal hyperplasia.
Supplemental material, sj-pdf-1-jva-10.1177_11297298211018295 for Patient-reported outcomes in he... more Supplemental material, sj-pdf-1-jva-10.1177_11297298211018295 for Patient-reported outcomes in hemodialysis vascular access: A call to action by Karen Woo, Robert Fuld, Amanda Grandinetti, Jeffrey Lawson, Terry Litchfield, Mark Ohan, John Devin Peipert, Matthew B Rivara, Glenda Roberts, Prabir Roy-Chaudhury, Margo Underwood and Robert J Nordyke in The Journal of Vascular Access
Thrombin is a common hemostatic drug used in surgical practice for over 100 years because of its ... more Thrombin is a common hemostatic drug used in surgical practice for over 100 years because of its simplicity and efficacy. Thrombin converts fibrinogen to fibrin, activates platelets, and induces vascular contraction. It is available in multiple forms, including human thrombin, bovine thrombin, and, most recently, human recombinant thrombin. Over 100 case reports of adverse reactions to bovine thrombin include hemorrhage, thrombosis, and substantial immune reaction when used on cardiovascular surgery patients. Approximately 30% of patients exposed to bovine thrombin develop cross-reacting antibodies. Thirty percent of patients with anticlotting factor antibodies develop abnormal coagulation that can be detected by prothrombin time, partial thromboplastin time, or thrombin time, which makes anticoagulation monitoring difficult. Patients with multiple elevated antibodies prior to surgery are also more likely to sustain adverse events. Animal studies confirm these immunological response...
While access-related dysfunction is a clear driver of clinical outcomes and costs, the full impac... more While access-related dysfunction is a clear driver of clinical outcomes and costs, the full impact of vascular access dysfunction on patient experience and quality of life is not fully characterized in the literature. One way to more comprehensively characterize the patient experience from the patient perspective is through patient reported outcomes (PROs). However, the limited implementation of PROs in clinical trials, patient registries, quality measurement, and other research settings has significantly constrained the patient voice in evaluation of vascular access outcomes and vascular access decision-making. To address these issues, the Kidney Health Initiative, a public-private partnership between the American Society of Nephrology and the U.S. Food and Drug Administration, assembled an interdisciplinary workgroup to enhance uptake of access-related PROs with the aims of: (1) reviewing the domains of HRQOL that are affected by vascular access, collect information on existing in...
A 68-year-old man, following mitral valve replacement, presented with a low-grade chronic consump... more A 68-year-old man, following mitral valve replacement, presented with a low-grade chronic consumptive coagulopathy. Laboratory analysis showed mild fibrinolysis, minimal effect of coumadin therapy, and a prolonged thrombin time (greater than 150 seconds using bovine IIa). When purified human IIa was used the thrombin time normalized to within 17 seconds of controls, suggesting a possible inhibitor of bovine IIa. An anti-IIa antibody was isolated by protein A-Sepharose (Sigma, St Louis, MO) chromatography followed by affinity chromatography using a bovine IIa-Sepharose column. The effects of this purified anti-IIa antibody on both bovine and human IIa procoagulant and anticoagulant functions were studied. The isolated immunoglobulin G (IgG) was observed to inhibit bovine IIa in all assays tested. This IgG was also able to slightly prolong fibrinogen clotting by human IIa. Using an enzyme-linked immunosorbent assay it was observed that the IgG bound to bovine IIa, bovine II, human IIa...
The incidence of wartime vascular injury has increased and is a leading cause of mortality and mo... more The incidence of wartime vascular injury has increased and is a leading cause of mortality and morbidity. While ligation remains an option, current resuscitation and damage control techniques have resulted in vascular repair being pursued in more than half of wartime injuries. Options for vascular reconstruction are currently limited to autologous vein or synthetic conduits, choices which have not changed in decades, both of which have problems. Autologous vein is preferable but requires time to harvest and may not be available. Synthetic grafts are poorly resistant to infection and associated with thrombotic complications. Recognizing this capability gap, the US Combat Casualty Care Research Program has partnered with academia and industry to support the development and clinical introduction of a bioengineered human acellular vessel. This human acellular vessel has the potential to be an off-the-shelf conduit that is resistant to infection and incorporates well into native tissues. This report reviews the rationale of this military-civilian partnership in medical innovation and provides an update on the clinical use and ongoing study of this new vascular technology. LEVEL OF EVIDENCE: Therapeutic, level III.
Vascular graft infections are a particularly troublesome complication for dialysis patients, many... more Vascular graft infections are a particularly troublesome complication for dialysis patients, many of whom are in an already immunocompromised state. The objective of this review is to detail the risk factors, etiology, diagnosis, perioperative and operative management of vascular graft infections.
In this chapter, the patient population, selection, and strategic planning around the use of the ... more In this chapter, the patient population, selection, and strategic planning around the use of the HeRO graft, as well as the technical considerations, potential pitfalls, complications, and outcomes associated with the device, are discussed.
Background Previous studies have identified risk factors for femoral arterial thrombosis after pa... more Background Previous studies have identified risk factors for femoral arterial thrombosis after paediatric cardiac catheterisation, but none of them have evaluated the clinical and economic significance of this complication at the population level. Therefore, we examined the national prevalence and economic impact of femoral arterial thrombosis after cardiac catheterisation in children. Methods Patients⩽18 years of age who underwent cardiac catheterisation were identified in the 2003–2009 Kids’ Inpatient Database. Patients were stratified by age as follows: <1 year of age or 1–18 years of age. The primary outcome was arterial thrombosis of the lower extremity during the same hospitalisation as cardiac catheterisation. Propensity score matching was used to determine the impact of femoral arterial thrombosis on hospital length of stay, cost, and mortality. Results Among the 11,497 paediatric cardiac catheterisations identified, 4558 catheterisations (39.6%) were performed in children…
The mammalian hemostatic system has evolved to accomplish the task of sealing defects in the card... more The mammalian hemostatic system has evolved to accomplish the task of sealing defects in the cardiovascular system. Hemostasis occurs in and around a disruption in a vascular conduit through which blood normally flows, and is characterized by the localized formation of thrombus. Consequently, the process of hemostasis is influenced by: (1) the biochemical properties of the cellular and soluble components of the hemostatic system, counterregulatory networks, and the vascular conduit; (2) the local hemodynamic conditions, which regulate the influx and efflux of substrates, cofactors, and catalysts, and which also impose loads on the forming clot; and (3) the local mechanical properties of the vasculature. We review the components of the hemostatic and negative regulatory systems and their biochemical functions, and the roles that local hemodynamics play in the regulation of hemostasis
Clinical Journal of the American Society of Nephrology, 2018
BackgroundRestenosis remains a problem in hemodialysis access interventions. Paclitaxel-coated ba... more BackgroundRestenosis remains a problem in hemodialysis access interventions. Paclitaxel-coated balloons have shown promise in reducing access-related restenosis in small trials. The primary hypotheses for our multicenter trial were superior effectiveness at 180 days and noninferior safety at 30 days of a drug-coated balloon compared with conventional angioplasty for treatment of dysfunctional arteriovenous fistulas.Design, setting, participants, & measurementsThis randomized trial enrolled 285 patients with dysfunctional arteriovenous fistulas at 23 centers. Grafts, central venous stenoses, thrombosed fistulas, and immature fistulas were excluded. All patients received angioplasty of the lesion responsible for access dysfunction. After successful angioplasty (≤30% residual stenosis), lesions were treated with either a paclitaxel-coated balloon or an uncoated control balloon of similar design to the drug-coated balloon. Access function during follow-up was determined per centers’ usu...
Journal of vascular and interventional radiology : JVIR, Apr 1, 2018
for the Central Vein Work Group and the Technology Assessment Committee ABBREVIATIONS AV ¼ arteri... more for the Central Vein Work Group and the Technology Assessment Committee ABBREVIATIONS AV ¼ arteriovenous, BCV ¼ brachiocephalic vein, CDE ¼ common data element, CVWG ¼ Central Vein Work Group, IJV ¼ internal jugular vein, IVC ¼ inferior vena cava, SCV ¼ subclavian vein, SVC ¼ superior vena cava, TCVO ¼ thoracic central vein obstruction PREAMBLE This effort to produce a thoracic central vein obstruction (TCVO) reporting document arose from informal discussions at meetings of several professional societies. These societies share a common interest in promoting responsible and sustainable vascular access through education, research, and clinical practice initiatives. TCVO is not only a major clinical problem that impacts vascular access but is also encountered in patients with end-stage renal disease, cancer, infection, parenteral nutrition requirements, cardiac dysrhythmias, and many other conditions. It was recognized that a multidisciplinary coalition would be required to develop a useful comprehensive reporting system acceptable to all major stakeholders in this domain. Participants and Methods This multidisciplinary coalition, called the Central Vein Work Group (CVWG), consists of clinicians and basic scientists from academic and private practices. The clinical specialties of interventional radiology, nephrology, vascular surgery, transplant surgery, pediatrics, hematology/ oncology, cardiology, and clinical anatomy were represented. This document was drafted during a series of Web-based meetings and conference calls. After an organizational outline was established, individual topics were discussed until resolved. Whenever possible, statements contained in this document are based on peer-reviewed literature. All included references are relevant to current practice and free from relationships with industry or other sources of bias.
Time for primary review: 46 days Aims Chronic kidney disease (CKD) is a powerful independent risk... more Time for primary review: 46 days Aims Chronic kidney disease (CKD) is a powerful independent risk factor for cardiovascular events, including vein graft failure. Because CKD impairs the clearance of small proteins, we tested the hypothesis that CKD exacerbates vein graft disease by elevating serum levels of critical cytokines that promote vein graft neointimal hyperplasia.
Supplemental material, sj-pdf-1-jva-10.1177_11297298211018295 for Patient-reported outcomes in he... more Supplemental material, sj-pdf-1-jva-10.1177_11297298211018295 for Patient-reported outcomes in hemodialysis vascular access: A call to action by Karen Woo, Robert Fuld, Amanda Grandinetti, Jeffrey Lawson, Terry Litchfield, Mark Ohan, John Devin Peipert, Matthew B Rivara, Glenda Roberts, Prabir Roy-Chaudhury, Margo Underwood and Robert J Nordyke in The Journal of Vascular Access
Thrombin is a common hemostatic drug used in surgical practice for over 100 years because of its ... more Thrombin is a common hemostatic drug used in surgical practice for over 100 years because of its simplicity and efficacy. Thrombin converts fibrinogen to fibrin, activates platelets, and induces vascular contraction. It is available in multiple forms, including human thrombin, bovine thrombin, and, most recently, human recombinant thrombin. Over 100 case reports of adverse reactions to bovine thrombin include hemorrhage, thrombosis, and substantial immune reaction when used on cardiovascular surgery patients. Approximately 30% of patients exposed to bovine thrombin develop cross-reacting antibodies. Thirty percent of patients with anticlotting factor antibodies develop abnormal coagulation that can be detected by prothrombin time, partial thromboplastin time, or thrombin time, which makes anticoagulation monitoring difficult. Patients with multiple elevated antibodies prior to surgery are also more likely to sustain adverse events. Animal studies confirm these immunological response...
While access-related dysfunction is a clear driver of clinical outcomes and costs, the full impac... more While access-related dysfunction is a clear driver of clinical outcomes and costs, the full impact of vascular access dysfunction on patient experience and quality of life is not fully characterized in the literature. One way to more comprehensively characterize the patient experience from the patient perspective is through patient reported outcomes (PROs). However, the limited implementation of PROs in clinical trials, patient registries, quality measurement, and other research settings has significantly constrained the patient voice in evaluation of vascular access outcomes and vascular access decision-making. To address these issues, the Kidney Health Initiative, a public-private partnership between the American Society of Nephrology and the U.S. Food and Drug Administration, assembled an interdisciplinary workgroup to enhance uptake of access-related PROs with the aims of: (1) reviewing the domains of HRQOL that are affected by vascular access, collect information on existing in...
A 68-year-old man, following mitral valve replacement, presented with a low-grade chronic consump... more A 68-year-old man, following mitral valve replacement, presented with a low-grade chronic consumptive coagulopathy. Laboratory analysis showed mild fibrinolysis, minimal effect of coumadin therapy, and a prolonged thrombin time (greater than 150 seconds using bovine IIa). When purified human IIa was used the thrombin time normalized to within 17 seconds of controls, suggesting a possible inhibitor of bovine IIa. An anti-IIa antibody was isolated by protein A-Sepharose (Sigma, St Louis, MO) chromatography followed by affinity chromatography using a bovine IIa-Sepharose column. The effects of this purified anti-IIa antibody on both bovine and human IIa procoagulant and anticoagulant functions were studied. The isolated immunoglobulin G (IgG) was observed to inhibit bovine IIa in all assays tested. This IgG was also able to slightly prolong fibrinogen clotting by human IIa. Using an enzyme-linked immunosorbent assay it was observed that the IgG bound to bovine IIa, bovine II, human IIa...
The incidence of wartime vascular injury has increased and is a leading cause of mortality and mo... more The incidence of wartime vascular injury has increased and is a leading cause of mortality and morbidity. While ligation remains an option, current resuscitation and damage control techniques have resulted in vascular repair being pursued in more than half of wartime injuries. Options for vascular reconstruction are currently limited to autologous vein or synthetic conduits, choices which have not changed in decades, both of which have problems. Autologous vein is preferable but requires time to harvest and may not be available. Synthetic grafts are poorly resistant to infection and associated with thrombotic complications. Recognizing this capability gap, the US Combat Casualty Care Research Program has partnered with academia and industry to support the development and clinical introduction of a bioengineered human acellular vessel. This human acellular vessel has the potential to be an off-the-shelf conduit that is resistant to infection and incorporates well into native tissues. This report reviews the rationale of this military-civilian partnership in medical innovation and provides an update on the clinical use and ongoing study of this new vascular technology. LEVEL OF EVIDENCE: Therapeutic, level III.
Vascular graft infections are a particularly troublesome complication for dialysis patients, many... more Vascular graft infections are a particularly troublesome complication for dialysis patients, many of whom are in an already immunocompromised state. The objective of this review is to detail the risk factors, etiology, diagnosis, perioperative and operative management of vascular graft infections.
In this chapter, the patient population, selection, and strategic planning around the use of the ... more In this chapter, the patient population, selection, and strategic planning around the use of the HeRO graft, as well as the technical considerations, potential pitfalls, complications, and outcomes associated with the device, are discussed.
Background Previous studies have identified risk factors for femoral arterial thrombosis after pa... more Background Previous studies have identified risk factors for femoral arterial thrombosis after paediatric cardiac catheterisation, but none of them have evaluated the clinical and economic significance of this complication at the population level. Therefore, we examined the national prevalence and economic impact of femoral arterial thrombosis after cardiac catheterisation in children. Methods Patients⩽18 years of age who underwent cardiac catheterisation were identified in the 2003–2009 Kids’ Inpatient Database. Patients were stratified by age as follows: <1 year of age or 1–18 years of age. The primary outcome was arterial thrombosis of the lower extremity during the same hospitalisation as cardiac catheterisation. Propensity score matching was used to determine the impact of femoral arterial thrombosis on hospital length of stay, cost, and mortality. Results Among the 11,497 paediatric cardiac catheterisations identified, 4558 catheterisations (39.6%) were performed in children…
The mammalian hemostatic system has evolved to accomplish the task of sealing defects in the card... more The mammalian hemostatic system has evolved to accomplish the task of sealing defects in the cardiovascular system. Hemostasis occurs in and around a disruption in a vascular conduit through which blood normally flows, and is characterized by the localized formation of thrombus. Consequently, the process of hemostasis is influenced by: (1) the biochemical properties of the cellular and soluble components of the hemostatic system, counterregulatory networks, and the vascular conduit; (2) the local hemodynamic conditions, which regulate the influx and efflux of substrates, cofactors, and catalysts, and which also impose loads on the forming clot; and (3) the local mechanical properties of the vasculature. We review the components of the hemostatic and negative regulatory systems and their biochemical functions, and the roles that local hemodynamics play in the regulation of hemostasis
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Papers by Jeffrey Lawson