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Article ; Online: Digital 3D Topographic Microscopy: Bridging the Gaps Between Macroscopy, Microscopy and Scanning Electron Microscopy.

Rousselle, Serge D

2020 Volume 49, Issue 4, Page(s) 963–970

Abstract: Re-endothelialization of vascular lumen after endovascular procedures is a critical healing milestone and is subjected to routine pathological evaluation during preclinical safety assessment of new cardiovascular devices. Gross evaluation, microscopic ... ...

Abstract	Re-endothelialization of vascular lumen after endovascular procedures is a critical healing milestone and is subjected to routine pathological evaluation during preclinical safety assessment of new cardiovascular devices. Gross evaluation, microscopic evaluation, and scanning electron microscopy (SEM) are the methods of choice for evaluation of vascular surfaces. In this article, we present a new digital imaging approach of surface topography herein referred to as topographical digital microscopy (TDM) that is able to meet the objectives of endovascular healing assessment in a single instrumental platform combined with the same sample preparation techniques as for histology or SEM. This platform is taking advantage of digitally managed illumination, X-Y stitching, and Z-stacking to enable direct optical imaging of tissue surfaces at levels of details ranging from the macroscopic to the cellular level. This technique is enabled by advances in digital optical microscopy and provides images in color and 3 dimensions that can help in the analysis, especially in distinguishing biologically meaningful observations from technical preparation artifacts and in visualizing surface topography.
MeSH term(s)	Histological Techniques ; Microscopy, Electron, Scanning ; Specimen Handling
Language	English
Publishing date	2020-12-29
Publishing country	United States
Document type	Journal Article
ZDB-ID	841009-4
ISSN	1533-1601 ; 0192-6233
ISSN (online)	1533-1601
ISSN	0192-6233
DOI	10.1177/0192623320979908
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Article ; Online: Pathology Approaches to Determine Safety and Efficacy of Cardiac Ablation Catheters.

Stoffregen, William C / Rousselle, Serge D / Rippy, Marian K

Toxicologic pathology

2019 Volume 47, Issue 3, Page(s) 311–328

Abstract: Cardiac electrophysiology utilizes nonimplantable, catheter-based devices for diagnosis and treatment of arrhythmias as well as electroanatomical mapping of cardiac chambers. Gross pathology and histopathological assessments in preclinical studies play ... ...

Abstract	Cardiac electrophysiology utilizes nonimplantable, catheter-based devices for diagnosis and treatment of arrhythmias as well as electroanatomical mapping of cardiac chambers. Gross pathology and histopathological assessments in preclinical studies play critical roles in determining the safety and efficacy of cardiac ablation systems used to treat tachyarrhythmias. The pathologist must assess ablation sites, adjacent structures and organs, and downstream organs to characterize the effects of the ablation treatment and determine whether adverse local reactions, collateral injury, or downstream thromboembolism are present. Histopathological assessment serves as an adjunct to electroanatomical data in determining efficacy in preclinical studies. Histopathology is the standard in definitively demonstrating transmurality of ablation lesions, which is necessary for complete conduction block, as well as showing the linear or circumferential distribution of a contiguous, transmural ablation lesion necessary for electroanatomical isolation of entire target structures such as pulmonary veins and the cavotricuspid isthmus, which are involved in propagating certain arrhythmias. This article will detail gross and histological methods for the pathology assessment of preclinical studies evaluating the safety and/or efficacy of cardiac ablation catheter systems as well as discuss correlation of pathology data with other supporting evidence for safety and efficacy such as acute, electroanatomical data.
MeSH term(s)	Animals ; Cardiac Catheters/adverse effects ; Cardiac Catheters/standards ; Catheter Ablation/instrumentation ; Cryosurgery/instrumentation ; Equipment Safety ; Heart Atria/pathology ; Heart Atria/physiopathology ; Heart Atria/surgery ; Heart Conduction System/physiopathology ; Heart Ventricles/pathology ; Heart Ventricles/physiopathology ; Heart Ventricles/surgery ; Tachycardia/surgery
Language	English
Publishing date	2019-02-06
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	841009-4
ISSN	1533-1601 ; 0192-6233
ISSN (online)	1533-1601
ISSN	0192-6233
DOI	10.1177/0192623319826063
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Article ; Online: Evaluation of a Novel Spun Polytetrafluoroethylene Stent Graft in an Ovine External Iliac Artery Model.

Dolmatch, Bart L / Hall, John W / Mower, Wayne L / Rousselle, Serge D

Journal of vascular and interventional radiology : JVIR

2020 Volume 31, Issue 3, Page(s) 494–502

Abstract: Purpose: To evaluate the patency, cellular response, and thrombogenicity of a novel vascular stent graft.: Materials and methods: Test stent grafts, incorporating luminal spun polytetrafluoroethylene and a nonpermeable fluoropolymer layer, and ... ...

Abstract	Purpose: To evaluate the patency, cellular response, and thrombogenicity of a novel vascular stent graft. Materials and methods: Test stent grafts, incorporating luminal spun polytetrafluoroethylene and a nonpermeable fluoropolymer layer, and control stent grafts, constructed of permeable expanded polytetrafluoroethylene, were implanted in the external iliac arteries of 14 adult sheep with a median weight of 73.4 kg ranging from 60.6-86.8 kg for 30 (n = 4), 90 (n = 4), and 180 (n = 6) days. Angiographic patency and percent diameter stenosis (%DS) were assessed at termination. Excised stent grafts were fixed and stained for histopathologic analysis, including neointimal coverage (NC) assessment. Results: Test and control device migration occurred in 1 animal, resulting in test device thrombosis. Both devices were excluded from analysis. Mean %DS in test and control implants was 4.6% and 8.2% (P = .563), 2.0% and 10.9% (P = .363), and 2.1% and 10.3% (P = .009) at 30, 90, and 180 days, respectively. Median NC scores at 30, 90, and 180 days were significantly lower in middle test device sections (P < .05). Proximal and distal test and control sections exhibited similar median NC scores at all time periods (P > .05). When present, test and control devices exhibited no neointimal detachment from the graft surface. Except for the migrated test device, no thrombus was observed. Transgraft cellular migration was absent in test devices but present in control devices with tissue accumulation around the stent struts. Conclusions: Test and control devices demonstrated excellent patency in an ovine model. Compared to the control, test devices exhibited significantly lower %DS values at 180 days and significantly lower mid-device NC scores at 30, 90, and 180 days.
MeSH term(s)	Animals ; Blood Vessel Prosthesis ; Blood Vessel Prosthesis Implantation/adverse effects ; Blood Vessel Prosthesis Implantation/instrumentation ; Female ; Foreign-Body Migration/etiology ; Graft Occlusion, Vascular/etiology ; Graft Occlusion, Vascular/pathology ; Graft Occlusion, Vascular/physiopathology ; Iliac Artery/diagnostic imaging ; Iliac Artery/pathology ; Iliac Artery/physiopathology ; Iliac Artery/surgery ; Male ; Materials Testing ; Models, Animal ; Neointima ; Polytetrafluoroethylene/chemistry ; Prosthesis Design ; Sheep, Domestic ; Stents ; Thrombosis/etiology ; Thrombosis/pathology ; Thrombosis/physiopathology ; Time Factors ; Vascular Patency
Chemical Substances	Polytetrafluoroethylene (9002-84-0)
Language	English
Publishing date	2020-01-17
Publishing country	United States
Document type	Journal Article
ZDB-ID	1137756-2
ISSN	1535-7732 ; 1051-0443
ISSN (online)	1535-7732
ISSN	1051-0443
DOI	10.1016/j.jvir.2019.07.036
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Article ; Online: Medical Device Histology and Pathology: A Horse of a Different Color.

Paulin, Jaime / Rousselle, Serge D / Fossey, Stacey

Toxicologic pathology

2018 Volume 47, Issue 3, Page(s) 201–202

Abstract: Medical devices comprise a wide variety of therapeutic tools aimed at modulating or restoring organ function. Devices may be implanted or activated temporally or permanently, and are used to deliver a wide range of therapies such as drugs, electrical ... ...

Abstract	Medical devices comprise a wide variety of therapeutic tools aimed at modulating or restoring organ function. Devices may be implanted or activated temporally or permanently, and are used to deliver a wide range of therapies such as drugs, electrical stimulation, laser, thermal energy, offer mechanical support, and restore sensory functions. Technological advancements allow improvement and development of devices at a rapid pace. This special issue of Toxicologic Pathology addresses a need for more publications focused on pathology evaluation of medical devices in preclinical studies and highlights fundamental approaches through practical examples bringing into perspective the essential role of pathologists in this field.
MeSH term(s)	Animals ; Biocompatible Materials/adverse effects ; Biocompatible Materials/standards ; Equipment Safety ; Equipment and Supplies/adverse effects ; Equipment and Supplies/standards ; Humans ; Materials Testing/methods ; Materials Testing/standards ; Pathology/methods ; Pathology/standards
Chemical Substances	Biocompatible Materials
Language	English
Publishing date	2018-12-25
Publishing country	United States
Document type	Introductory Journal Article
ZDB-ID	841009-4
ISSN	1533-1601 ; 0192-6233
ISSN (online)	1533-1601
ISSN	0192-6233
DOI	10.1177/0192623318815607
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Article ; Online: Pathology of Bioabsorbable Implants in Preclinical Studies.

Rousselle, Serge D / Ramot, Yuval / Nyska, Abraham / Jackson, Nicolette D

Toxicologic pathology

2019 Volume 47, Issue 3, Page(s) 358–378

Abstract: Bioabsorbable implants can be advantageous for certain surgical tissue bioengineering applications and implant-assisted tissue repair. They offer the obvious benefits of nonpermanence and eventual restoration of the native tissue's biomechanical and ... ...

Abstract	Bioabsorbable implants can be advantageous for certain surgical tissue bioengineering applications and implant-assisted tissue repair. They offer the obvious benefits of nonpermanence and eventual restoration of the native tissue's biomechanical and immunological properties, while providing a structural scaffold for healing and a route for additional therapies (i.e., drug elution). They present unique developmental, imaging, and histopathological challenges in the conduct of preclinical animal studies and in interpretation of pathology data. The bioabsorption process is typically associated with a gradual decline (over months to years) in structural strength and integrity and may also be associated with cellular responses such as phagocytosis that may confound interpretation of efficacy and safety end points. Additionally, as these implants bioabsorb, they become increasingly difficult to isolate histologically and thus imaging modalities such as microCT become very valuable to determine the original location of the implants and to assess the remodeling response in tandem with histopathology. In this article, we will review different types of bioabsorbable implants and commonly used bioabsorbable materials; additionally, we will address some of the most common challenges and pitfalls confronting histologists and pathologists in collecting, handling, imaging, preparing tissues through histology, evaluating, and interpreting study data associated with bioabsorbable implants.
MeSH term(s)	Absorbable Implants/adverse effects ; Absorbable Implants/standards ; Animals ; Biocompatible Materials/adverse effects ; Biocompatible Materials/standards ; Equipment Safety/instrumentation ; Equipment Safety/methods ; Histological Techniques/methods ; Humans ; Image Processing, Computer-Assisted ; Materials Testing/instrumentation ; Materials Testing/methods ; Pathology/methods ; Species Specificity ; Tissue Engineering ; Tissue Scaffolds/adverse effects ; Tissue Scaffolds/standards
Chemical Substances	Biocompatible Materials
Language	English
Publishing date	2019-01-30
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	841009-4
ISSN	1533-1601 ; 0192-6233
ISSN (online)	1533-1601
ISSN	0192-6233
DOI	10.1177/0192623318816681
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Article ; Online: D-PLEX

Ramot, Yuval / Nedvetzki, Shlomo / Rosenfeld, Sefi / Rousselle, Serge D / Nyska, Abraham / Emanuel, Noam

Toxicologic pathology

2020 Volume 48, Issue 5, Page(s) 677–685

Abstract: Surgical site infections (SSIs) are a common surgical-related complication. To avoid these complications, a new biodegradable polymer-lipid encapsulation matrix that provides controlled release of doxycycline (doxycycline/polymer-lipid encapsulation ... ...

Abstract	Surgical site infections (SSIs) are a common surgical-related complication. To avoid these complications, a new biodegradable polymer-lipid encapsulation matrix that provides controlled release of doxycycline (doxycycline/polymer-lipid encapsulation matrix [D-PLEX]) has been developed. The aim of this comprehensive study was to evaluate the potential safety of D-PLEX
MeSH term(s)	Animals ; Doxycycline/administration & dosage ; Drug Delivery Systems ; Humans ; Models, Animal ; Surgical Wound Infection ; Swine ; Swine, Miniature
Chemical Substances	Doxycycline (N12000U13O)
Language	English
Publishing date	2020-06-11
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	841009-4
ISSN	1533-1601 ; 0192-6233
ISSN (online)	1533-1601
ISSN	0192-6233
DOI	10.1177/0192623320928902
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Article ; Online: Comprehensive Preclinical Postmortem Evaluation of Valvular Prosthesis.

Tellez, Armando / Dillon, Krista N / Rousselle, Serge D

Toxicologic pathology

2017 Volume 45, Issue 8, Page(s) 1077–1090

Abstract: Transcatheter prosthetic valves are heralding a new era in interventional cardiology and affording real therapeutic options to categories of patients currently medically disqualified, namely the elderly and higher risk individuals. An increasing variety ... ...

Abstract	Transcatheter prosthetic valves are heralding a new era in interventional cardiology and affording real therapeutic options to categories of patients currently medically disqualified, namely the elderly and higher risk individuals. An increasing variety of novel artificial valve designs and delivery systems are being tested preclinically. Cardiologists and surgeons are generally well-equipped to assess deliverability and function; however, methods for pathological evaluation of animals enrolled in transcatheter valve implant testing are scant, often vague, and far from consensual. Through this manuscript, we present and discuss a comprehensive evaluation platform that is proving reliable, reproducible, effective, and applicable to most, if not all, types and locations of valvular prostheses.
MeSH term(s)	Animals ; Equipment Safety/standards ; Heart Atria/diagnostic imaging ; Heart Atria/pathology ; Heart Valve Prosthesis/adverse effects ; Heart Valve Prosthesis/standards ; Heart Ventricles/diagnostic imaging ; Heart Ventricles/pathology ; Image Processing, Computer-Assisted ; Microscopy, Electron, Scanning ; Models, Animal ; Risk Assessment ; Sheep ; Surface Properties ; Swine ; Transcatheter Aortic Valve Replacement ; X-Ray Microtomography
Language	English
Publishing date	2017
Publishing country	United States
Document type	Journal Article
ZDB-ID	841009-4
ISSN	1533-1601 ; 0192-6233
ISSN (online)	1533-1601
ISSN	0192-6233
DOI	10.1177/0192623317740325
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Article ; Online: Histology Strategies for Medical Implants and Interventional Device Studies.

Rousselle, Serge D / Wicks, Joan R / Tabb, Brian C / Tellez, Armando / O'Brien, Maureen

Toxicologic pathology

2019 Volume 47, Issue 3, Page(s) 235–249

Abstract: Histology of medical devices poses a variety of unique challenges. Comprehensive histologic assessment of medical devices often requires spatial context and high-quality retention of the device-tissue interface. However, the composition of many medical ... ...

Abstract	Histology of medical devices poses a variety of unique challenges. Comprehensive histologic assessment of medical devices often requires spatial context and high-quality retention of the device-tissue interface. However, the composition of many medical devices is often not amenable to traditional paraffin embedding and thus alternative specialized methodologies such as hard resin embedding must be used. Hard resin embedding requires specialized laboratory technical expertise and equipment, and the fixation techniques and resin composition used markedly impact the feasibility of immunohistochemistry. For the continuity of spatial context during histologic evaluation, additional imaging methods such as macrophotography, radiography, micro-Computerized Tomography (microCT), or magnetic resonance imaging (MRI) can be used to guide sectioning and to complement histologic findings. Although standardized approaches are scarce for medical devices, important considerations specific to medical device histology are discussed, including general specimen preparation, special considerations for devices by organ system, and the challenges of immunohistochemistry. Histologic preparation of medical devices must be thoughtful, thorough, and tailored to achieve optimal histologic outcomes for complex, valuable, and often limited implant specimens.
MeSH term(s)	Algorithms ; Animals ; Biocompatible Materials/standards ; Equipment Safety/standards ; Histological Techniques/methods ; Humans ; Immunohistochemistry ; Materials Testing/methods ; Materials Testing/standards ; Prostheses and Implants/adverse effects ; Prostheses and Implants/standards ; Specimen Handling
Chemical Substances	Biocompatible Materials
Language	English
Publishing date	2019-02-14
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	841009-4
ISSN	1533-1601 ; 0192-6233
ISSN (online)	1533-1601
ISSN	0192-6233
DOI	10.1177/0192623319827288
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Article ; Online: Chronic myocardial and coronary arterial effects of intracoronary supersaturated oxygen therapy in swine with normal and ischemic-reperfused myocardium.

Kaluza, Grzegorz L / Creech, Jeffrey L / Furer, Ariel / Afari, Maxwell E / Milewski, Krzysztof / Yi, Geng-Hua / Cheng, Yanping / Conditt, Gerard B / McGregor, Jenn C / Blum, Donald / Rousselle, Serge D / Granada, Juan F / Burkhoff, Daniel

Scientific reports

2022 Volume 12, Issue 1, Page(s) 5785

Abstract: The study assessed chronic myocardial, coronary and systemic effects of intracoronary supersaturated oxygen ( ... ...

Abstract	The study assessed chronic myocardial, coronary and systemic effects of intracoronary supersaturated oxygen (SSO
MeSH term(s)	Animals ; Coronary Thrombosis ; Coronary Vessels/pathology ; Myocardial Infarction/pathology ; Myocardium/pathology ; Oxygen ; Swine
Chemical Substances	Oxygen (S88TT14065)
Language	English
Publishing date	2022-04-06
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2615211-3
ISSN	2045-2322 ; 2045-2322
ISSN (online)	2045-2322
ISSN	2045-2322
DOI	10.1038/s41598-022-09776-8
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Article ; Online: Scientific and Regulatory Policy Committee Points to Consider for Medical Device Implant Site Evaluation in Nonclinical Studies.

O'Brien, Maureen T / Schuh, JoAnn C L / Wancket, Lyn M / Cramer, Sarah D / Funk, Kathleen A / Jackson, Nicolette D / Kannan, Kamala / Keane, Kevin / Nyska, Abraham / Rousselle, Serge D / Schucker, Adrienne / Thomas, Valerie S / Tunev, Stefan

Toxicologic pathology

2022 Volume 50, Issue 4, Page(s) 512–530

Abstract: Nonclinical implantation studies are a common and often critical step for medical device safety assessment in the bench-to-market pathway. Nonclinical implanted medical devices or drug-device combination products require complex macroscopic and ... ...

Abstract	Nonclinical implantation studies are a common and often critical step for medical device safety assessment in the bench-to-market pathway. Nonclinical implanted medical devices or drug-device combination products require complex macroscopic and microscopic pathology evaluations due to the physical presence of the device itself and unique tissue responses to device materials. The Medical Device Implant Site Evaluation working group of the Society of Toxicologic Pathology's (STP) Scientific and Regulatory Policy Committee (SRPC) was tasked with reviewing scientific, technical, and regulatory considerations for these studies. Implant site evaluations require highly specialized methods and analytical schemes that should be designed on a case-by-case basis to address specific study objectives. Existing STP best practice recommendations can serve as a framework when performing nonclinical studies under Good Laboratory Practices and help mitigate limitations in standards and guidances for implant evaluations (e.g., those from the International Organization for Standardization [ISO], ASTM International). This article integrates standards referenced by sponsors and regulatory bodies with practical pathology evaluation methods for implantable medical devices and combination products. The goal is to ensure the maximum accuracy and scientific relevance of pathology data acquired during a medical device or combination drug-device implantation study.
MeSH term(s)	Policy
Language	English
Publishing date	2022-06-28
Publishing country	United States
Document type	Journal Article
ZDB-ID	841009-4
ISSN	1533-1601 ; 0192-6233
ISSN (online)	1533-1601
ISSN	0192-6233
DOI	10.1177/01926233221103202
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