Audible Bleeding

We are excited to share our discussion with Dr. Carmen Johnson and Dr. Ronald Fairman from the Food and Drug Administration on the approval processes and the post-market surveillance of medical devices. 

Dr. Carmen Gacchina Johnson is the Assistant Director, Vascular & Endovascular Devices at the Food and Drug Administration. She has a Ph.D. in Bioengineering and has been with the FDA since 2012. Her area of expertise is in cardiovascular devices. 

Dr. Ronald Fairman is an Emeritus Professor of Surgery and former Chief of the Division of Vascular Surgery at the University of Pennsylvania, as well as a former President of the Society for Vascular Surgery. He is speaking to us today in his role as Medical Officer on the Vascular and Endovascular Devices Team (VEDT)

A History of Medical Device Regulation & Oversight in the United States

MedWatch Forms for FDA Safety Reporting

Virtual two-day meeting of the CDRH Circulatory System Devices Panel of the Medical Devices Advisory Committee in Quarter4 of 2021

To sign up for news about device approvals, recalls, and other FDA actions and announcements, we recommend subscribing to CDRH News.

** Leadership Development Program Applications are open and due by July 16, 2021 **

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Matt Chia and Ali Irshad sit down with Drs. Meryl Simon Logan and Sree Kanna in part 2 of our series for newly-matched vascular residents embarking on their next stage of training.

Show Guests:

• Dr. Meryl Simon Logan (@ProleneQueen) is a staff vascular surgeon at the Olin E. Teague Central Texas Veteran’s Health Care System in Temple, Texas, as well as holding an adjunct assistant professorship at Texas A&M.  She currently holds the rank of Major in the U.S. Air Force, as well as chairs the SVS Social Media Committee.  She completed an integrated residency in vascular surgery at the University of California in Davis and received her medical degree from the Drexel University College of Medicine in Philadelphia.  
• Dr. Sree Kanna (@VulnerableAorta) is finishing his intern year in vascular surgery at McGill University in Montreal, Quebec. Originally from Kuala Lumpur in Malaysia, he completed his medical training at the Dalhousie Medical School in Halifax, Nova Scotia.  He has an interest in aortic surgery and surgical outcomes in indigenous populations, and on his days off describes himself as an experimental cook and a horror movie addict.

Relevant Links:

• VSITE Information: https://www.absurgery.org/default.jsp?certvsite
• SVS VESAP 5: https://vascular.org/career-tools-training/vesap5
• Vascular SCORE Curriculum: https://www.surgicalcore.org/public/curriculum#vascsurg
• SVS Research Opportunities in Vascular Surgery: https://vascular.org/research-quality/research-opportunities

If you missed it, check out "So You've Matched into Vascular...Now What? (Part 1).

Host Introductions:

• Dr. Irshad (@AIrshad_MD) is an assistant professor at the University of Connecticut in Hartford. He completed his integrated vascular surgery residency at the Houston Methodist Hospital, earned his medical degree from the University of Massachusetts in Worcester.  He has special interests in medical innovation, novel devices, complex aortic disease, and diagnostic imaging.
• Dr. Chia (@chia_md) is in his 5th of 7 years in the integrated vascular surgery program at Northwestern University.  He obtained his medical degree from the University of Illinois College of Medicine and is obtaining a Master’s in Health Services and Outcomes Research at Northwestern.  He is part of the Vascular SECOND trial team at the Surgical Outcomes and Quality Improvement Center and is an avid podcast fan.

Follow us @audiblebleeding

Learn more about us at https://www.audiblebleeding.com/about-1/ and #jointheconversation.

Adam and Dr. Sheahan join Miss Eilidh Gunn and Dr. Steven Yule to discuss human factors engineering, coaching, and the Non-technical Skills for Surgeons (NOTSS) taxonomy and how they can be applied to improving vascular surgery. 

Professor Steven Yule (@NOTSS_lab) is the Chair of Behavioural Sciences at the University of Edinburgh, Associate Professor at Harvard, and Director of Non-Technical Skills at the Royal College of Surgeons of Edinburgh. He is a Human Factors scientist and organizational psychologist. He is internationally recognized for his research on non-technical skills, patient safety, and simulation in surgery. His interests are in peer and computer assessments of surgical performance from video, safety in low and middle-income contexts, surgical coaching, sabermetrics, and astronaut training for long-duration spaceflight. He is also currently the program Director for MSc Patient Safety and Clinical Human Factors at Edinburgh University.

To Learn More about NOTSS:

• RCSEd Let’s Talk Surgery Podcast: Performance Project
• Enhancing Surgical Performance: A Primer on Non-technical Skills
• NOTSS Handbook
• Non-technical Skills for Surgeons RCSEd Website
• Non-Technical Skills for Surgeons Website (notss.org)
• The future training of non-technical skills for surgeons (NOTSS) - YouTube

Relevant links

• Moulton CA, Regehr G, Mylopoulos M, MacRae HM. Slowing down when you should: a new model of expert judgment. Acad Med. 2007 Oct;82(10 Suppl):S109-16.
• Hu YY, Peyre SE, Arriaga AF, et al. Postgame analysis: using video-based coaching for continuous professional development. J Am Coll Surg. 2012;214(1):115-124.
• Sudol NT, Guaderrama NM, Honsberger P, et al. Prevalence and Nature of Sexist and Racial/Ethnic Microaggressions Against Surgeons and Anesthesiologists. JAMA Surg. 2021 May 1;156(5):e210265.
• CIEHF White Paper: Human Factors for Health Care and Social Care
• Ariadne Labs

Co-hosts

• Miss Eilidh Gunn (@eil1_g) is currently a PhD candidate in Clinical Surgery at the University of Edinburgh. Her research interests are human factors, non-technical skills and surgical coaching.
• Dr. Mal Sheahan is a regular contributor to the podcast, editor for Vascular Specialist and co-chair of the SVS wellness taskforce overseeing their new initiative in peer coaching.

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In this episode of our monthly JVS series, Jacob, Matt, and Yasong discuss the latest Editor’s Choice articles with Editor-in-Chief, Dr. Peter Gloviczki.

Dr. Gloviczki YouTube Video

• Validation of the Global Limb Anatomic Staging System in first-time lower extremity revascularization (Editor’s Choice)
• Comparison of open- and closed-cell stent design outcomes after carotid artery stenting in the Vascular Quality Initiative (CME)
• Endovascular interventions for claudication do not meet minimum standards for the Society for Vascular Surgery efficacy guidelines  
• Comparison of transfemoral versus upper extremity access to antegrade branches in branched endovascular aortic repair 

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In this “Meet the Authors” Episode, Jacob and Matt Chia sit down with Dr. Katharine McGinigle to discuss her upcoming article in the June issue of the JVS titled, “Sex-related disparities in intervention rates and type of intervention in patients with aortic and peripheral arterial diseases in the National Inpatient Sample Database.”

Dr. McGinigle is an assistant professor of surgery at the University of North Carolina School of Medicine, where she also is the surgical director of the enhanced recovery after surgery program.  She completed her medical degree, master’s of public health, and general surgery residency all at UNC, along with a fellowship in vascular surgery at Duke University.

Sign up for the SVS Journal Club on June 9, 2021 to discuss this paper further!

Relevant Links:

Article: Sex-related disparities in intervention rates and type of intervention in patients with aortic and peripheral arterial diseases in the National Inpatient Sample Database

Previous Audible Bleeding episode with Melina Kibbe

Frank J. Veith International Society: How to Promote Women in Vascular Surgery Webinar

In this month’s episode of our JVS - VL Editor’s Choice series, Jacob, Farooq, and Robin discuss May’s selected articles with Senior Editor of the JVS, Dr. Peter Lawrence.

Dr. Lawrence YouTube Video

Articles Discussed:

• Predictors of intracranial hemorrhage in patients treated with catheter-directed thrombolysis for deep vein thrombosis 
• A retrospective comparison of thrombectomy followed by stenting and thrombectomy alone for the management of deep vein thrombosis with May-Thurner syndrome 
• Three-year results of a randomized controlled trial comparing mechanochemical and thermal ablation in the treatment of insufficient great saphenous veins 
• Propofol administration during catheter-directed interventions for intermediate-risk pulmonary embolism is associated with major adverse events 

If you enjoy our content, please contribute to Support Audible Bleeding!

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Matt Chia and Ali Irshad sit down with Drs. Regina Husman and Kirthi Bellamkonda to answer your questions from Twitter about how newly-matched vascular residents can set themselves up for success in their residency.

Show Guests:

• Dr. Regina Husman (@reginahusman) is a first-year integrated vascular surgery resident at the University of Texas Health Science Center at Houston. She is originally from Jakarta, Indonesia, and earned her medical degree at UCLA. She is interested in pursuing research in hemodialysis access complications and innovative endovascular techniques in treating peripheral arterial disease.
• Dr. Kirthi Bellamkonda (@kirthisb) is finishing her 4th year of medical school at Yale and is the incoming integrated vascular intern at Dartmouth. She is passionate about using medical innovation to increase access to vascular care and spent her research time in medical school developing low-cost vascular tools with Butterfly Network. 

Relevant Links:

• APDVS Course List
• Audible Bleeding Episode on Vascular Decision Making Book
• Methodist Intern Bootcamp

Host Introductions:

• Dr. Ali Irshad (@AIrshad_MD) is an assistant professor at the University of Connecticut in Hartford. He completed his integrated vascular surgery residency at the Houston Methodist Hospital, earned his medical degree from the University of Massachusetts in Worcester.  He has special interests in medical innovation, novel devices, complex aortic disease, and diagnostic imaging.
• Dr. Matt Chia (@chia_md) is in his 5th of 7 years in the integrated vascular surgery program at Northwestern University.  He obtained his medical degree from the University of Illinois College of Medicine and is obtaining a Master’s in Health Services and Outcomes Research at Northwestern.  He is part of the Vascular SECOND trial team at the Surgical Outcomes and Quality Improvement Center and is an avid podcast fan.

Follow us @audiblebleeding

Learn more about us at https://www.audiblebleeding.com/about-1/ and #jointheconversation.

Adam, Robin, and Dr. Forbes sit down with Drs Eldrup-Jorgensen and Nelson to discuss in detail the SVS Foundation’s newest initiative, the VISTA program, and one of the first funded pilot projects.

• Jens Eldrup-Jorgensen, MD is a professor of surgery at Tufts University and Maine Medical Center and medical director for the Society of Vascular Surgery for the Vascular Quality Initiative. He is the innovative force behind the development of the Vascular Volunteers Improve Service to All Program, also known as VISTA.
• Peter Nelson, MD (@prn19) is the Professor and Chief of Vascular Surgery, Mary Louise Todd Chair in Cardiovascular Research, OU College of Medicine and leads one of the first funded pilot projects working with indigenous communities in Oklahoma.

Relevant Links:

• Vascular Volunteers Improve Service to All (VISTA) Program

Co-host introductions

• Thomas Forbes, MD (@TL_forbes) is a professor of surgery and RJ Elliot Chair and Division Head of Vascular Surgery at the University of Toronto and was our 4th guest on the podcast and has been a major supporter of our work and will be joining our team more regularly.
• Robin Osofsky, MD (@OsofskyRobin) is a general surgery resident at the University of New Mexico who is interested in applying for vascular surgery.

Follow us @audiblebleeding

Learn more about us at https://www.audiblebleeding.com/about-1/ and #jointheconversation.

In this episode of our monthly JVS series, Jacob, Kate, and Philip discuss the latest Editor’s Choice articles with Senior Editor, Dr. Peter Lawrence.

Dr. Lawrence YouTube Video

• Association between surgeon case volume and years of practice experience with open abdominal aortic aneurysm repair outcomes (Editor’s Choice)
• Lipoprotein(a) levels and risk of abdominal aortic aneurysm in the Women's Health Initiative
• Safety of vascular interventions performed in an office-based laboratory in patients with low/moderate procedural risk
• Temporary intravascular shunt use improves early limb salvage after extremity vascular injury (CME)  

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Rachael and Francesca discuss with Mr. Jonathan Boyle and Aminder vascular surgery registries in the UK, how they contribute to device safety and lessons learned from the Nellix experience.

Mr. Jonathan Boyle MD FRCS graduated from the University of Leicester in 1991, completed a Doctor of Medicine postgraduate research degree in 2000, and was appointed as a consultant vascular surgeon in Cambridge University Hospitals NHS Trust in 2002, where he was Clinical Lead for Vascular Surgery from 2014-17.

He has held numerous national and international leadership roles.  Amongst others, he is Vice President of the Vascular Society of Great Britain and Ireland (VSGBI), Past President of the British Society for Endovascular Therapy, and Section Editor of the European Journal of Vascular and Endovascular Surgery.

During his roles as Clinical Lead for the UK’s National Vascular Registry (NVR) and Chair of the VSGBI Audit and Quality Improvement Committee, he led the development of the Peripheral Artery Disease Quality Improvement Framework and, more recently, has introduced the incorporation of device-specific information into the NVR.  Under his leadership, the NVR team won the HQIP Team of the Year 2020 award in recognition of their “outstanding work on registry device capture, quality improvement and a rapid response to COVID-19”.  He has also worked closely with Medicines and Healthcare products Regulatory Agency on failing vascular devices.

Aminder Singh MBBS is an Academic Clinical Fellow at the University of Cambridge and vascular surgery specialty trainee in the East of England, currently undertaking research investigating the development of stem cell models to characterize aortopathy variants.  He is the venous and European rep on the Rouleaux Club Executive Committee.

Co-host: Francesca Guest MBChB is a vascular surgery specialty trainee on the South West England training program, currently working in Exeter.  She is the Association for Surgeons in Training (ASiT) rep on the Rouleaux Club Executive Committee.

Resources:

• UK Vascular Services Quality Improvement Programme (including the National Vascular Registry): https://www.vsqip.org.uk
• Vascular Society of Great Britain and Ireland: https://www.vascularsociety.org.uk
• UK National Joint Registry: https://www.njrcentre.org.uk/njrcentre/
• British Society for Endovascular Therapy: https://www.bset.co.uk

Relevant papers:

• Singh AA, Benaragama KS, Pope T, Coughlin PA, Winterbottom AP, Harrison SC, Boyle JR. Progressive Device Failure at Long Term Follow Up of the Nellix EndoVascular Aneurysm Sealing (EVAS) System. Eur J Vasc Endovasc Surg. 2021 Feb;61(2):211-218. doi: 10.1016/j.ejvs.2020.11.004. Epub 2020 Dec 7
• Singh AA, Boyle JR. Introduction of New Medical Devices: Lessons Learned From Experience With Endovascular Aneurysm Sealing. J Endovasc Ther. 2020 Feb;27(1):160-162.
• Singh AA, Boyle JR. Readmission and Re-intervention are Better Measures of EVAR Quality. Eur J Vasc Endovasc Surg. 2020 Oct;60(4):518. doi: 10.1016/j.ejvs.2020.08.011

Erratum: In the original publication, Mr. Singh stated that the Nellix device had been approved by the FDA.  This is incorrect and this device is still considered investigational in the USA.  The audio has been updated to reflect this correction.