Vein Specialist Newsletter: DVT Treatment Update, Jan 2023

Table of Contents

Message from the Editor
Steve Elias, MD

Message from the Guest Editor
Edgar Guzman, MD, FACS

New Year’s Dissolutions

Lyrics for a New Vascular World
Oscar Moreno, MD

DEI in the New Year
Kathleen Ozsvath, MD and Anil Hingorani, MD

Sexism in Research and Publishing: A trend on its way out
Andrea Obi, MD

2,800-Mile Step
Sebastian Cifuentes, MD

Rethinking thrombolytics and stand-alone anticoagulation in the age of advanced mechanical thrombectomy for the treatment of deep vein thrombosis
Venkat Tummala, MD

Thromboprophylaxis: An often-forgotten part of endovenous intervention
Benedict R.H. Turner, Matthew Machin, and Alun H. Davies

VENOUS2023

VENOUS2023 Full Agenda

Kick Off Your Boots at the VENOUS2023 Gala

Roundtable Discussion with VENOUS2023 Program Chair and Speakers Venous Edge Video

Poster Session at VENOUS2023
Nasim Hedayati, MD, MS, MAS

DEI Session Invitation
Sheila Blumberg, MD, MS, RPVI

A Welcome Reception You Don’t Want to Miss!
Antonio Solano, MD

Medtronic Symposium Invitation
Stephanie Brucato and Daniel J. Denmark, PhD, MS

International

Introduction to the German Society of Phlebology
Erika Mendoza

Membership

Welcome New AVF Members!

AVF Health Policy Committee at Work for You AVF Health Policy Committee

Copyright © 2023 by The American Venous Forum. All rights reserved.

EDITOR-IN-CHIEF Steve Elias, MD 

EXECUTIVE EDITOR John Forbes, MBA 

MANAGING EDITOR Allie Woodward 

PUBLICATION DESIGNER Christine Rataj 

Message from the Editor

Steve Elias, MD Editor-in-Chief, Vein Specialist

 

Dissolutions, Resolutions, Any Solutions?

The new year issue of Vein Specialist has traditionally had a guest editor. Last year and this year it is Edgar Guzman, a member of the newsletter committee. Vein Specialist looks at the new year. Edgar came up with the theme and the title. His letter follows. Before reading his, I leave you with some iconic opening lines of English literature to help you ponder the coming year. Food for thought. They speak for themselves:

1. “In my younger and more vulnerable years my father gave me some advice that I’ve been turning over in my mind ever since.” The Great Gatsby, F. Scott Fitzgerald, 1925.
2. “It is a truth universally acknowledged, that a single man in possession of a good fortune, must be in wont of a wife”. Pride And Prejudice, Jane Austen, 1813.
3. “It was the best of times, it was the worst of times…” A Tale of Two Cities, Charles Dickens, 1859.
4. “He was an old man who fished alone in a skiff in the Gulf Stream and he had gone 84 days without taking a fish.” The Old Man and The Sea,Ernest Hemingway, 1952.

And now read Edgar’s opening lines to this issue.

Message from the Guest Editor

Edgar Guzman, MD, FACS Member, AVF Newsletter Committee

 

I don’t keep a diary, but if I did, I would hope my New Year’s entry would not be a list of (more) things to do and achieve in 2023. Rather, I would prefer to dissect where I am and how I got here and what I have learned in the process. I hope a clear course adjustment would emerge from it. Thinking of dissolution as a resolution.

So… what have I learned this past year? A key lesson was that when you say “yes” to something you are saying “no” to something else, whether you know it or not. That’s nearly self-evident, but nonetheless profound, because it acknowledges our finitude–only so many hours in a day and minutes of attention; only so many repetitions a body can endure. Failure to recognize this is a big part of why New Year’s resolutions fail.

Our culture abhors trade-offs; there is a definite negative connotation to the phrase. But does it follow that we are to endlessly accumulate more objects and undertake more activities?

Beyond being inevitable, these choices can be empowering. We need to start thinking of them as trade-ups. I had a few of those this past year. I got better at trading “me” time for family time; did less news reading and more book reading and spent more time with direct experiences rather than those mediated by a phone screen. I think I am the better for it.

Our authors in this issue share different experiences regarding changes much more significant than those above. You will see the common thread is their decision to say “no” to something that had ceased to be as important or simply recognized as flawed and saying “yes” to a better future.

Like our authors, let us be full of intention and hope when saying “no” and make way for better things to come. Sometimes it is better to dissolve to be able to resolve.

Happy New Year!

Lyrics for a New Vascular World

 

Oscar Y. Moreno Rocha, MD Conrad Jobst Postdoctoral Research Fellow Vascular Surgery, Michigan Medicine

 

 

In 1969, the Rolling Stones released the album Let it Bleed,, affecting millions of lives, including mine. Fifty-three years later a song from that album, “You Can’t Always Get What You Want” still affects my life.

I was born in Colombia and named after my father, who has been pursuing his dreams all his life. I was raised by the loveliest family I could ever wish for, and the most supportive. At a young age, I realized that I could do whatever I wanted because no one ever told me anything was impossible. I loved swimming, playing tennis, playing violin, painting, and photography, among my hobbies. I had a hard time choosing what pathway to follow for life. I wanted to do something that could change the world.

At first, it was hard to let go of the fine arts interests I had to become a doctor. Then, I fell in love with many fields of medicine. It is true what the lyrics of prophet Mick Jagger said, “You can’t always get what you want. But if you try sometimes, you just might find, you get what you need.” What a bloody album, you might think. But the truth is, none of us can do all the craziest ideas we come with or pursue all the pathways that open for us. We have to, at some point, be smart and let go of some. Literature describes  soft and hard signs of bleeding, and the same could be said about success. Early signs that you might succeed in a field include becoming obsessed with it and loving it, which happened to me with surgery. Then I found I had an aptitude for surgical procedures. But the most crucial hard sign was fulfilling a more profound sense of identity. Surgical departments have personalities like the bands, and I have had the privilege of finding my perfect team. Quoting “With a Little Help from My Friends” by Lennon and McCartney, I discovered that I jump to begin new projects leaving behind some of them.

We know that in other regions of the world, such as in Colombia, conducting research is challenging. However, I was able to find a perfect storm under the mentorship of Andrea T. Obi, MD, at the University of Michigan as the 2023 Postdoctoral Research Fellow in vascular surgery and keep pursuing my dreams. I am here because I never thought anything was impossible; things just might take longer, and you will eventually make it. It is never easy to begin again in a new place, but there are indeed better things ahead than any we have left behind.   As philosopher Stevie Nicks sang with Fleetwood Mac on the 1977 Rumours album, “You can go your own way.”

I want to thank the mentorship of Andrea T. Obi, MD, Thomas Wakefield, MD, Peter Henke, MD, and Sriganesh Sharma, MD, PhD, and all the members of the Obi Lab for helping me to pursue my wildest research and surgical dreams.

DEI in the New Year

 

Kathleen Ozsvath, MD Membership Councilor, American Venous Forum Member, AVF DEI Committee 

 

 

 

Anil Hingaroni, MD Member, AVF DEI Committee Member, AVF Newsletter Committee

 

 

At the 2021 Annual Meeting, I grabbed my friend and colleague Dr Anil Hingorani. We sat down in front of my laptop to brainstorm about what DEI meant to us. Within a few short hours, we penned our plans, approached several friends and colleagues, including Dr Ruth Bush. Our goal was to ensure that the American Venous Forum would change the way individuals are chosen for tasks from speaking roles, committee memberships, panel members, etc. We also wanted to find ways to support our international membership and support the International Committee in their work. The leadership of the American Venous Forum encouraged and supported us to form the DEI committee so that this important work could begin. Together with our leader, Dr Ruth Bush, we were joined by several interested and thoughtful committee members, including Drs Misaki Kiguchi, Sebastian Cifuentes, Elna Masuda, Sheila Blumberg, Karem Harth, and supported by our administrative leaders, John Forbes and Jeff Mendola. We planned our first DEI session for the following 2022 Annual Meeting, which was a great success. This interest and excitement to provide a voice and include all of those interested continues to grow. AVF membership is 23% female. Of the 118 AVF members who serve on one or more committees, 43% are female. Committee chairs are 36% female. In a survey sent to members, the following results were obtained regarding race and sexual orientation.Both Dr Hingorani and I are personally honored to help Dr Marston and the AVF welcome the Sumner Keynote Speaker. Dr Donna Mendes trained both of us during our general surgery training. She was the first African American woman to become board certified in vascular surgery. Dr Mendes is a true trailblazer and has affected the careers of many! We must all work on creating environments that are inclusive, where diversity is celebrated, and where learning from one another’s differences makes the whole better. AVF is comprised of many diverse people who are joining together to carry forth the mission of the AVF.

Sexism in Research and Publishing: A Trend on Its Way Out

 

Andrea Obi, MD Chair, AVF Research Committee Member, AVF Newsletter Committee 

 

 

In the last decade increasing attention has been drawn to sex as a biologic variable (SABV). While human clinical trials have in recent times frequently involved men and women, sex was not routinely considered in preclinical study design and research often heavily relied on male animals. In 2016, the NIH began formally requiring that research design, analysis, and reporting in human and animal studies include SABV . The 5-year follow up of this initiative was published in 2020 in a paper published in the Journal of Women’s Health, “Sex as a Biological Variable: A 5-Year Progress Report and Call to Action.” (1)

Why is this important? Increasingly, it has been noted that the quality and completeness of medical research relies on taking sex into account. How can we expect that women will receive evidence-based disease prevention and treatment options if SABV is ignored? Addressing this issue is the overriding mission of the 2019-2023 Trans-NIH Strategic Plan for Women’s Health, which also aims to promote women in science careers to their full potential. In 2023, expect to see increasing accounting of SABV and inclusion of female animals in preclinical research.

References
1.ArnegardME, Whitten LA, Hunter C, Clayton JA. Sex as a biological variable: A 5-year progress report and call to action. J Womens Health (Larchmt) (2020) 29: 858-864.

2,800-Mile Step

 

Sebastian Cifuentes, MD Member, AVF DEI Committee Member, AVF International Committee Mayo Clinic, Rochester

 

 

“A wise man ought always to follow the paths beaten by great men, and to imitate those who have been supreme, so that if his ability does not equal theirs, at least it will savor of it.”

-Niccolo Machiavelli

The only constant in life is change. As years passed during medical training in Colombia, I realized that medicine, particularly vascular surgery, was more than a profession or a job. Instead, I conceived it to be a lifestyle and my utter purpose. Naturally, a definite purpose requires a thoughtful plan. The main questions I would ask myself were how and where I would reach my full potential to better serve my future patients, the specialty, and humanity. After extensive meditation, I decided to pursue my career in the United States.

Transitions are fueled by the passion for your goal and demand sacrifice and responsibility. Leaving behind my country and family meant taking a challenging 2,800-mile step out of my comfort zone. This added a bittersweet taste to the process; however, changes always bring opportunity. It has been more than 6 months since I started a research position in the US, and the shift has undoubtedly been propitious.

Through this new chapter, I am grateful for the memories, friends, experiences, and achievements that life has granted me. The work ethic, quality of clinical care, scientific rigor, and kindness of the working team has greatly exceeded my expectations and has made the foremost scenario to begin a career in the United States. In March 2020, just before the COVID-19 outbreak, I had the opportunity to attend the AVF Annual Meeting as a medical student for the first time. Since then, I have found a welcoming academic community in the American Venous Forum. The AVF has provided my peers and me an opportunity to solidify our passion for vascular surgery, build strong relationships with contemporaries and seniors, and actively participate in its committees and yearly congress.

For those of my dearest early-career peers, this endeavor is just starting, and the pathway ahead is long and exciting. I do not doubt that relentless effort and discipline will put us in the right place at the right time to bring wellness and hope to our future patients. Finally, Dr. William Mayo said, “No one is big enough to be independent of others.” I owe my present to the many who have enlightened the pathway, taught, and guided me through the most significant decisions. I want to take advantage of these short lines to thank DrJorge H. Ulloa and Dr Todd E. Rasmussen–innovators, leaders, and mentors whose steps have left positive marks on the lives of many.

Rethinking Thrombolytics and Stand-alone Anticoagulation in the Age of Advanced Mechanical Thrombectomy for the Treatment of Deep Vein Thrombosis

 

 

Venkat Tummala, MD Vascular Interventional Radiologist VP Medical Affairs, Inari Medical

 

 

Field experience and newly published data often precede official guideline modifications, with physicians contributing to a groundswell of change as they experience success with and adopt new technologies. Such is the case with mechanical thrombectomy for deep vein thrombosis (DVT) treatment, where a growing body of evidence supports the expanded use of newer therapies.

The ClotTriever® Thrombectomy System (Figure 1), a mechanical thrombectomy system designed to rapidly remove thrombus in a single session without the need for thrombolytics, has been used to treat more than 35,000 patients and is by far the most studied device to date with approximately 700 patients across 9 studies. (1-14) Results from the CLOUT registry, a 500-patient, prospective, all-comer study across 43 clinical sites, showed more than 90% complete or near-complete (>75%) thrombus removal (Figure 2A); 99% of cases were completed in a single session, with 0.0% incidence of major bleeding, valve or vessel damage, or acute kidney injury(11,12). Additionally, more than 90% of patients were free from moderate to severe post-thrombotic syndrome (PTS) symptoms at 30 days (11) and at 6 months (Figure 2B,C). (8) ClotTriever® has been shown to have none of the associated risks of bleeding from thrombolytics, excessive blood loss of continuous aspiration thrombectomy devices, or long-term procedure-related hospital and ICU stays.

To contextualize contemporary mechanical thrombectomy with historical treatment outcomes, a propensity-score matched analysis comparing results of CLOUT and the interventional arm of ATTRACT found that among 166 matched pairs, ClotTriever® produced superior thrombus extraction and lower Villalta scores at 30 days (Figure 2D-F). (13)

New tools to improve peripheral thrombus treatment continue to be developed. One such device is the Protrieve™ sheath (Figure 1), compatible with Inari platforms, which features a wall-apposing funnel designed to trap emboli during complex thrombectomy procedures involving the IVC. Another exciting new device that is now available is the InThrill™ Thrombectomy System (Figure 1), designed to remove acute to chronic thrombi and emboli in small 4-10mm vessels. The 8F system consists of a sheath with a recapturable, distal-braided funnel and a side port for aspiration, and a thrombectomy catheter with a self-expanding nitinol coring element.

Recently, success using InThrill™ as the front-line treatment to remove thrombus in the upper and lower extremities without significant blood loss or use of thrombolytics has been demonstrated.¹⁵ In a patient with thoracic outlet syndrome who presented with acute onset of left arm swelling and tightness, large pieces of highly organized thrombus in the left axillary and subclavian veins were removed using InThrill™. In another patient with complete occlusion of the left popliteal, femoral, and common femoral veins, InThrill™ was utilized to treat the below-the-knee and popliteal thrombus, which enabled left iliofemoral vessel access with ClotTriever®, and restored flow.

Conclusion

The new year is often a time to reflect on the past and take action to try new approaches. For DVT treatment, this means considering the breadth of data on innovative technologies with the potential to go beyond conservative therapies, leave high-risk thrombolytic treatments behind, and improve patient outcomes. New technologies in the Inari Medical toolkit should be part of this consideration, as they now make it possible to treat venous thrombosis throughout the peripheral vasculature.

Figure 1. Inari Medical Toolkit for treating thrombi and emboli in the peripheral vasculature.

Figure 2. A, data from the CLOUT registry show effective thrombus extraction as evidenced by reduced Marder Scores assessed by an independent core laboratory. (12) B,significant reduction in Villalta scores were seen at 30 days in the fully-enrolled, 500-patient CLOUT registry. (11) C, results at 6 months in the CLOUT registry 250-patient interim data set. (8)D-F, significant differences were seen in thrombus extraction and 30-day Villalta scores in a propensity-matched comparison of the CLOUT and ATTRACT interventional arm studies. (13)

References

1. Benarroch-Gampel J, Pujari A, Aizpuru M, Rajani RR, Jordan WD, Crawford R. Technical success and short-term outcomes after treatment of lower extremity deep vein thrombosis with the ClotTriever system: A preliminary sxperience. J Vasc Surg Venous Lymphat Disord 2020; 8: 174–181. https://doi.org/10.1016/j.jvsv.2019.10.024.
2. Zia S, Juneja A, Chadnick Z, Tan R, Neriah D, Singh K, Schor J, Deitch J. Provisional review and comparison of ClotTriever mechanical thrombectomy versus catheter directed and other mechanical thrombolysis and thrombectomy modalities for lower extremity deep venous thrombosis. J Vasc Surg 2020; 72: e243–e244. https://doi.org/10.1016/j.jvs.2020.04.403.
3. Irshad,A, Shah P, Jain AK, Gifford E, Ayach M, Gallagher J, Divinagracia T. Promising novel technique for percutaneous extraction of chronic lower extremity deep venous thrombosis: Clinical cxperience with the ClotTriever system. J Vasc Surg 2020; 72: e60–e61. https://doi.org/10.1016/j.jvs.2020.04.110.
4. Raskin A, Verma A, Brennan TD. Single-session thrombolysis-free treatment of deep vein thrombosis with a novel mechanical thrombectomy device. JACC Case Rep 2021; 3: https://doi.org/10.1016/j.jaccas.2020.12.049.
5. Shah NG, Wible BC, Paulisin JA, Zaki M, Lamparello P, Sista A, Sadek M, Jacobowitz GR, Maldonado TS. Management of inferior vena cava thrombosis with the FlowTriever and ClotTriever systems. J Vasc Surg Venous Lymphat Disord 2021; 9: 615–620. https://doi.org/10.1016/j.jvsv.2020.09.008.
6. Wadhwa V, Malhotra A, KesselmanA. Abstract no. 128. Rapid single-session mechanical thrombectomy of lower extremity deep venous thrombosis using the ClotTriever system: A single-institution experience. J Vasc Interv Radiol 2021; 32: S57. https://doi.org/10.1016/j.jvir.2021.03.134.
7. Jolly MA, Lockhart MM, Shah D, Huff CM, Valenti EA, Phillips JA, Bittar S, Botti CF, Kolluri R, SilverMJ. Outcomes from a tertiary care center using a catheter thrombectomy system for managing acute iliofemoral deep vein thrombosis. J Vasc Surg Venous Lymphat Disord 2022; 10: 1044–1050. https://doi.org/10.1016/j.jvsv.2022.04.010.
8. Dexter DJ, Kado H, Schor J, et al. Interim outcomes of mechanical thrombectomy for deep vein thrombosis from the all-comer CLOUT registry. J Vasc Surg Venous Lymphat Disord 2022; 10: 832–840. https://doi.org/10.1016/j.jvsv.2022.02.013.
9. Weissler EH, Cox MW, Commander SJ, Williams ZF. Restoring venous patency with the ClotTriever following deep vein thrombosis. Ann Vasc Surg 2022. https://doi.org/10.1016/j.avsg.2022.07.031.
10. Maldonado TS, Dexter DJ, Kado H, et al. Outcomes from the ClotTriever outcomes registry show symptom duration may underestimate deep vein thrombus chronicity. J Vasc Surg Venous Lymphat Disord. 2022;10:1251-1259. doi: 10.1016/j.jvsv.2022.04.015
11. Dexter D. In-hospital and 30-day outcomes from the fully-enrolled multicenter prospective CLOUT registry. Presented at: The VEINS; October 31, 2022; Las Vegas, Nevada
12. Dexter DDJ, Kado H, Shaikh ., et al. Safety and effectiveness of mechanical thrombectomy from the fully enrolled multicenter, prospective CLOUT registry. Journal of the Society for Cardiovascular Angiography and Interventions. In press.
13. Abramowitz S. Propensity-score matched analysis of early clinical outcomes from the CLOUT and ATTRACT studies. Presented at: The VEINS; October 31, 2022; Las Vegas, Nevada
14. Abramowitz S, Kado H, Schor J, et al. Six-month deep vein thrombosis outcomes by chronicity: Analysis of the real-world CLOUT registry. Journal of Vascular and Interventional Radiology. In press.
15. Kumar V, Khanna P. First reports on the novel InThrill thrombectomy system. Endovascular Today 2022.

Thromboprophylaxis: An Often-forgotten Part of Endovenous Intervention

 

 

Benedict R.H. Turner Section of Vascular Surgery, Charing Cross Hospital Imperial College London, London, UK

 

 

 

 

Matthew Machin Section of Vascular Surgery, Charing Cross Hospital Imperial College London, London, UK

 

 

 

 

Professor Alun H. Davies Section of Vascular Surgery, Charing Cross Hospital Imperial College London, London, UK

 

 

Endovenous intervention for varicose veins is an ambulant procedure and  is often thought to be associated with a low risk of venous thromboembolism (VTE) complications. However, the rate of deep venous thrombosis (DVT) is significantly higher compared to other day-case procedures of equivalent complexity and duration. The phenomenon may be due to perforator communications of deep and superficial lower limb veins that predispose patients to developing DVT or to endovenous heat-induced thrombosis (EHIT), which may result in associated morbidity through development of the post-thrombotic syndrome (PTS) and even mortality through embolization to the pulmonary vasculature. Deaths from pulmonary emboli (PE) after varicose vein procedures have been reported. As medical professionals, we can agree these are completely preventable deaths.

Depending on the series considered, the rate of DVT is seen to vary considerably. Our recent systematic review and meta-analysis considered the rate of DVT, PE, and major bleeding reported in published studies with the presence of pharmacological and mechanical thromboprophylaxis versus mechanical thromboprophylaxis alone. (1) We pooled data from 221 published articles; considering only the data from the 47 randomized controlled trials, the DVT rate with additional pharmacological thromboprophylaxis is more than 4 times lower (0.52%) (1095 patients, 2 events) than with mechanical thromboprophylaxis alone (2.26%) (6951 patients, 69 events). Interestingly, subgroup analysis demonstrated no differences in the DVT rate between the treated vein (great/ short/ anterior accessory saphenous) nor in the endovenous treatment modality utilized (cyanoacrylate glue/ endovenous laser/ foam sclerotherapy/ mechanochemical/ radiofrequency). Further, there were no differences between a single peri-operative dose of antithrombotic medication versus an extended course (range 2-13 days) post-operatively. Importantly, data were pooled from trial arms and there were no randomized trials that compared head-to-head pharmacological and mechanical thromboprophylaxis versus mechanical thromboprophylaxis alone.

The review did not address the actual role of compression therapy after endovenous interventions for varicose veins. UK national guidelines, as well as some manufacturers, recommend graduated compression stockings (GCS) for one week after endovenous ablation. The role of compression here is theoretically multiple: as an adjunct for venous closure; to reduce post-procedural swelling and pain;  and as a form of mechanical thromboprophylaxis. (2) However, a systematic review of the efficacy of GCS in addition to pharmacological thromboprophylaxis undertaken by the authors (and currently under peer review) has demonstrated no additional benefit of GCS, in line with the results of the GAPS trial. (3, 4) While the immediate application of compression bandaging for procedural efficacy and post-procedural pain is warranted, can we really recommend the prolonged prescription of GCS?

The above information has led to the establishment of an NIHR-funded trial to look at the benefits of pharmacological thromboprophlaxis in patients undergoing endovenous treatment for varicose veins. Pending the results of this study, we would recommend formal assessment of patients with a risk assessment tool and VTE prophylaxis decisions should be based on this. Patients need to be made aware of the risk of VTE.

References

1. Turner BRH, Machin M, Jasionowska J, et al. Systematic review and meta-analysis of the additional benefit of pharmacological thromboprophylaxis for endovenous varicose vein interventions. Ann Surg2022; Sep 15. Epub ahead of print. PMID: 36205129
2. Bootun R, Belramman A, Bolton-Saghdaoui L, et al. Randomized controlled trial of compression after endovenous thermal ablation of varicose veins (COMETA rrial). Ann Surg. 2021;273:232-239.
3. Turner BRH, Machin M, Jasionowska J, et al. Systematic review and meta-analysis of graduated compression stockings in addition to pharmacological thromboprophylaxis for surgical inpatients. Unpublished,
4. Shalhoub J, Lawton R, Hudson J, et al. Graduated compression stockings as adjuvant to pharmaco-thromboprophylaxis in elective surgical patients (GAPS study): randomised controlled trial. BMJ. 2020; 369:m1309.