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2019 AF Symposium: Vascular Closure Device-Great News for Ablation Patients!

When one gets a catheter ablation, often the most annoying part of post-op is having to lie still on one’s back for 6 hours while the insertion point(s) in the groin stops bleeding and heals enough to go home. (For guys, especially, it’s no fun having to use a Foley catheter to pee.) The risk of bleeding from the puncture site(s) is an all-too-common complication that can affect up to 20% of ablation procedures.

A Solution: VASCADE MVP Vascular Closure Device

Delivery disc of the VASCADE MVP inserts the collagen plug

Cardiva Medical has solved this problem. A simple, ingenious device closes off the insertion point(s) in the groin to stop any bleeding.

How it’s used: After completing the ablation, the EP withdraws the ablation catheter, then replaces it with the VASCADE MVP which has a expandable/collapsible delivery disc to implant a collagen plug. This plug or patch stops all bleeding leakage. (The FDA was so impressed with the VASCADE that it approved it within weeks.)

I give it a try: In the Exhibitors Hall, Michael Gebauer of Cardiva Medical demonstrated it to me. It takes a whole 5 seconds to insert the VASCADE MVP.

The tip expands into a disc which stops all blood flow. The collagen plug is located just behind the tip of the disc. It expands as blood from the surrounding tissue fills it blocking off the catheter insertion point.

Then after around 30 seconds, the tip is collapsed and closed up and the device removed. (It’s so simple and easy to use, I could probably do it.)

After about 30 days, the collagen plug naturally dissolves by itself. Nothing is left behind.

Spotlight Session

In the Spotlight Session Thursday morning and at a lunch meeting, doctors Amin Al-Ahmed, Andrea Natale and Suneet Mittal described the VASCADE MVP and the AMBULATE randomized clinical trial. (Link to the AMBULATE trial results)

In the clinical trial, the VASCADE MVP was compared to standard post-op care where a nurse had to apply pressure on the groin insertion site(s) to make sure bleeding or leakage didn’t occur, sometimes for as long as 6 hours. EPs also used a figure-8 suture to close off each insertion site. But the patient still needed 6-8 hours of bed rest and could still bleed through the sutures especially if they had to cough. And removing the sutures was painful.

AMBULATE Clinical Trial

The Cardiva Medical VASCADE MVP

Ambulatory after 1 hour: Patients receiving the VASCADE were able to walk around after about an hour. They also didn’t need pain meds to help them stay still for 6 hours, which was previously required after a catheter ablation (58% reduction in need for pain meds).

Less staff time and less meds: Nursing staff saved time not having to apply pressure to the patient’s groin site(s). The drug Protamine, which previously had to be used to counteract the effects of blood thinners administered during an ablation, was no longer necessary.

Substantial cost reduction: Each VASCADE device costs around $200-$250, which is considerably cheaper that the normal $1,000-$2,000 costs associated with standard post-op care.

Sooner patient discharge: It’s estimated that patients may no longer have to stay overnight to monitor their groin insertion sites but may be able to go home the day of their ablation. (But patients may need to stay longer than an hour to get over the effects of the anesthesia and wake up fully.)

Session presenters: Doctors Al-Ahmed and Andrea Natale are with Texas Cardiac Arrhythmia Institute in Austin TX, and Dr Suneet Mittal is with Arrhythmia & Cardiology Consultants, Paramus, NJ.

VIDEO: Cardiva® VASCADE MVP Vascular Closure Device Animation. Insertion device for collagen plug. 1:30 min.

Increased Satisfaction: Doctors, Staff and Patients

Dr. Natale described how he and all of his 10 fellow EPs at the Texas Cardiac Arrhythmia Institute quickly chose to change their established protocols and now use the VASCADE MVP . (Link to the AMBULATE trial results)

The nursing staff, he reported, appreciate the time saved not having to manually apply pressure to the patient’s groin.

And the patients are happy with use of the VASCADE MVP because they can go home sooner, and lying on one’s back for 6 hours is hard and sometimes painful. Male patients appreciate less time having to endure a Foley catheter to pee. No issues have arisen with the 1,000 patients who have been treated with the VASCADE MVP.

Editor’s Comments
Though the VASCADE MVP device may at first not seem like a big deal, it really is!
I just got off the phone with Andy who was telling me about his RF Ablation and his post-op experience. He had to lie on his back for 15 hours before his groin incision stopped bleeding and he was safe to go home. He said it was quite painful to be immobile that long.
I predict that the VASCADE will be rapidly adopted by most centers doing catheter ablations.
It’s simple to use, it greatly increases patient satisfaction, it may shorten the time a patient has to stay in a hospital, nursing and lab staff are happier and can do more productive work, EPs have one less thing to worry about, and it’s relatively inexpensive compared to standard post-op care.
(But one EP leader I talked to at the Symposium said he continues to use the figure-8 suture and isn’t about to switch to the VASCADE.)
From a patient’s perspective, the VASCADE MVP is probably the most important presentation at this year’s AF Symposium.
References for this article
AMBULATE study of VASCADE MVP system meets primary endpoint. Cardiac Rhythm News. 16th November 2018.  https://cardiacrhythmnews.com/vascade-mvp-meets-primary-endpoint/

The AMBULATE Trial: A Randomized, Multi-center Trial to Compare Cardiva Mid-Bore VVCS to Manual Compression in Closure of Multiple Femoral Venous Access Sites in 6 – 12 Fr Sheath Sizes (AMBULATE). ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03193021

Duytschaever, M & Ernst, S. Combining practical and scientific learning to meet educational needs at Europe’s largest atrial fibrillation symposium. Cardiac Rhythm News, March 2019, Issue 44, p. 7.

If you find any errors on this page, email us. Y Last updated: Saturday, April 13, 2019

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