FDA issues safety notice on Lariat LAA occlusion 7/13/15

Just noticed it at HRS website.

[www.fda.gov]

Yep came out two days ago, and the issue was fully discussed at ISLAA International Symposium on Left Atrial Appendage in February.

The concensus is that its true too many EPs with little to no dry stick pericardial access experience and/or interventional Cardios with little to no experience working with the LAA in general jumped in too soon to do these new procedures as every hospital was rushing to offer Lariat two and a half years ago when it first got popular.

The 6 deaths were really unfortunate and a shame, and such new roll out phase procedures should be restricted at first to more experienced operators with each phase of the process. Lariat has multiple phases a few of which are in the domain and a few more suited to a cardiac surgeon or interventional cardio. It takes around a dozen of those at least for those EPs who have no experience with it to get real comfortable with performing a dry PC stick to access the pericardium epicardially. But most all
all of these very serious and even tragic complications came with first second or third time Lariat installers from what was discussed at the ISLAA with docs there offering a list of steps to take to insure those injuries don't happen again with the Lariat.

Plus Sentraheart has redesigned the Lariat to make the Epicardial catheter control
Arm more flexible and stronger too with a braided tube that allows the Doc to bend or arch the catheter above and over the little RVOT (right ventricular outflow tract) ridge on the outside of the right ventricle just above from, and across the pathway of, where the lower pericardial access is made to prevent nicking or tearing a hole in the right ventricle (that will spoil your day!) as they snake the Epicardial catheter up through the narrow PC space to the tip of the LAA.

Too many of these procedures were done early on by even just moderately to minimally experienced AFIB ablationists and as such the vast majority of these 45 more serious LARIAT adverse events .. including 6 of the most serious possible consequence ... were done by docs over their head.

There are a could inherent issues with the Lariat too, as I found out first hand .. with the small but still there inherent potential for late leaks , which is not something that can happen with the Atriclip, for example.

But even when everything is done perfectly in a LARIAT procedure as was done in my case, roughly 5 percent of Lariat patients are likely to experience leaks larger than 3mm diameter and thus large enough to re-establish bi-directional blood flow between the LA and remnant LAA pouch, and thus make for the potential for a stroke as I had with a 5mm diameter leak from my Lariat even after having two early post Lariat TEE's confirm that it was all sealed up.

Alas, that was with 2D TEEs, and my experience was the first to confirm that a 3D TEE is required when both performing Lariat installs and especially for follow up testing which also should be done every 3 months for the first year at least to insure that they will catch any larger leaks if one should develop and plug those necessary and/or restart OAC drugs for as long as needed to insure smaller leaks are fully endothelial-ized and thus seal up on their own over time.

Keep in mind though, that most of these peri-procedural complications were due to the marketing rush of too many hospitals and EPs jumping on the bandwagon without having the staff and experience with both endocardial and epicardial access to perform the procedure reasonably safely.

The vast majority of Lariat procedures went off without a hitch, but it density take more than a few real disasters ... like a few who had they entire LAAs ripped off by over eager tugging trying to dislodge the two magnetic tipped guide wires, one tip of which has a sharp edge that has since be corrected in the new Lariat Plus system.

Nevertheless, as we discussed here last February and March, the recommendation for those needing LAA closure for now is to go for either the epicardial-only minimally invasive Atriclips approach with an experienced Cardiac Surgeon who knows all about installed the clip with the minimal invasive method .. Or go with the now FDA approved Watchman if the main aim is to get off OAC.. and particularly if you already have had a solid LAA isolation that has stood the test of time at least a year and is likely good to go so that you don't likely need the added insurance of robust LAA electrical isolation that the Atriclip ( or Lariat for that matter) do provide along with the LAA vascular isolation as well.

As usual, this FDA Bulletin comes long after the Cardio/EP community has largely already digested all this info and have adjusted their practices accordingly.

With over 45,000 Atriclip installations to date, most of which were done with on bypass pump open heart surgery as part of either a valve replacement or a full on surgical maze or a CABG operation where the person had AFIB or was highly likely to develop it after the surgery, But also a large number of these have no been done as stand alone Atriclip minimal invasive procedures too and so far not one serious adverse event had been reported anywhere as of this past February.

Dr Natale prefers this approach too now when full ligation is the best overall bet for a given one of his patients.

Shannon



Edited 1 time(s). Last edit at 07/17/2015 01:37PM by Shannon.

FYI - Shannon has posted there are better, safer options for closing off the LAA and when required, should be recommended by one of the knowledgeable elite EPs who are out front on which devices to use for this procedure.





Lariat Suture Delivery Device for Left Atrial Appendage (LAA) Closure by SentreHEART: FDA Safety Communication - Reports of Patient Deaths and Other Serious Adverse Events
July 13, 2015
Food and Drug Administration (US)

AUDIENCE: Cardiology, Internal Medicine, Risk Manager

ISSUE: FDA is alerting health care providers and patients of reports of patient deaths and other serious adverse events associated with the use of the Lariat Suture Delivery Device and its associated devices to close the left atrial appendage, a pouch-like region of the left atrium in the heart, in patients with irregular heart rhythm (atrial fibrillation) to prevent stroke.

FDA identified 45 adverse events through June 30, 2015 that occurred in patients undergoing LAA closure procedures with the Lariat Suture Delivery Device and/or its associated devices. These reports describe 6 patient deaths and other serious medical complications including laceration and/or perforation of the heart, complete LAA detachment from the heart, bleeding (hemorrhage), low blood pressure (hypotension), fluid collection around the heart (pericardial effusion), fluid collection around the heart that causes low blood pressure and decreased heart function leading to shock (cardiac tamponade), and fluid collection around the lung (pleural effusion). Of the 45 adverse events reported to the FDA, 34 (approximately 75%) resulted in the need to perform emergency heart surgery.

The FDA will continue to monitor this issue and keep the public informed if significant new information becomes available.

BACKGROUND: Some physicians are using the LARIAT Suture Delivery Device along with three other cleared associated SentreHEART devices (the EndoCATH Occlusion Balloon Catheter, the SofTIP Guide Cannula, and the FindrWIRZ System) to close the LAA. The FDA has not evaluated the use of the Lariat Suture Delivery Device for LAA closure to reduce the risk of stroke in atrial fibrillation patients.

RECOMMENDATION: Health professionals should be aware that the safety and effectiveness of the Lariat Suture Delivery Device to close the LAA and prevent stroke in patients with atrial fibrillation has not been established. See the FDA Safety Communication for recommendations for patients and additional information.

To reduce the risk of stroke in patients with atrial fibrillation, consider treatment options for which safety and effectiveness have been established. Prior to treatment, inform atrial fibrillation patients of the benefits and risks of the available treatment options to help prevent stroke.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Thank You Jackie,

Check! No Lariat for me, should I need LAA closure.

I count myself as a former persistent afibber who is now under the care of Dr. Natale. I am presently awaiting a date for my second ablation with the Maestro in Austin. This will be my fourth ablation, the first two were done by a well meaning EP here in Florida who heavily advertised himself as an "expert" in treating persistent afib., yada yada yada. While Dr. Natale was doing my first ablation with me in February, '15, he discovered that my pulmonary veins had not even been isolated after 2 ablations with the "expert" in Florida. Bummer!

With my first ablation in Austin, Dr. Natale was able to do a lot to quiet my quivering left atrium. Taking the conservative approach, he ablated around my LAA without doing a complete isolation. Now, I am faced with a flutter circuit that will be addressed with my second ablation in Austin. At that time, he may choose to isolate my LAA. If so, I will travel down that decision tree to the possibility of choosing an LAA closure technology with a doctor recommended by Dr. Natale. I believe Dr. Natale favors the AtriClip at this time, done by a recommended cardiac or thoracic surgeon. I am very grateful to Dr. Natale and his Stellar team.

John

Hello John - I can certainly relate to your situation, as all my ablations were done by Dr. Natale.... The Natale ablation #2 did require LAA isolation and then he also did a touch up there this past April. So, in another 3 - 4 months, I'll be evaluated to learn if I can go off Eliquis or will have to consider another procedure. It's my understanding also that Dr. N prefers the AtriClip and a specific surgeon to do it...but it's still less than appealing to think about yet another procedure, so I'm holding out the best possible positive thoughts that I'll win the LAA lottery and it will not need further attention.

I share your enthusiasm for Dr. Natale and his team. I found the Austin experience outstanding. I wish you well for #4. Let us know the date so we can send you an abundance of positive energy and good thoughts.

Best to you,
Jackie

Will do, Jackie.
Thank you for your continued presence and contributions to this community.

John