BALTIMORE, MD — Transesophageal echocardiogram may not be necessary for all patients undergoing catheter ablation for atrial fibrillation (AF) while on uninterrupted apixaban (Eliquis, Bristol-Myers Squibb/Pfizer) or rivaroxaban (Xarelto, Bayer/Johnson & Johnson), new research suggests.
Overall, one (0.10%) thromboembolic event occurred in a patient on rivaroxaban with persistent AF.
Two (2.3%) silent cerebral ischemia (SCI) were identified using brain diffuse MRI in a subset of 86 patients.
"This is the first prospective, multicenter study showing that performing AF ablation while on uninterrupted [novel oral anticoagulants] NOACs without TEE is feasible and safe," the investigators write in their paper, published online March 16, 2016 in Heart Rhythm.
The study validates prior reports suggesting that TEE is not warranted in patients at low risk for thrombus.
The authors contend that it provides new evidence that AF ablation without preprocedural TEE is also feasible and safe in a high-risk population, including patients with nonparoxysmal AF (84.9%) and high risk for stroke (average CHA2DS2VASc score 3.01 and CHADS2 score >2 in 62.8%).
"You can avoid doing TEE if you are on [anticoagulants] for 4 weeks or more as long as you use intracardiac echo," lead author Dr Luigi Di Biase (Montefiore Medical Center, Bronx, NY, and Texas Cardiac Arrhythmia Institute at St David Medical Center, Austin) told heartwire from Medscape.
Commenting on the findings, Dr Jagmeet Singh (Massachusetts General Hospital, Boston, MA) said the study allays some of his anxiety when taking an AF patient for a procedure who has a low CHA2DS2VASc score and he decides not to do a TEE but expressed reservations about using a "one-size-fits-all" approach.
"I'm afraid the results of this might get generalized to even high-risk substrates," he told heartwire . "That's why I think folks may need to interpret this cautiously and still individualize the strategy depending on if patients have had a history of stroke, a prior clot, or congestive heart failure."
All 970 patients in the registry study were on anticoagulation for at least 4 weeks before ablation, with 514 patients on apixaban 2.5/5 mg twice daily and 456 patients on rivaroxaban 15 to 20 mg daily.
Using intracardiac echo, the left atrial appendage (LAA) was visualized in 71% of patients.
"The fact that you don't see the left atrial appendage in almost one-third indicates that it's not as good a strategy in all hands," Singh said.
While many cardiologists can do an intracardiac echo and see the left atrial appendage every time, not everyone is very facile with intracardiac echocardiography, and there is a variability of experience out there, even in confirming the presence or absence of clot, unless it's really evident. That's where doing a TEE a priori in high-risk subsets makes sense because the clinician can abort the procedure, Singh said.
In the study, the procedure was continued regardless of whether the LAA was visualized or not. "It automatically suggests some degree of bias that they were already committed to the procedure," he added.
Di Biase said intracardiac echo is already used at many centers during complex ablation and can save patients time by avoiding delays waiting for a TEE to be performed. There also have been reports of TEE-related injuries including laryngeal, esophageal, and gastric injuries and gastric bleeding.
Major bleeding (pericardial effusion) was reported in six patients (0.62%) in the study and minor bleeding in 10 (pericardial effusion 0.62%; groin hematoma 0.41%).
While the study provides much-needed data on anticoagulation with factor Xa inhibitors, Di Biase said the results should not be extrapolated to class II inhibitors such as dabigatran (Pradaxa, Boehringer Ingelheim).
Another limitation, both men agreed on, is the reliability of NOAC adherence.
"With Coumadin, no matter what the patient says, you measure it and if you have four good measurements, you're good," Di Biase said. "With NOACs, you have to trust the patient that they are taking this for 4 weeks, every day, but is it true or not?"
Di Biase is a consultant for Biosense Webster, Stereotaxis, and St Jude Medical and has received speaker honoraria/travel fees from Boston Scientific, Medtronic, Janssen, Pfizer, Bristol Myers, EPiEP, and Biotronik. Disclosures for the coauthors are listed in the article. Singh reported no relevant financial relationships.
Heartwire from Medscape © 2016 Medscape, LLC
Cite this: Transesophageal Echo Questioned With Uninterrupted NOACs in AF Ablation - Medscape - Mar 29, 2016.