The document was designed to promote standardization and identify future research goals in this rapidly-growing field.
With more than 15 years of evidence and the continuing evolution of devices, the Society for Cardiovascular Angiography and Interventions (SCAI) and the Heart Rhythm Society (HRS) have released practice guidelines for stroke prevention with left atrial appendage occlusion (LAAO) in patients with nonvalvular atrial fibrillation (AF).
The document, published online today in both JSCAI and Heart Rhythm Journal, follows an expert consensus paper published by the two societies in 2023. It was designed to standardize an ever-growing practice and identify knowledge gaps, writing committee chair Andrew Goldsweig, MD (University of Massachusetts-Baystate, Springfield), told TCTMD.
The US Food and Drug Administration approval of LAAO with the Watchman device (Boston Scientific) in 2015 was based on studies that are now “outdated,” as medical therapy and imaging technology have advanced, Goldsweig said.
“There’s really tremendous diversity in LAAO practice, especially between interventional cardiologists and electrophysiologists, [as well as] diversity regarding which patients are appropriate, what periprocedural imaging is appropriate, what adjunctive medical therapy is appropriate, [and] how peridevice leak or device-related thrombus should be managed,” he commented.
With more than 100,000 LAAO cases performed in the United States last year, and a patient population that’s likely to grow, according to Goldsweig, it was time for the field to codify practice to be able to move forward in an evidence-based fashion.
The Highlights
The new guidelines include recommendations drawn from more than 3,700 studies. One of the first major issues addressed is whether to send patients for LAAO or to maintain oral anticoagulation. While the guidelines recommended LAAO over no therapy in patients with contraindications to oral anticoagulation, the two options are “sort of equivalent partners” in the general AF population as of now, said Goldsweig.
If LAAO has been decided, preprocedural imaging is recommended conditionally due to a low certainty of evidence, “but there are in fact data to suggest that preprocedural transesophageal echocardiography or CT imaging results in better outcomes,” Goldsweig said. The same goes for intraprocedural imaging with either transesophageal echocardiography (TEE) or intracardiac echocardiography (ICE).
Notably, the FDA released an alert today regarding the risk of air embolism during sheath insertion of Watchman procedures in patients under sedation.
“With ICE guidance, patients are typically under conscious sedation, breathing independently, and therefore do not have positive-pressure mechanical ventilation,” Goldsweig explained. “The FDA alert does not change the guidelines’ recommendation, which is based upon equivalent outcomes with ICE and TEE guidance. However, the warning does underscore the importance of de-airing catheters rigorously, especially in ICE-guided procedures.”
Following the procedure, the experts highlight competing risks of bleeding and stroke when considering anticoagulation or dual antiplatelet therapy (DAPT). There is a conditional recommendation for either option, with those who have significant contraindications to anticoagulation “reasonably” going with DAPT. Goldsweig said this area has substantial knowledge gaps, especially regarding the role of single antiplatelet therapy, that should hopefully be addressed in the ongoing SIMPLAAFY trial.
Regarding postprocedural imaging, there’s a conditional recommendation with a very low certainty of evidence in favor of performing either TEE or CT.
Another unknown is how to treat patients with peridevice leak (PDL). “We know that some percentage of patients will have a peridevice leak, and we don’t know how best to manage it,” Goldsweig said. “Should those patients be anticoagulated? At what frequency should they undergo imaging? Should we be putting plugs in those leaks? We don’t know. But by identifying that as a knowledge gap, hopefully we will promote future research in that area.”
Lastly, the issue of what to do about device-related thrombus (DRT) remains unclear. “We do have data showing a stroke risk associated with DRT that is mitigated by anticoagulation,” Goldsweig said. “So, the panel did recommend anticoagulation for DRT but makes no recommendation about the duration or timing of repeat imaging following DRT.”
Goldsweig praised the multidisciplinary team behind the guidelines, which included interventional cardiologists, electrophysiologists, cardiovascular imaging specialists, and methodological experts. He said SCAI plans to update the document in the next 3 to 5 years.