In-hospital mortality for elderly patients with atrial fibrillation (AF) undergoing percutaneous left atrial appendage closure (LAAC) is not different from that of younger patients, Cleveland Clinic researchers have found in a nationwide database analysis. Although periprocedural complications and 30-day readmissions were higher in patients aged 80 years or older relative to younger patients, rates were low enough to make LAAC an acceptable alternative to long-term anticoagulation in older patients who would benefit from the procedure, they concluded.
Cleveland Clinic is a non-profit academic medical center. Advertising on our site helps support our mission. We do not endorse non-Cleveland Clinic products or services Policy
“We were encouraged that the rate of complications was low, with a relatively small difference in absolute event rates between the two age groups,” says Samir Kapadia, MD, Chair of Cardiovascular Medicine and senior author of the study, published in the Journal of the American Heart Association (2022;11:e024574). “LAAC may be performed safely in the very elderly and should be considered on a case-by-case basis, weighing the risks and benefits of this intervention in light of available evidence.”
Filling the information gap
LAAC has gained acceptance as an alternative to long-term anticoagulation for stroke prevention in patients with AF who have a contraindication for long-term oral anticoagulation. However, data on LAAC in the elderly have been sparse. The Cleveland Clinic researchers sought to fill this gap by conducting a retrospective review of outcomes of more than 13,000 adults in the Nationwide Readmissions Database who underwent LAAC from the beginning of 2016 through the end of 2018.
While mortality rates in patients aged 80 or older were comparable to those in patients younger than 80 (0.32% vs. 0.21%; P = 0.236), older patients had a higher risk of periprocedural complications, including stroke/transient ischemic attack, bleeding requiring transfusion, vascular complications, systemic embolization and pericardial effusion/tamponade requiring pericardiocentesis or surgical intervention. However, the rate of complications was low, with relatively small differences in absolute event rates between the age groups.
While the older patients were more likely than their younger counterparts to be readmitted within 30 days (9.9% vs. 8.4%; P = 0.004), there was no significant difference between groups in major complication rates at 30 days.
Interpreting the results
Cleveland Clinic electrophysiologist Walid Saliba, MD, who did not participate in the analysis, calls the findings “encouraging.”
“The risk of complications is only a little worse in patients over 80 than in patients who are not yet 80,” says Dr. Saliba, “which is reassuring since older patients have more comorbidities and tend to be relatively frail. Bleeding complications were the main cause of readmissions within 30 days in those 80 or older, and this likely reflects the increased bleeding risk associated with advanced age, as well as the need to continue taking anticoagulants for 45 days following LAAC in this patient population with a relative contraindication for long-term oral anticoagulation.”
Dr. Saliba adds that the study is notable “because it does not raise red flags about considering this procedure in elderly patients.” He says this aligns with current experience at Cleveland Clinic, where around 35% of patients undergoing LAAC are older than 80. “Our experience echoes this study in indicating that LAAC, specifically with the Watchman™ device, is predominantly feasible and relatively safe to consider in elderly patients.”
Multiple risk factors involved
According to Dr. Saliba, age is only one risk factor that should be weighed in the decision around performing LAAC. Comorbidities that could counteract the benefits of LAAC must be considered as well.
One such comorbidity is end-stage renal disease (ESRD), which the researchers found to be an independent risk factor for mortality in patients aged 80 or older undergoing LAAC. “If you have a patient with ESRD or on hemodialysis, you might want to rethink whether LAAC is appropriate, and such decisions should be made on a case-by-case basis,” Dr. Saliba cautions. He adds that the presence of significant carotid artery disease should also give pause in this setting since the patient’s risk of stroke would remain elevated even after LAAC.
In patients over 80 with multiple comorbidities, life expectancy also should be considered. “LAAC is a therapy that provides benefit over time,” Dr. Saliba says. “If a patient is only expected to live about a year or less, they probably don’t need this procedure.”
On the other hand, an older patient with AF who cannot be on oral anticoagulants has a high risk of stroke, “and strokes from AF are bad strokes,” Dr. Saliba continues. “So, even if a patient is older, if they are expected to live longer than a year and their risk of stroke is 5% to 7% per year, that patient would be better served by trying to avoid a stroke, even if there is a small risk of complications from the procedure. Patients like this are likely to benefit from LAAC, provided they don’t have a significant comorbidity.”
More data needed on postprocedural anticoagulation
Although LAAC is performed to avert the risks associated with long-term anticoagulant use, FDA-approved labeling for the Watchman device calls for 45 days of anticoagulation following LAAC. A transesophageal echocardiogram is then performed. If the LAAC device is properly positioned without blood leaks around it and with no thrombus formation on top, the procedure is considered successful and anticoagulant therapy may be replaced with clopidogrel and aspirin for a total of six months after the implant, followed by aspirin alone thereafter.
But this should be viewed as guidance, Dr. Saliba notes, as clinicians commonly use their judgment about extending or reducing the duration of anticoagulant therapy when the risk of clotting or intracranial bleeding is very high.
“These are guidelines, not mandates,” he says. “There is potential for great variability in the postprocedural drug regimen. Additional prospective studies are needed to determine the ideal anticoagulation and antiplatelet regimens, especially in very elderly patients with elevated bleeding risk. Moreover, newer devices are being developed with the aim of simplifying the postprocedure drug regimen, potentially even obviating the need for postprocedural short-term oral anticoagulation.”