By Will Boggs MD
NEW YORK (Reuters Health) - 6/6/2019
"The LSPAF group may represent a high-risk group and should be followed closely beyond the 45-day time point to see if these leaks are stabilizing or getting larger, which would have important clinical implications for the patient and the implanters," Dr. Gagan D. Singh of the University of California, Davis, told Reuters Health by email.
LSPAF has been associated with increased left atrial volume, and left atrial dilatation and large LAA dimensions have been linked to an increased risk of stroke. The effect of LSPAF on LAA ostial size and depth in relation to device-size selection and procedural outcomes remains unclear.
Dr. Singh and colleagues compared outcomes between patients with and without LSPAF undergoing Watchman LAA occlusion in their retrospective study of 101 consecutive patients. The average LAA depth and average LAA ostial diameter and depth were significantly larger in the 48 patients with LSPAF than in the 53 non-LSPAF patients, but there was no difference in the number of lobes or the shape of the LAA between the groups.
Patients with LSPAF required significantly larger device sizes than did patients without LSPAF, but device compression was similar between the groups.
Immediately after device implantation, four LSPAF patients and one non-LSPAF patient (9% vs. 2%, P=0.14) had measurable leak. At the six-week follow-up, 21 LSPAF patients and 13 non-LSPAF patients (48% vs. 25%, P=0.04) had any residual leak. During median follow-up of 422 days, the groups did not differ in the incidence of death, stroke, or myocardial infarction.
"We cannot draw any definitive conclusions from the data, but the findings are thought provoking (i.e., hypothesis generating), and I think should alert the community of implanters to think about studying this group of patients in a more formal prospective setting with longer imaging follow-up," Dr. Singh said.
Dr. Adel Aminian from Centre Hospitalier Universitaire de Charleroi, in Belgium, who co-authored an accompanying editorial, told Reuters Health by email, "LAA occlusion is a challenging procedure due to the extreme variability in LAA shape and dimensions. Accurate preprocedural assessment of LAA anatomy by 3D imaging modalities represents, in my opinion, the way to increase the procedural success. In this setting, the presence of LSPAF may represent a risk factor for larger and more complex LAA anatomies warranting detailed pre-procedural assessment."
"Although the study shows an increase in 'moderate' peridevice leak (PDL) in LSPAF patients following Watchman implantation, the clinical significance of moderate leaks remains unanswered, and, based on current evidence, it has not been shown to increase the ischemic risk," he said. "However, as the ultimate goal of LAA occlusion is to exclude as far as possible the LAA from the circulation, operators should aim to decrease the incidence of PDL to minimal level achievable."
In the second study, to appear along with the first in the June 10 issue of JACC: Cardiovascular Interventions, Dr. Lukas Hobohm of University Medical Center Mainz, in Germany, and colleagues used data from a German nationwide inpatient sample of more than 15,000 procedures to evaluate five-year in-hospital trends and safety outcomes of LAA closure.
The number of LAA occlusions annually increased from 1,347 in 2011 to 4,932 in 2015, during which hospital mortality increased slightly but not significantly from 0.5% in 2011 to 0.9% in 2015.
Important independent predictors of in-hospital death included acute renal failure, pericardial effusion, and ischemic stroke during hospitalization. Other factors independently associated with five-fold or greater odds of in-hospital death included transfusion of erythrocyte concentrates, pulmonary embolism, pericardial puncture, shock and cardiopulmonary resuscitation.
"We detected a 3.6-fold increase in the use of LAA closure procedures between 2011 and 2015 without significant change regarding the in-hospital mortality in the German large nationwide sample," Dr. Hobohm and co-authors Dr. Tomasso Gori and Dr. Karsten Keller told Reuters Health in a joint email. "This is surprising, since the treated patients grew older during the observational period."
"Our study demonstrated important predictors of in-hospital death during hospitalization for LAA closure, which might be relevant for better patient selection to reduce adverse events," they concluded.
"Ongoing clinical trials are investigating the value of LAA closure in patients with contraindications to oral anticoagulation (ASAP-TOO) and in comparison with direct oral anticoagulation in the setting of high bleeding risk (CLOSURE AF)," write Dr. Boris Schmidt and Dr. Julian Chun from AGAPLESION Markus Krankenhaus, in Frankfurt am Main, Germany, in a related editorial.
"These studies will hopefully improve our ability to appropriately select patients who benefit from LAA closure and to identify patients in whom we may defer an interventional approach," they add.
Boston Scientific, which sells the Watchman device, had financial ties to authors of both reports.
JACC Cardiovasc Interv 2019.
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