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Device repositioning, depressed LVEF may predict early outcomes after LAA closure
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Within 1 week of left atrial appendage closure with an Amplatzer device, the rate of early procedural success was high and major adverse events were low. Predictors of early safety events included device repositioning and depressed left ventricular ejection fraction, researchers reported in JACC: Cardiovascular Interventions.
“Catheter-based [left atrial appendage closure] is increasingly recognized as a valuable treatment option for stroke prophylaxis in patients with [atrial fibrillation]; however, concern has been raised regarding the procedural safety of this preventive intervention. In the present study ... we found high early procedural success and rates of major complications that are comparable with those found in previous observational studies with Amplatzer devices,” Konstantinos C. Koskinas, MD, MSc, from the cardiology department, University Hospital of Bern, Switzerland, and colleagues wrote.
The prospective observational registry enrolled consecutive patients undergoing left atrial appendage (LAA) closure from 2009 to 2014 at two centers in Switzerland. The current analysis focused on 500 patients with AF deemed ineligible or at high risk for oral anticoagulation who underwent LAA closure with the Amplatzer cardiac plug (St. Jude Medical; n = 408) or the Amplatzer amulet (St. Jude Medical; n = 92). The mean age of the patients was 74 years, and 30% of the patients were women.
The rate of early procedural success was 97.8%.
Procedure- and device-related major adverse events occurred in 29 patients (5.8%) within 1 week of LAA closure. The researchers defined procedure- and device-related major adverse events as death, stroke, major/life-threatening bleeding, major access-site vascular complications, device embolization, serious pericardial effusion or need for CV surgery within 1 week after LAA closure.
Device repositioning (OR = 9.13; 95% CI, 2.85-33.54) and LVEF of less than 30% (OR = 4.08; 95% CI, 1.49-11.2) were identified as independent predictors of early major adverse events.
The researchers found no link between procedural success or major adverse events and angiographic LAA morphology. The most common types of angiographic morphology were cauliflower (33%) and cactus (32%).
In other results, the researchers did not identify a learning-curve effect related to the occurrence of major adverse events. “This is likely because LAA closure interventions have been performed at our institutions since 2002, whereas the present registry was initiated only in 2009. Along these lines, the present observations from two experienced centers may not be directly applicable to other sites with varying levels of operator and institutional expertise with the procedure and the specific devices,” Koskinas and colleagues wrote.
The data also show “comparable early outcomes” between the Amplatzer amulet and cardiac plug, but the researchers noted that “this finding should be interpreted cautiously in view of the observational nature of the study.” – by Katie Kalvaitis
Disclosure: Three researchers report financial ties with St. Jude Medical. Please see the full study for a list of the researchers’ relevant financial disclosures.
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