Vivek Y Reddy1, Douglas N Gibson2, Saibal Kar3, William O'Neill4, Shephal K Doshi5, Rodney P Horton6, Maurice Buchbinder7, Nicole T Gordon8, David R Holmes9. 1. Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address: vivek.reddy@mountsinai.org. 2. Scripps Clinic, La Jolla, California. 3. Cedars Sinai Medical Center, Los Angeles, California. 4. Center for Structural Heart Disease, Henry Ford Hospital, Detroit, Michigan. 5. St. John's Health Center, Santa Monica, California. 6. Texas Cardiac Arrhythmia Institute, Austin, Texas. 7. Foundation for Cardiovascular Medicine, La Jolla, California. 8. Boston Scientific Corporation, St. Paul, Minnesota. 9. Department of Cardiology, Mayo Clinic, Rochester, Minnesota.
Abstract
BACKGROUND: Left atrial appendage closure (LAAC) was approved by the U.S. Food and Drug Administration (FDA) as a stroke prevention alternative to warfarin for patients with nonvalvular atrial fibrillation. However, clinical decision-making is confounded by the fact that although LAAC attenuates the anticoagulant-related lifetime risk of bleeding, implantation is associated with upfront complications. Thus, enthusiasm for LAAC as a treatment option has been appropriately tempered, particularly as the therapy is introduced beyond the clinical trial sites into general clinical practice. OBJECTIVES: This study evaluated the acute procedural performance and complication rates for all cases performed in the United States since FDA approval. METHODS: In the absence of a formal national clinical registry since regulatory approval in March 2015, we obtained procedural data on implantation procedures. Every LAAC procedure requires the presence of a manufacturer clinical specialist and for procedural parameter and periprocedural complication data to be collected using a standardized process and forms. RESULTS: In 3,822 consecutive cases, implantation was successful in 3,653 (95.6%), with a median procedure time of 50 min (range 10 to 210 min). Implanting physicians performing these procedures (n = 382) included 71% new, nonclinical trial implanters, who performed 50% of the procedures. Procedural complication rates included 39 pericardial tamponades (1.02%) (24 treated percutaneously, 12 surgically, and 3 fatal); 3 procedure-related strokes (0.078%); 9 device embolizations (0.24%) (6 requiring surgical removal); and 3 procedure-related deaths (0.078%). CONCLUSIONS: Despite a large fraction of previously inexperienced operators, in the real-world post-FDA approval experience of LAAC, procedural success was high and complication rates were low.
BACKGROUND:Left atrial appendage closure (LAAC) was approved by the U.S. Food and Drug Administration (FDA) as a stroke prevention alternative to warfarin for patients with nonvalvular atrial fibrillation. However, clinical decision-making is confounded by the fact that although LAAC attenuates the anticoagulant-related lifetime risk of bleeding, implantation is associated with upfront complications. Thus, enthusiasm for LAAC as a treatment option has been appropriately tempered, particularly as the therapy is introduced beyond the clinical trial sites into general clinical practice. OBJECTIVES: This study evaluated the acute procedural performance and complication rates for all cases performed in the United States since FDA approval. METHODS: In the absence of a formal national clinical registry since regulatory approval in March 2015, we obtained procedural data on implantation procedures. Every LAAC procedure requires the presence of a manufacturer clinical specialist and for procedural parameter and periprocedural complication data to be collected using a standardized process and forms. RESULTS: In 3,822 consecutive cases, implantation was successful in 3,653 (95.6%), with a median procedure time of 50 min (range 10 to 210 min). Implanting physicians performing these procedures (n = 382) included 71% new, nonclinical trial implanters, who performed 50% of the procedures. Procedural complication rates included 39 pericardial tamponades (1.02%) (24 treated percutaneously, 12 surgically, and 3 fatal); 3 procedure-related strokes (0.078%); 9 device embolizations (0.24%) (6 requiring surgical removal); and 3 procedure-related deaths (0.078%). CONCLUSIONS: Despite a large fraction of previously inexperienced operators, in the real-world post-FDA approval experience of LAAC, procedural success was high and complication rates were low.