clinicaltrials.gov Identifier: NCT00645918.

Stent fracture may represent a new potential mechanism of restenosis and stent thrombosis in drug-eluting stents. Predisposing clinical and procedural factors may be vessel tortuosity and use of overlapping stents. The most important predisposing factor, however, may be stent structure, since all fractures occurred in sirolimus-eluting stents.

Despite a higher percentage of high-risk patients, PCI with DES for ULMCA disease was not associated with an increase in immediate or medium-term complications compared with CABG. Our data suggest that a randomized comparison between the two revascularization strategies for ULMCA may be warranted.

BACKGROUND Transcatheter left atrial appendage (LAA) ligation may represent an alternative to oral anticoagulation for stroke prevention in atrial fibrillation.. OBJECTIVES This study sought to assess the early safety and efficacy of transcatheter ligation of the LAA for stroke prevention in atrial fibrillation.. METHODS This was a retrospective, multicenter study of consecutive patients undergoing LAA ligation with the Lariat device at 8 U.S. sites. The primary endpoint was procedural success, defined as device success (suture deployment and <5 mm leak by post-procedure transesophageal echocardiography), and no major complication at discharge (death, myocardial infarction, stroke, Bleeding Academic Research Consortium bleeding type 3 or greater, or cardiac surgery). Post-discharge management was per operator discretion. RESULTS A total of 154 patients were enrolled. Median CHADS2 score (congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, prior stroke, transient ischemic attack, or thromboembolism [doubled]) was 3 (interquartile range: 2 to 4). Device success was 94%, and procedural success was 86%. A major complication occurred in 15 patients (9.7%). There were 14 major bleeds (9.1%), driven by the need for transfusion (4.5%). Significant pericardial effusion occurred in 16 patients (10.4%). Follow-up was available in 134 patients at a median of 112 days (interquartile range: 50 to 270 days): Death, myocardial infarction, or stroke occurred in 4 patients (2.9%). Among 63 patients with acute closure and transesophageal echocardiography follow-up, there were 3 thrombi (4.8%) and 13 (20%) with residual leak. CONCLUSIONS In this initial multicenter experience of LAA ligation with the Lariat device, the rate of acute closure was high, but procedural success was limited by bleeding. A prospective randomized trial is required to adequately define clinical efficacy, optimal post-procedure medical therapy, and the effect of operator experience on procedural safety.