Percutaneous left atrial appendage occlusion for patients in atrial fibrillation suboptimal for warfarin therapy: 5-year results of the PLAATO (Percutaneous Left Atrial Appendage Transcatheter Occlusion) Study.

OBJECTIVES: The aim of this study was to determine 5-year clinical status for patients treated with percutaneous left atrial appendage transcatheter occlusion with the PLAATO (Percutaneous Left Atrial Appendage Transcatheter Occlusion) system. BACKGROUND: Anticoagulation reduces thromboembolism among patients with nonvalvular atrial fibrillation (AF). However, warfarin is a challenging medication due to risks of inadequate anticoagulation and bleeding. Thus, PLAATO was evaluated as a treatment strategy for nonwarfarin candidate patients with AF at high risk for stroke. METHODS: Sixty-four patients with permanent or paroxysmal AF participated in this observational, multicenter prospective study. Primary end points were: new major or minor stroke, cardiac or neurological death, myocardial infarction, or requirement for cardiovascular surgery related to the procedure within 1 month of the index procedure. Patients were followed for up to 5 years. RESULTS: Thirty-day freedom from major adverse events rate was 98.4% (95% confidence interval: 90.89% to >99.99%). One patient, who did not receive a PLAATO implant, experienced 2 events within 30 days (cardiovascular surgery, death). Treatment success was 100% 1 month after device implantation. At 5-year follow-up, there were 7 deaths, 5 major strokes, 3 minor strokes, 1 cardiac tamponade requiring surgery, 1 probable cerebral hemorrhage/death, and 1 myocardial infarction. Only 1 event (cardiac tamponade) was adjudicated as related to the implant procedure. After up to 5 years of follow-up, the annualized stroke/transient ischemic attack (TIA) rate was 3.8%. The anticipated stroke/TIA rate (with the CHADS(2) scoring method) was 6.6%/year. CONCLUSIONS: The PLAATO system is safe and effective. At 5-year follow-up the annualized stroke/TIA rate in our patients was 3.8%/year, less than predicted by the CHADS(2) scoring system.

Percutaneous left atrial appendage transcatheter occlusion (PLAATO system) to prevent stroke in high-risk patients with non-rheumatic atrial fibrillation: results from the international multi-center feasibility trials.

OBJECTIVES: These studies were conducted to evaluate the feasibility of percutaneous left atrial appendage (LAA) occlusion using the PLAATO system (ev3 Inc., Plymouth, Minnesota). BACKGROUND: Patients with atrial fibrillation (AF) have a five-fold increased risk for stroke. Other studies have shown that more than 90% of atrial thrombi in patients with non-rheumatic AF originate in the LAA. Transvenous closure of the LAA is a new approach in preventing embolism in these patients. METHODS: Within two prospective, multi-center trials, LAA occlusion was attempted in 111 patients (age 71 +/- 9 years). All patients had a contraindication for anticoagulation therapy and at least one additional risk factor for stroke. The primary end point was incidence of major adverse events (MAEs), a composite of stroke, cardiac or neurological death, myocardial infarction, and requirement for procedure-related cardiovascular surgery within the first month. RESULTS: Implantation was successful in 108 of 111 patients (97.3%, 95% confidence interval [CI] 92.3% to 99.4%) who underwent 113 procedures. One patient (0.9%, 95% CI 0.02% to 4.9%) experienced two MAEs within the first 30 days: need for cardiovascular surgery and in-hospital neurological death. Three other patients underwent in-hospital pericardiocentesis due to a hemopericardium. Average follow-up was 9.8 months. Two patients experienced stroke. No migration or mobile thrombus was noted on transesophageal echocardiogram at one and six months after device implantation. CONCLUSIONS: Closing the LAA using the PLAATO system is feasible and can be performed at acceptable risk. It may become an alternative in patients with AF and a contraindication for lifelong anticoagulation treatment.

Complementary roles of color-flow duplex imaging and intravascular ultrasound in the diagnosis of renal artery fibromuscular dysplasia: should renal arteriography serve as the "gold standard"?

OBJECTIVES: The purpose of this study was to compare color-flow duplex imaging (CFDI), intravascular ultrasound (IVUS), and renal arteriography in diagnosing renal artery (RA) fibromuscular dysplasia (FMD) and correlating with the hemodynamic response to balloon angioplasty (BA) in patients with drug-resistant hypertension. BACKGROUND: Renal arteriography is generally regarded as the gold standard for diagnosing RA FMD. The observation that CFDI and IVUS depicted endoluminal abnormalities suggestive of RA FMD in some patients with normal renal arteriograms prompted comparison of these modalities in a consecutive series of patients. METHODS: Twenty hypertensive patients with CFDI suggestive of RA FMD (mid-to-distal flow derangement and velocity augmentation) underwent renal arteriography, IVUS, and BA, with both immediate and long-term blood pressure (BP) response assessment. RESULTS: All patients were women, aged 31 to 86 years (mean 62 years). On IVUS, various endoluminal defects (eccentric ridges; fluttering membranes; spiraling folds) were depicted at locations predicted by CFDI and were uniformly identified at sites where arteriography depicted classic evidence of FMD (8 patients). However, similar defects were detected by IVUS when angiography was borderline (7 patients) or normal (5 patients). Balloon angioplasty eliminated (16 patients) or reduced (4 patients) the IVUS findings and lowered systolic BP in all (mean reduction 53 mm Hg, p < 0.0001). This reduction was maintained during follow-up of 4 to 22 (mean 13) months (mean reduction 44 mm Hg, p < 0.0001), independent of baseline angiographic appearance. CONCLUSIONS: Both CFDI and IVUS depict the blood flow and endoluminal abnormalities of RA FMD. Balloon angioplasty eliminates or improves IVUS findings and produces substantial, sustained BP reduction, an effect that is independent of baseline arteriographic appearance, calling into question the legitimacy of arteriography as the diagnostic gold standard.