Y Bayard

PLAATO (Percutaneous Left Atrial Appendage Transcatheter Occlusion) for prevention of cardioembolic stroke in non-anticoagulation eligible atrial fibrillation patients: results from the European PLAATO study

The European PLAATO (Percutaneous Left Atrial Appendage Transcatheter Occlusion) study was performed to determine the safety and efficacy of left atrial appendage occlusion by catheter technique. Embolic stroke due to atrial fibrillation is a common observation, especially in the elderly. Most thrombi in atrial fibrillation form in the left atrial appendage (LAA), its occlusion may therefore reduce the incidence of stroke in these patients.

Comparison of three patent foramen ovale closure devices in a randomized trial (Amplatzer versus CardioSEAL-STARflex versus Helex occluder).

This randomized trial compared procedural complications and 30-day clinical outcomes of 3 patent foramen ovale (PFO) closure devices (Amplatzer, Helex, and CardioSEAL-STARflex). It examined 660 patients (361 men, 299 women, mean age 49.3+/-1.9 years), with 220 patients per group. All patients had a history of paradoxical embolism. All PFO closures were successful technically. Exchange of devices for others was most frequently required for the Helex occluder (7 of 220) and 2 of 220 in either of the other groups. Three device embolizations in the Helex group were retrieved and replaced successfully. One patient with a Helex occluder developed a transient ischemic attack and recovered without treatment. A hemopericardium in that group was punctured without affecting the device. One tamponade in the Amplatzer group required surgical device explantation. In 8 of 660 patients in the CardioSEAL-STARflex group, thrombi resolved after anticoagulation. Sixteen patients (11 in the CardioSEAL-STARflex group, 3 in the Amplatzer group, and 2 in the Helex group) had episodes of atrial fibrillation. PFOs were closed completely in 143 of 220 patients (65%) in the Amplatzer group, 116 of 220 patients (52.7%) in the Helex group, and 137 of 220 patients (62.3%) in the CardioSEAL-STARflex group at 30 days with significant differences between the Helex and Amplatzer occluders (p=0.0005) and the Helex and CardioSEAL-STARflex occluders (p=0.0003). PFO closure can be performed safely with each device. In conclusion, the Helex occluder embolized more frequently. Device thrombus formation and paroxysmal atrial fibrillation were more common with the CardioSEAL-STARflex occluder.

Transcatheter occlusion of the left atrial appendage for stroke prevention

Patients with atrial fibrillation are at an increased risk of having a cardioembolic stroke. Most of the thrombi responsible for these ischemic events originate in the left atrial appendage. Percutaneous occlusion of the left atrial appendange is a new approach to stroke prevention in patients with atrial fibrillation and contraindication for long-term warfarin treatment. Three different devices have been used so far: the PLAATO™ system, the WATCHMAN® filter system and the Amplatzer® septal occluder. Left atrial appendage occlusion using these devices is feasible and safe and has shown promising results. The risk of stroke in atrial fibrillation patients appears to be reduced.

Percutaneous Closure of the Left Atrial Appendage : A Major Step Forward⁎

Atrial fibrillation is a common cardiac arrhythmia with a higher prevalence in the elderly population. It is more frequent in men than in women at all ages ([1][1]). It might cause a reduced cardiac output and formation of atrial thrombi, especially in the left atrial appendage ([2][2]). Atrial

Alternatives to warfarin in atrial fibrillation: drugs and devices

Atrial fibrillation is a common cardiac arrhythmia with a higher prevalence in the elderly. It is more common in men than in women at all ages.1 It may cause a reduced cardiac output and formation of atrial thrombi, especially in the left atrial appendage.2 Atrial fibrillation is associated with a fivefold increased risk for stroke and embolism3 and accounts for as much as one-sixth of all ischaemic strokes.4 These strokes tend to be more severe than cerebral embolisms caused by other sources, probably owing to the larger size of thrombi in atrial fibrillation.5 6 In this editorial, we discuss different medical, surgical and catheter-based approaches to the prevention of stroke in patients with non-rheumatic atrial fibrillation. ### Warfarin Several randomised studies such as the AFFIRM and the RACE trial have demonstrated the benefit of anticoagulation treatment in patients with both rhythm- and rate-controlled atrial fibrillation. With a stroke risk reduction of almost 70%, warfarin is highly effective in preventing embolic events in patients with atrial fibrillation and is better than other pharmacological approaches.7 Compared with aspirin, oral anticoagulation reduces the risk of stroke by 45%. However, it may increase the risk of major bleeding by about 70% compared with aspirin, accounting for severe bleeding in up to 2.3% of patients a year.8 Other disadvantages of warfarin are its narrow therapeutic range, pharmacological and food interactions and the need for frequent monitoring and dose adjustments. These may be some of the reasons why only 54% of all high-risk patients who are eligible for oral anticoagulation therapy actually receive warfarin.9 A recent review of the FDA Surveillance and Epidemiology Office showed that warfarin was among the top 10 drugs with the largest number of serious adverse event reports between 1990 to 2000.10 Furthermore, US death …

All comers 5 french transfemoral percutaneous coronary intervention without sheath

Background: There is an interest to keep the arterial access site for percutaneous coronary interventions (PCI) small. Using sheaths for introduction of arterial catheters is standard. The effective outer diameter of the usual introducer sheaths is about 1.5 French (F) larger than the labeled size. Omitting the sheath affords a smaller access without loss of working lumen. Methods: PCI was performed with sheathless 5 F guiding catheters in 503 consecutive all comers via femoral access. Diagnostic assessment of the coronary arteries was performed at the beginning using 4 F diagnostic catheters with 4 F sheaths in 293 patients (58%). In the remaining patients, a sheathless 5 F Amplatz left 2 (AL2) guiding catheter was used for both diagnostic study and PCI. Data analysis was performed retrospectively using catheterization reports and hospital summaries. Results: PCI without sheath was successful in 500 of 503 patients (99%).Balloon coronary angioplasty only was performed in 155 (31%) patients, and stenting in 346 (69%). In six patients, a 6 F sheath and catheter were used additionally for various reasons. Femoral closure devices were used in 23 patients (5%). The femoral access complication rate was 5% with a major hematoma in 2%. In‐hospital mortality and Q‐wave myocardial infarction rate were both 0.2% (one patient each). A single AL2 guiding catheter with 17 exceptions and an average of 1.1 coronary guidewires per case were used. No direct complications regarding the 5 F access without a sheath were noted. Mean hospitalization time was 2.2 ± 1.5 (range 1–25) days. Conclusion: The 5 F PCI without sheath can be performed safely in all comers. Vascular access bleeding complication rates were comparable, if not lower than with the conventional 6 F interventions with or without closure devices. The savings in material are substantial.