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.

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.

AIMS: 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. METHODS AND RESULTS: One hundred and eighty patients with non-rheumatic atrial fibrillation and contraindication to warfarin therapy were enrolled in the PLAATO study. Patients were eligible if they had a?history of transient ischaemic attack (TIA) or stroke or at least two independent risk factors for stroke such as age > or =75 years, hypertension, congestive heart failure or diabetes. The primary endpoint was LAA closure as determined by transesophageal echocardiography (TEE) two months after the procedure and stroke rate at 150 patient years. Left atrial appendage occlusion was successful in 162/180 patients (90%, 95% CI 83.1% to 92.9%). Two patients died within 24 hours of the procedure (1.1%, 95% CI 0.3% to 4%). Six cardiac tamponades were observed (3.3%, 95% CI 1.5% to 7.1%). In two cases, surgical drainage of the tamponade was necessary (1.1%, 95% CI 0.3% to 4%). In one patient, the device that was chosen was too small and embolised into the aorta after its release (0.6%, 95% CI 0.1% to 3.1%). It was snared and replaced without further complications. Successful occlusion of the LAA was achieved in 126/ 140 (90%, 95% CI 83.5% to 94.2%) of patients as noted by TEE at the two months follow-up. In a follow-up time of 129 documented patient years, three strokes occurred (2.3% per year). The expected incidence of stroke according to the CHADS2-Score was 6.6% per year. The trial was halted prematurely during the follow-up phase for financial considerations. CONCLUSIONS: Left atrial appendage closure is relatively safe and effective. However, severe complications can occur. It might become an alternative for atrial fibrillation patients who are ineligible for long-term anticoagulation therapy.