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.

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.

Percutaneous devices for stroke prevention.

The most important approaches to prevent cerebral ischemia by catheter technique are patent foramen ovale (PFO) closure in patients with a history of cryptogenic stroke and left atrial appendage (LAA) occlusion in atrial fibrillation (AF) patients. Over the past years, several new devices have been developed for these procedures. Results of randomized trials comparing device therapy, antiplatelet, or anticoagulation therapy are still not available. However, several nonrandomized studies have shown promising results. This article gives a review on the current results and techniques of the most commonly used devices as well as on new developments and approaches to catheter-based stroke prevention.

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.

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.

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 appendage 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.

Patients with atrial fibrillation (AF) are at high risk of stroke. More than 15% of all strokes are due to atrial fibrillation. So far anticoagulation is the treatment of choice with a risk reduction of almost 70%. On the other hand, anticoagulation has many side effects such as intracranial or gastrointestinal hemorrhage. Closing the left atrial appendage (LAA) might be an alternative in patients who cannot take anticoagulation treatment due to contraindications or conditions in which the hazard of hemorrhage is greater than the potential clinical benefit. The PLAATO system (Percutaneous Left Atrial Appendage Transcatheter Occlusion) is a new device to close the LAA by the catheter technique. The device consists of a self-expandable nitinol cage that is covered with ePTFE. It is delivered via a specially designed 12F transseptal sheath. Small anchors along the struts prevent the occluder from embolizing. After device implantation patients are placed on aspirin only. The results of the dog model and the first clinical experiences in humans have been very promising.