HELEX Septal Occluder for transcatheter closure of patent foramen ovale: multicentre experience.

AIMS: Patients with cryptogenic embolic events and a patent foramen ovale (PFO) are at risk of paradoxical embolism causing recurrent cerebral events; however, transcatheter PFO closure remains controversial. The aim of this multicentre trial was to demonstrate the feasibility and safety of transcatheter closure of PFO with the HELEX Septal Occluder. METHODS AND RESULTS: The study enrolled 128 patients (66 female; mean age, 50 years). Mean (+/-SD) PFO size was 10+/-3.7 mm; 38 patients also had an atrial septal aneurysm. Device implantation was successful in 127 patients. Device-related events during implantation or follow-up were device embolisation, wire-frame fracture, and retrieval cord breaks (two cases each; no sequelae). Other adverse events included atrial arrhythmia (two patients), migraine, convulsion, and transient ischaemic attack (one case each). There were no recurrent strokes, deaths, perforations, or accumulations of thrombi on the device. Within a mean follow-up period of 21+/-11 months, complete PFO closure using one device was achieved in 114 patients (90%). Five patients with a moderate to large residual shunt received a second device. CONCLUSION: The HELEX Occluder can be used for PFO closure. Device- and procedure-related complications are rare. The closure procedure appears to reduce recurrence rates of stroke and transient ischaemic attack.

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.

Transcatheter treatment of atrial septal aneurysm associated with patent foramen ovale for prevention of recurrent paradoxical embolism in high-risk patients.

OBJECTIVES: This study sought to investigate the safety and efficacy of transcatheter treatment of atrial septal aneurysm (ASA) associated with patent foramen ovale (PFO). BACKGROUND: Patients with both ASA and PFO are at high risk for recurrent paradoxical embolism. METHODS: The procedural, echocardiographic, and clinical outcomes of 141 patients with ASA + PFO and > or =1 paradoxical embolic event undergoing transcatheter treatment were compared with 220 patients with PFO alone. RESULTS: Device success (ASA + PFO, 99.3%; PFO alone, 99.5%; p = 0.75) and procedural complications (ASA + PFO, 0.7%; PFO alone, 3.2%; p = 0.12) were similar in both groups. Maximal atrial septal excursion in patients with ASA + PFO decreased from 16 +/- 4 mm before to 4 +/- 3 mm after the intervention (p < 0.0001). At 6 months follow-up, right-to-left shunt was abolished in 120 (86%) patients with ASA + PFO, compared to 187 (85%) patients with PFO alone (p = 0.80). Freedom from recurrent transient ischemic attack, stroke, and peripheral embolism at 4 years was 95% (ASA + PFO) and 94% (PFO alone, p = 0.70), respectively. A residual right-to-left shunt after the intervention was the only predictor for recurrence (hazard ratio [HR] 6.9; 95% confidence interval [CI] 1.3 to 36.9, p < 0.03) in patients with ASA + PFO. CONCLUSIONS: Transcatheter treatment of ASA + PFO is safe and effective in patients with paradoxical embolism. The procedure effectively abolishes right-to-left shunt and decreases atrial septal mobility. Long-term prevention of recurrent events appears favorable when compared to patients with PFO alone.

Incidence and clinical course of thrombus formation on atrial septal defect and patient foramen ovale closure devices in 1,000 consecutive patients.

OBJECTIVES: The purpose of this study was to investigate the incidence, morphology, and clinical course of thrombus formation after catheter closure of intra-atrial shunts. BACKGROUND: Post-procedure detailed information about thrombotic material on different devices for transcatheter closure is missing. METHOD: A total of 1,000 consecutive patients were investigated after patent foramen ovale (PFO) (n = 593) or atrial septal defect (ASD) (n = 407) closure. Transesophageal echocardiography (TEE) was scheduled after four weeks and six months. Additional TEEs were performed as clinically indicated. RESULTS: Thrombus formation in the left atrium (n = 11), right atrium (n = 6), or both (n = 3) was found in 5 of the 407 (1.2%) ASD patients and in 15 of the 593 (2.5%) PFO patients (p = NS). The thrombus was diagnosed in 14 of 20 patients after four weeks and in 6 of 20 patients later on. The incidence was: 7.1% in the CardioSEAL device (NMT Medical, Boston, Massachusetts); 5.7% in the StarFLEX device (NMT Medical); 6.6% in the PFO-Star device (Applied Biometrics Inc., Burnsville, Minnesota); 3.6% in the ASDOS device (Dr. Ing, Osypka Corp., Grenzach-Wyhlen, Germany); 0.8% in the Helex device (W.L. Gore and Associates, Flagstaff, Arizona); and 0% in the Amplatzer device (AGA Medical Corp., Golden Valley, Minnesota). The difference between the Amplatzer device on one hand and the CardioSEAL device, the StarFLEX device, and the PFO-Star device on the other hand was significant (p < 0.05). A pre-thrombotic disorder as a possible cause of the thrombus was found in two PFO patients. Post-procedure atrial fibrillation (n = 4) and persistent atrial septal aneurysm (n = 4) had been found as significant predictors for thrombus formation (p < 0.05). In 17 of the 20 patients, the thrombus resolved under anticoagulation therapy with heparin or warfarin. In three patients, the thrombus was removed surgically. CONCLUSIONS: The incidence of thrombus formation on closure devices is low. The thrombus usually resolves under anticoagulation therapy.

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.

An endovascular approach to cardioembolic stroke prevention in atrial fibrillation patients.

This report is of a 62-year-old woman presenting with a 3-year history of chronic atrial fibrillation (AF) and unable to tolerate chronic warfarin therapy due to bleeding episodes and unstable INR values. Additional high risk factors for stroke are a history of congestive heart failure and previous embolic stroke. Percutaneous left atrial appendage transcatheter occlusion (PLAATO ) was performed to seal the LAA. A transesophageal echocardiography (TEE) at the 1- and 6-month follow-up showed no device migration and no new thrombus related to the implant. The patient has been doing well on postprocedure aspirin with no embolic events.

Cardiac perforation following transcatheter PFO closure.

From December 1998 to August 2001, transcatheter closure of patent foramen ovale (PFO) with an Amplatzer PFO occluder has been successfully performed in our center in 102 patients without severe complications. We are reporting the first known case of cardiac perforation by an Amplatzer PFO occluder.