Malattached septum primum and deficient septal rim predict unsuccessful transcatheter closure of atrial communications.

OBJECTIVES: Assess impact of malattached septum primum (MASP) on transcatheter closure of interatrial communications. BACKGROUND: Large defect size and deficient rims have been described as predictors for complications and unsuccessful device placement in closure of interatrial communications. MASP is an underappreciated morphologic atrial septal variation whose prevalence in isolated atrial communications and its influence on percutaneous device closure has not been systematically assessed. METHODS: We retrospectively evaluated echocardiographic data of 328 patients scheduled for percutaneous secundum atrial septal defect (ASD) and patent foramen ovale (PFO) closure between January 2006 and January 2013. In ASD patients, defect size was measured by balloon stretch diameter while the length of the surrounding rims was measured in standard transthoracic and transesophageal views. Furthermore, the distance between septum primum and septum secundum as it attaches to the left atrial roof was evaluated in both, ASD and PFO patients. Septal anatomy of patients with procedural failure was compared to the anatomy of patients in whom the procedure was successful. RESULTS: Transcatheter defect closure was successful in 131 (92.3%) of 142 ASD patients (32.3 years ± 24.7 years) and in all 186 PFO patients (49.6 years ± 16.2 years). Thirteen (4%) patients were found to have MASP (1.6 mm-13 mm). Smaller retroaortic rim, inferior rim, and the presence of a MASP were independently associated with procedural failure in ASD patients (P = 0.02, P = 0.03, and P = 0.003, respectively). CONCLUSION: Smaller retroaortic and inferior rims, as well as MASP are independent risk factors for unsuccessful transcatheter ASD closure.

Upgraded heart failure therapy leads to an improved outcome of dilated cardiomyopathy in infants and toddlers.

OBJECTIVE: Dilated cardiomyopathy is a leading cause of cardiac death in children. Approximately 30% of children die or need cardiac transplantation in the first year after establishing the diagnosis. New strategies are needed to improve the outcome in this high-risk patient population. METHOD AND RESULTS: We present our experience in 38 patients below the age of three years, who were diagnosed with dilated cardiomyopathy and who were treated at our institution between 2006 and 2012. The treatment strategy involved institution of ß-blockers and angiotensin-converting enzyme inhibitors as soon as feasible. In selected cases, pulmonary artery banding or intracoronary autologous bone marrow-derived cell therapy was performed. The median age at presentation was six months (range 1-26 months). The median follow-up age was 16 months (range 2-80 months). Kaplan-Meier analysis of survival after dilated cardiomyopathy diagnosis revealed a one-year survival of 97% and a five-year survival of 86%. The rate of freedom from death or heart transplantation was 82% at one year and 69% at five years. Surviving patients who were free of transplantation, at the follow-up at 25 months (3-80 months), showed a significant improvement in left ventricular ejection fraction (from 19±11 to 46±16%) and left ventricular end-diastolic diameter (z-score from 4.6±2.4 to 1.4±1.6). In addition, the levels of B-type natriuretic peptide improved significantly (from 3330±3840 to 171±825 pg/ml). CONCLUSION: Our data suggest that the clinical approach described here may result in a markedly improved medium-term outcome in young children with dilated cardiomyopathy. Further studies are required to evaluate whether these approaches reduce end-points such as transplantation or death.

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.

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.

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.

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 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.