Nicolas Majunke

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 left atrial appendage closure: Technical aspects and prevention of periprocedural complications with the watchman device

Transcatheter closure of the left atrial appendage has been developed as an alternative to chronic oral anticoagulation for stroke prevention in patients with atrial fibrillation, and as a primary therapy for patients with contraindications to chronic oral anticoagulation. The promise of this new intervention compared with warfarin has been supported by several, small studies and two pivotal randomized trial with the Watchman Device. The results regarding risk reduction for stroke have been favourable although acute complications were not infrequent. Procedural complications, which are mainly related to transseptal puncture and device implantation, include air embolism, pericardial effusions/tamponade and device embolization. Knowledge of nature, management and prevention of complications should minimize the risk of complications and allow transcatheter left atrial appendage closure to emerge as a therapeutic option for patients with atrial fibrillation at risk for cardioembolic stroke.

Left Atrial Appendage Closure in Patients With Contraindications to Oral Anticoagulation

The PROTECT AF (Watchman Left Atrial Appendage Closure Technology for Embolic Protection in Patients With Atrial Fibrillation) and PREVAIL (Prospective Randomized Evaluation of the Watchman LAA Closure Device In Patients With Atrial Fibrillation Versus Long-Term Warfarin Therapy) trials revealed

Percutaneous closure of patent foramen ovale with a novel FlatStent

Patent foramen ovale (PFO) is a congenital, small tunnel-like connection between the right and left atria that usually closes spontaneously after birth. However, frequently (in up to 35% of the normal population) it persists into adulthood. It is associated with ‘paradoxical’ embolism from the venous to the arterial system and may result in stroke or peripheral embolism. One prophylactic treatment option is transcatheter closure of the PFO. Currently available closure devices extend into both atria and therefore occasionally cause complications, such as thrombus formation or erosion of adjacent structures. The Coherex FlatStent™ is a flat, self-expanding stent that is designed to be positioned within the PFO tunnel. It is a very small, low-mass device that minimizes the amount of implanted foreign material to reduce the risk of device-related complications. This article focuses on the anatomy of PFOs and compares the Coherex FlatStent™ with currently available and experimental PFO closure devices.

A suture not always the ideal solution: Problems encountered in developing a suture-based PFO closure technique†

Objectives: To summarize our experiences with the first‐in‐man suture‐based patent foramen ovale (PFO) closure technique. Background: PFO is often present with the occurrence of cryptogenic stroke and migraine with aura. Successful PFO closure can be performed percutaneously using catheter techniques with many different closure devices. The described novel closure system is intended to deliver, via endovascular access, a suture into the atrial septal wall tissue for closure of PFO. Methods: Eleven patients, between 22 and 58 years of age (mean 46.6 ± 9.6), who had a cryptogenic ischemic stroke, TIA, or a peripheral embolism and a PFO were considered for percutaneous closure with this technique. Results: The mean stretched diameter of the defect evaluated during balloon sizing was 8.8 ± 0.4 mm (range 7–12.5). Delivery of the suture was successful in all patients. No intraprocedural complications occurred. During the follow up, complete closure could be achieved in one patient. Six patients with significant residual shunting during follow‐up had successful closure using a conventional device. One patient was lost for follow‐up after the 3‐month visit. The residual shunt in the remaining three patients was very small and they declined to be treated with a conventional device. No complications occurred during the follow up. Conclusions: Transcatheter application of a suture for closure of PFO is technically feasible and safe. However, despite successful suturing of the septum primum to the septum secundum, the PFO did not close in most of the patients.

Device closure of residual shunt after percutaneous closure of patent foramen ovale

AIMS To summarise our experiences of device closure of residual shunt after transcatheter closure of patent foramen ovale (PFO). METHODS AND RESULTS Since October 1997 implantation of a second closure device was attempted in 40 patients with a moderate or large residual shunt after implantation of a PFO closure device. The mean age of the patients was 51 years. Implantation of a second closure device was technically successful in 39/40 patients (98 %). The following devices were implanted: Premere (n=20), Amplatzer PFO (n=13), STARFlex (n=4), Helex (n=1), Angelwings (n=1). During a mean follow-up of 36+/-29 months complete closure was achieved in 27 patients (69 %). The remaining shunt was small in nine patients, moderate in one and large in two. One patient with a moderate and one patient with a large residual shunt received a third device. The third patient was sent to surgery. One patient died 21 days after implantation of a third closure device due to acute pericardial tamponade. No other complications occurred. CONCLUSIONS Transcatheter implantation of a second closure device after PFO closure is feasible. Complete closure can be achieved in the majority of patients.

Transcatheter closure of multiple interatrial communications

We sought to examine acute and midterm results of closure of multiple interatrial communications with staged device deployment and to review the relevant literature.

Recurrent events after percutaneous closure of patent foramen ovale

To determine the incidence of symptomatic recurrent embolic events after patent foramen ovale (PFO) closure and potential causes for these events.

How should I treat a misplaced self-expanding aortic bioprosthetic valve?

BACKGROUND A 70-year-old man diagnosed with hypertension, severe chronic obstructive lung disease and critical aortic stenosis symptomatic by NYHA functional class III heart failure and frequent hospitalisations for volume overload was referred for percutaneous aortic valve implantation. INVESTIGATION Cardiac catheterisation revealed a severe aortic stenosis with a peak to peak gradient of 95 mmHg and a mean gradient of 73 mmHg. Transesophageal echocardiography demonstrated an aortic valve area of 0.7 cm². DIAGNOSIS Severe symptomatic aortic stenosis by echocardiography and cardiac catheterisation. TREATMENT Transcatheter aortic valve replacement with an 29 mm CoreValve prosthesis.

Frequency and clinical course of cerebral embolism in patients undergoing transcatheter left atrial appendage closure.

AIMS The aim of this study was to assess silent and clinically apparent cerebral embolic events in patients undergoing transcatheter left atrial appendage closure. METHODS AND RESULTS In this prospective single-centre study, 28 patients underwent percutaneous closure of the left atrial appendage. In all patients, a diffusion-weighted magnetic resonance imaging (DW-MRI) study was performed before, the day after the procedure, and during routine follow-up after 45 days. All patients underwent neurological assessment at the time of DW-MRI. Additionally, transcranial Doppler ultrasound monitoring (TCD) for the detection of microembolic material during the procedure was performed. The procedure was successfully completed in all patients. New embolic lesions were detected in nine patients (32%) after the procedure, of which three (33%) were detectable as gliotic lesions at follow-up. One (3.6%) new lesion was observed at 45-day follow-up. Neurological assessment showed no neurological deficits. We observed no relationship between the numbers of microembolic signals on TCD monitoring and the occurrence of cerebral infarctions on DW-MRI. CONCLUSIONS New cerebral embolic events occur after transcatheter closure of the left atrial appendage. However, most of the lesions demonstrate no gliotic transformation at follow-up. In all patients, the cerebral lesions were clinically unapparent.