Xavier Freixa

Percutaneous Left Atrial Appendage Closure With the AMPLATZER Cardiac Plug Device in Patients With Nonvalvular Atrial Fibrillation and Contraindications to Anticoagulation Therapy

OBJECTIVESnThe aim of this study was to evaluate the results associated with left atrial appendage closure (LAAC) with the AMPLATZER Cardiac Plug (ACP) (St. Jude Medical, Minneapolis, Minnesota) in patients with nonvalvular atrial fibrillation and absolute contraindications to anticoagulation therapy.nnnBACKGROUNDnFew data exist on the late outcomes after LAAC in patients with absolute contraindications to warfarin.nnnMETHODSnA total of 52 patients with nonvalvular atrial fibrillation underwent LAAC with the ACP device in 7 Canadian centers. Most patients received short-term (1 to 3 months) dual-antiplatelet therapy after the procedure and single-antiplatelet therapy thereafter. A transesophageal echocardiography was performed in 74% of patients at the 6-month follow-up. No patient was lost to follow-up (≥ 12 months in all patients).nnnRESULTSnThe mean age and median (interquartile range) CHADS2 score were 74 ± 8 years and 3 (2 to 4), respectively. The procedure was successful in 98.1% of the patients, and the main complications were device embolization (1.9%) and pericardial effusion (1.9%), with no cases of periprocedural stroke. At a mean follow-up of 20 ± 5 months, the rates of death, stroke, systemic embolism, pericardial effusion, and major bleeding were 5.8%, 1.9%, 0%, 1.9%, and 1.9%, respectively. The presence of mild peridevice leak was observed in 16.2% of patients at the 6-month follow-up as evaluated by transesophageal echocardiography. There were no cases of device thrombosis.nnnCONCLUSIONSnIn patients with nonvalvular atrial fibrillation at high risk of cardioembolic events and absolute contraindications to anticoagulation, LAAC using the ACP device followed by dual-/single-antiplatelet therapy was associated with a low rate of embolic and bleeding events after a mean follow-up of 20 months. No cases of severe residual leak or device thrombosis were observed at the 6-month follow-up.

Left atrial appendage closure with the Amplatzer™ Cardiac Plug: Impact of shape and device sizing on follow-up leaks ☆

BACKGROUNDnThe Amplatzer Cardiac Plug (ACP) is a relatively new system for left atrial appendage (LAA) closure. In general, the particular design of the device and the variability of the LAA anatomy make the sizing process challenging. The objective of our study was to analyze the impact of the shape and sizing of the device on the presence of follow-up leaks.nnnMETHODSnThe shape was evaluated by angiography and classified as strawberry-like, square-like and tire-like. The presence of peri-device leaks was assessed by transesophageal echocardiography (TEE) and graded as: 1) severe, 2) major, 3) moderate, 4) minor and 5) absent.nnnRESULTSnTwenty five patients were included. Overall, the device was oversized by 3.38 ± 2.26 mm and 1.58 ± 2.75 mm in relation to the largest angiographic and TEE diameter respectively. None of the patients presented any intra-procedural complication. After discharge, one patient was admitted for cardiac tamponade and another for stroke. In both, the device was optimally deployed. Follow-up TEE was done after a mean time of 7.9 ± 5.9 months. The presence of a leak was associated with a lower degree of device over-sizing by TEE (0.06 ± 3.31 mm if leak vs. 2.73 ± 1.85 mm if no leak; p=0.04) and a trend towards by angiography (2.39 ± 3.06 mm if leak vs. 3.98 ± 1.57 mm if no leak; p=0.16). The shape of the device was not associated with the presence of TEE leaks. Neither the shape nor the presence of leaks was associated with worse clinical outcomes.nnnCONCLUSIONSnAlthough the shape and sizing of the device were not linked to any particular clinical outcome, we found an association between a lower degree of over-sizing and the presence of follow-up leaks.

Percutaneous Closure of a Very Large Left Atrial Appendage Using the Amplatzer Amulet

Although percutaneous left atrial appendage (LAA) closure is becoming a common procedure worldwide, there are still some anatomic limitations. The size of the LAA is one of the current limitations as the most popular devices do not allow the closure of very large LAAs. The new Amplatzer Cardiac Plug 2, also called Amulet, has been redesigned not only to improve delivery and safety but also to allow the closure of larger LAAs. The present report describes the successful closure of a very large LAA using the Amulet.

First experience with the new GORE® septal occluder for the closure of multiple atrial septal defects

Transcatheter closure of an atrial septal defect (ASD) is considered the standard of care for most of the patients with secundum ASD. The existence of multiple or fenestrated ASD may constitute a challenge to achieve a satisfactory result. Data on the usage of multiple devices for closing multiple defects are limited. The GORE® Septal Occluder (GSO) represents a new generation of transcatheter ASD occluders with a design that provides superior conformability, apposition, and closure performance compared with the previous GORE® HELEX device. The present case report describes the first clinical experience with the implantation of two GSO devices in a patient with multiple ASDs and fenestrated septum.

Impact of coronary artery disease on left ventricular ejection fraction recovery following transcatheter aortic valve implantation.

The objective of the present study was to assess if the presence and severity of CAD is associated with decreased LVEF recovery after TAVI.

A Novel System for Transcatheter Closure of Patent Foramen Ovale: Clinical and Echocardiographic Outcome Comparison With Other Contemporary Devices

BACKGROUNDnEffective closure performance for patent foramen ovale (PFO) has been suggested to be one of the factors that plays a relevant role in future clinical outcomes after stroke or transient ischemic attack.nnnMETHODSnBetween January 2009 and June 2012, all consecutive patients undergoing transcatheter PFO closure in our institution using the Amplatzer PFO Occluder (APO) (St Jude Medical, St Paul, MN), BioSTAR (NMT Medical Inc, Boston, MA), GORE HELEX (HELEX) (W.L. Gore & Associates, Newark, DE), and GORE Septal Occluder (GSO) (W.L. Gore & Associates) were included. Closure performance was assessed usingxa0transesophageal echocardiography 4 months after the index procedure.nnnRESULTSnOne hundred ninety-three patients were included in the study. Patient distribution was as follows: (1) 48 GSO (24.8%); (2) 34 HELEX (17.6%); (3) 74 APO (38.3%); and (4) 37 BioSTAR (19.1%). No complications occurred during device implantation. During clinical follow-up (20.8 ± 13.2 months), 2 (1.1%) patients had a stroke, 3 (1.7%) patients had a peripheral embolism, and 8 (4.7%) patients presented with a documented atrial arrhythmia. There were no significant differences in clinical outcomes among the devices. Transesophageal echocardiography follow-up revealed higher closure rates with GSO (92.6%) and BioSTAR (93.7%) compared with HELEX (74.2%; Pxa0= 0.031 and Pxa0= 0.034, respectively) and APO (76.4%; Pxa0= 0.036 and Pxa0= 0.041, respectively).nnnCONCLUSIONSnThe GSO and BioSTAR showed better closure rates than HELEX and APO at 4 months. PFO closure is a safe procedure with a low rate of clinical events at follow-up.

Intra-procedural imaging of the left atrial appendage: implications for closure with the Amplatzer™ cardiac plug.

OBJECTIVESnTo evaluate intra-procedural imaging with transesophageal echocardiography and angiography during left atrial appendage occlusion using the Amplatzer™ Cardiac Plug with regard to sizing and final device shape.nnnMETHODSnLeft atrial appendage ostium dimensions and diameter at a depth of 10mm from the ostium were measured by transesophageal echocardiography (0-180°) and angiography (RAO 30° - Cranial 20°) in consecutive patients undergoing left atrial appendage occlusion using the ACP with an oversizing strategy of 10-20% relative to the baseline measurements. After delivery, ACP dimensions were measured and device shape was assessed.nnnRESULTSnTwenty-seven consecutive patients underwent successful uncomplicated left atrial appendage closure with Amplatzer™ Cardiac Plug. We found a significant difference between the largest and smallest left atrial appendage diameter measured with transesophageal echocardiography (22.3±4.2 vs. 18.1±4.1mm, p<0.001). By the end of the procedure (by angiography), ACP had an optimal shape in 17 patients (63%), a strawberry-like shape in 7 patients (26%), and a square-like shape in 3 patients (11%). ACP was oversized on average by 1.5±2.7 and 3.3±2.3mm compared to transesophageal echocardiography and angiography, respectively. The final shape of the device was not significantly associated with the degree of oversizing.nnnCONCLUSIONSnWe found a considerable variability in the assessment of the left atrial appendage, using transesophageal echocardiography and angiography. The degree of Amplatzer™ Cardiac Plug expansion within the left atrial appendage and the final shape of the device were not associated with the degree of oversizing.

Percutaneous transcatheter aortic valve implantation: present and future perspective.

Transcatheter aortic-valve implantation is becoming the standard of care for inoperable patients with severe aortic stenosis and a valid alternative for those at high surgical risk. Since the first percutaneous transcatheter aortic-valve implantation in humans in 2002, over 50,000 transcatheter aortic valves have been implanted in the last decade, with progressive improvement in the available devices. Overall, there are two main families of transcatheter prosthesis: self-expandable and nonself-expandable. The self-expandable devices, for which CoreValve® (Medtronic CV Luxembourg S.a.r.l., Luxembourg) represents the prototype, are characterized by a structure composed of shape memory materials, usually nitinol, which acquire its final shape once released. By contrast, the non-self-expandable prostheses, mainly represented by the Edwards® valve (Edwards Life Sciences, Inc., CA, USA), require balloon dilatation to reach its final shape. Although several publications have already provided positive data on both technologies, new clinical studies with improved systems are currently being conducted in order to provide more solid data and potentially expand the spectrum of patients who can benefit from this therapy. Thus, the aim of the present paper is to review the salient features of the two most used systems today (third-generation CoreValve and Edwards SAPIEN XT®) as well as to provide data on other emerging valves and future perspectives.

Internal thoracic artery dissection: a proposed mechanistic explanation.

A 61-year-old man with previous single bypass surgery of the left internal thoracic artery to the left anterior descending artery in 1996 presented to the emergency department with chest pain and anterior negative T waves. From time of surgery the patient remained asymptomatic until the day of

Unusual Coronary Occlusion Post Transcatheter Aortic Implantation: The Importance of Clinical Assessment

Despite the increasing experience with transcatheter aortic valve implantation, the incidence of severe complications is still relevant. One of the most feared complications is coronary obstruction. This life-threatening complication, occurring in up to 1% of patients, might be catastrophic, presenting with hemodynamic instability but allowing for rapid detection and treatment. To date, all published cases have reported ostial occlusions of either the left main or the right coronary artery. We describe an uncommon presentation of distal right coronary artery obstruction post transcatheter aortic valve implantation that was diagnosed after the patient developed chest pain in the recovery room.