Heterogeneity of Treatment Effects in an Analysis of Pooled Individual Patient Data From Randomized Trials of Device Closure of Patent Foramen Ovale After Stroke.

Importance: Patent foramen ovale (PFO)-associated strokes comprise approximately 10% of ischemic strokes in adults aged 18 to 60 years. While device closure decreases stroke recurrence risk overall, the best treatment for any individual is often unclear.

Objective: To evaluate heterogeneity of treatment effect of PFO closure on stroke recurrence based on previously developed scoring systems.

International experience with the use of Cocoon septal occluder for closure of atrial septal defects.

Background: The Cocoon septal occluder (CSO) is a new generation double disk occluder device for catheter closure of the secundum atrial septal defect (ASD). Initial clinical evaluations with the use of this device have shown quite satisfactory results but large follow-up studies are missing. In this international multicenter study, we present procedural and follow-up data from 4008 patients with secundum ASD who underwent catheter closure with the use of CSO.

The effect of transcatheter aortic valve implantation approaches on mortality.

Objectives: We aimed to evaluate the effect of transcatheter aortic valve implantation (TAVI) approaches on mortality and identify effect modifiers and predictors for mortality.

Background: Alternative access routes to transfemoral (TF) TAVI include the surgical intra-thoracic direct-aortic (DA) and transapical (TA) approach. TA TAVI has been associated with a higher mortality rate.

Clinical Outcomes of the Portico Transcatheter Aortic Valve Delivered via Alternative Access: 30-Day and 1-Year Results of the Portico ALT Study.

Objective: The aim of this study was to report the 30-day and 1-year outcomes and performance from the Portico Alternative Access study to obtain CE approval of the alternative access delivery system.

Methods: The Portico Alternative Access study is a multicenter, prospective, non-randomized, investigational study (www.clinicaltrials.

Transcatheter Aortic Valve Replacement Outcomes in Patients With Native vs Transplanted Kidneys: Data From an International Multicenter Registry.

Background: Chronic kidney disease (CKD) has a negative impact on outcomes after transcatheter aortic valve replacement (TAVR). Data on outcomes in renal transplant recipients (RTRs) undergoing TAVR are scarce. We compared the outcomes in RTRs undergoing TAVR with matched patients who have native kidneys and similar kidney function.

Catheter closure of atrial septal defects using the Cocoon septal occluder: preliminary results of a European multicenter study.

Despite its simplicity, device closure of atrial septal defects is still associated with rare but potentially lethal complications. In this prospective non-randomized multicenter study we investigated the safety and efficacy of the Cocoon septal occluder (CSO) for closure of atrial septal defects (ASDs) in 92 patients. Median age of the patients was 10.

Early clinical outcome of aortic transcatheter valve-in-valve implantation in the Nordic countries.

Objective: Transcatheter valve-in-valve implantation has emerged as an option, in addition to reoperative surgical aortic valve replacement, to treat failed biologic heart valve substitutes. However, the clinical experience with this approach is still limited. We report the comprehensive experience of transcatheter valve-in-valve implantation in the Nordic countries from May 2008 to January 2012.