Bleeding and thrombotic risk of different antiplatelet regimens posttranscatheter edge-to-edge mitral valve repair in patients with an indication for oral anticoagulation: Results from an all-comers national registry.

BACKGROUND: Evidence-based recommendations for antithrombotic treatment in patients who have an indication for oral anticoagulation (OAC) after transcatheter edge-to-edge mitral valve repair (TEER) are lacking. AIMS: To compare bleeding and thrombotic risk for different antithrombotic regimens post-TEER with MitraClip in an unselected population with the need for OACs. METHODS: Bleeding and thrombotic complications (stroke and myocardial infarction) up to 3 months after TEER with mitraclip were evaluated in 322 consecutive pts with an indication for OACs. These endpoints were defined by the Mitral Valve Academic Research Consortium criteria and were compared between two antithrombotic regimens: single antithrombotic therapy with OAC (single ATT) and double/triple ATT with a combination of OAC and aspirin and/or clopidogrel (combined ATT). RESULTS: Collectively, 108 (34%) patients received single ATT, 203 (63%) received double ATT and 11 (3%) received triple ATT. Bleeding events occurred in 67 patients (20.9%), with access site related events being the most frequent cause (37%). Bleeding complications were observed more frequently in the combined ATT group than in the single ATT group: 24% versus 14% [p = 0.03, adjusted RR: 0.55 (0.3-0.98)]. Within the combined group, the bleeding risk was 23% in the double ATT and 45% in the triple ATT group. Thrombotic complications occurred in only three patients (0.9%), and all belonged to the combined ATT group. CONCLUSIONS: In patients with an indication for OACs, withholding of antiplatelet therapy post-TEER with Mitraclip was associated with a 45% reduction in bleeding and without a signal of increased thrombotic risk.

Dual antiplatelet therapy after percutaneous left atrial appendage occlusion: single center experience with the Amplatzer Cardiac Plug.

BACKGROUND: Percutaneous left atrial appendage occlusion (LAAO) is an alternative to anticoagulation in atrial fibrillation patients at high bleeding risk. Dual antiplatelet therapy (DAPT) is generally recommended in the months following the procedure to prevent thrombotic complications. The aim of this study was to evaluate the safety and efficacy of DAPT after LAAO in a single-centre population of high bleeding risk patients. METHODS: All patients who received DAPT after LAAO using the Amplatzer Cardiac Plug at Jessa Hospital (Hasselt, BE) between February 2011 and October 2016 were included. Patient characteristics, procedural outcome and clinical events (bleeding, stroke and adverse events) were prospectively followed. Changes in antithrombotic and/or anticoagulant regimens were assessed. RESULTS: Thirty-nine patients (77 ± 7 years, 51% male, CHA2DS2-VASc 5(3-6), Hypertension, Abnormal Renal/Liver Function, Stroke, Bleeding History or Predisposition, Labile INR, Elderly, Drugs/Alcohol Concomitantly (HAS-BLED) 3(3-4)) were included. An initial strategy of one month DAPT (n = 2) was changed to six months DAPT (n = 37) after one thrombotic complication (device thrombosis) at 4.5 months. Post-procedural DAPT duration was 6.1 ± 3.7 months, after which aspirin monotherapy (62%), no antiplatelet/anticoagulant therapy (15%) or a tailored antithrombotic regimen was maintained. At mean follow-up of 21 ± 13 months, seven patients had died (18%), no strokes had occurred (0%) and nine bleedings of which four were major (10%). All major bleedings occurred within the first six months after the procedure during DAPT. CONCLUSION: Antithrombotic therapy after percutaneous LAAO is needed to prevent thrombotic complications, yet these impose bleeding complications in this high-risk population. Further efforts are needed to define the optimal duration of DAPT, aimed at reducing bleeding complications while maintaining a low thrombosis rate.

Percutaneous closure of inter-atrial communications (atrial septal defect and patent foramen ovale): single-centre experience and mid-term follow-up.

BACKGROUND: Percutaneous closure of atrial septal defect (ASD) and patent foramen ovale (PFO) are increasingly being performed. Effective closure rate depends on the anatomy of the interatrial septum and the device used, but its relationship with outcome is poorly described. This study aimed at evaluating: (1) effective ASD and PFO closure rate, (2) factors related with effective closure rate, and (3) factors related with mid-term outcome. METHODS: All patients who underwent percutaneous ASD or PFO closure at Jessa Hospital Hasselt between April 2002 and February 2014 were enrolled. Closure rate was evaluated using consecutive contrast echocardiography studies. Adverse events were defined as a composite of all-cause mortality, hospitalization for heart failure, atrial arrhythmias and thrombo-embolic event. RESULTS: One-hundred and two patients (52 +/- 12 y, 42% male, 75 PFO and 27 ASD) were included in the study. Moderate residual shunt was present in 6% and 10% 6 years after ASD and PFO closure, respectively. The presence of an aneurysmatic interatrial septum was associated with residual shunt after PFO closure (HR 0.57 95% CI 0.33-0.96; P=0.031). Pulmonary hypertension (HR 1.09 95% CI 1.01-1.17; P=0.017) and a history of atrial arrhythmias in ASD (HR 4.28 95% CI 1.06-17.40; P=0.046) and age at closure (HR 1.09 95% CI 1.02-1.16; P=0.012) in PFO patients were related with adverse events. The highest rate of adverse events was observed after placement of a Helex Septal Occluder. Amplatzer and Occlutech devices yielded higher effective closure rates. CONCLUSIONS: Effective closure rates were acceptable 6 years after ASD and PFO closure. The presence of an aneurysmatic septum is associated with residual shunting after PFO closure. Pulmonary hypertension in ASD and older age at closure in PFO are associated with adverse outcome. Adverse events are more frequent with the Helex occluder and effective closure rate depends on the device used.