Outcomes of 10,312 patients treated with everolimus-eluting bioresorbable scaffolds during daily clinical practice - results from the European Absorb Consortium.

OBJECTIVES: To asses mid-term clinical outcomes of bioresorbable vascular scaffolds (BVS) for the treatment of coronary artery disease in a large-scale all-comers population. BACKGROUND: Several clinical settings are underrepresented in randomized studies investigating BVS against drug-eluting stents. Whether their results can be translated into the heterogeny patient population seen during daily routine requires further investigation. METHODS: The European ABSORB Consortium comprises the following European registries: GABI-R, ABSORB UK Registry, ABSORB France, BVS RAI Registry, and REPARA BVS Registry, which all prospectively collected patient-level data regarding outcomes following unrestricted BVS implantation. The primary endpoint of target lesion failure (TLF) includes cardiac death, target-vessel myocardial infarction (TVMI) and target-lesion revascularisation (TLR) at 12 months. The incidence of scaffold thrombosis (ST) according to ARC criteria was also assessed. Multivariable analysis was used to adjust for differences in patient and lesion characteristics. RESULTS: A total of 10,312 patients (mean age 58.4 ± 11.4 y) underwent BVS implantation during routine practice. The 12-month follow-up was complete in 95.5% of patients. At 12 months, the primary endpoint of TLF occurred in 3.6%; its components cardiac death, TVMI and TLR were documented in 1.2%, 1.8%, and 2.6%, respectively. The definite/probable ST rate was 1.7%. Absence of predilatation, discontinuation of DAPT and scaffold diameter below 3 mm were independent predictors of ST. CONCLUSIONS: The EAC demonstrates reasonable real-world clinical outcome data after BVS implantation. However, the rate of scaffold thrombosis remains high.

Transjugular closure of a residual septal device defect: a case report.

Background: Severe residual shunts after percutaneous closure of atrial septal defects are unusual. These patients are usually considered candidates for surgery. Case summary: We describe the transjugular closure of a residual atrial septal defect with significant left-to-right shunt due to a malpositioned large atrial septal device in a symptomatic 74-year-old female. Transjugular access was chosen first due to the unfavourable position of the device for delivery of a new one from the femoral approach. An overlapping Figulla® Flex II 27/30 mm PFO device was successfully implanted with the guidance of 3D-transoesophageal echocardiography. Discussion: This case demonstrates the safety and feasibility of transjugular access as an alternative to femoral or transhepatic approaches in patients with difficult atrial septal anatomies, who are usually referred for surgery.

Two-year clinical outcome from the Iberian registry patients after left atrial appendage closure.

AIMS: The aim of this study was to observe the percentage of thromboembolic and haemorrhagic events over a 2-year follow-up in patients with non-valvular atrial fibrillation (NVAF) undergoing closure of the left atrial appendage (LAA) with an occlusion device. Observed events and CHADS2 (congestive heart failure, hypertension, age, diabetes, stroke history), CHA2DS2-VASc (also adding: vascular disease and sex) and HAS-BLED (hypertension, abnormal liver/renal function, stroke history, bleeding predisposition, labile international normalised ratios, elderly, drugs/alcohol use)-predicted events were compared. METHODS: LAA closure with an occlusion device was performed in 167 NVAF patients contraindicated for oral anticoagulants and recruited from 12 hospitals between 2009 and 2013. At least two transoesophageal echocardiograms were performed in the first 6 months postimplantation. Antithrombotics included clopidogrel and aspirin. Patients were monitored for death, stroke, major and relevant bleeding and hospitalisation for concomitant conditions. Mean age was 74.68±8.58, median follow-up was 24 months, 5.38% had intraoperative complications and implantation was successful in 94.6% of subjects. Mortality during follow-up was 10.8%, mostly (9.5%) non-cardiac related. Bleeding occurred in 10.1% of subjects, 5.7% major and 4.4% minor though relevant, and 4.4% suffered stroke. Major bleeding and stroke/transient ischaemic attack events within 2 years (annual event rates, 290 patients/year) were less frequent than expected from CHADS2 (2.4% vs 9.6%), CHA2DS2-VASc (2.4% vs 8.3%) and HAS-BLED (3.1% vs 6.6%) risk scores (p<0.001, p=0.003, p=0.047, respectively). CONCLUSIONS: LAA closure with an occlusion device in patients contraindicated for oral anticoagulants is a therapeutic option associated with fewer thromboembolic and haemorrhagic events than expected from risk scores, particularly in the second year postimplantation.