Left atrial appendage closure with the Ultraseal device: Initial experience and mid-term follow-up.

AIMS: Left atrial appendage (LAA) closure is considered an effective option in patients with non-valvular atrial fibrillation (NVAF) and contraindications to long-term oral anticoagulant (OAC) therapy. However, there are some concerns about safety of currently available devices. Our aim is to provide an initial assessment on feasibility and safety of the novel LAA closure Ultraseal device in patients with NVAF and contraindications to long-term OAC therapy. METHODS: Twenty-three consecutive patients with NVAF undergoing Ultraseal device implantation between July 2016 and February 2018 at two institutions were included. All patients performed transesophageal echocardiography and computed tomography angiography prior to LAA closure. RESULTS: Procedural success was achieved in all patients except two who experienced incorrect device deployment with incomplete LAA closure. Procedure duration halved from first to last procedure performed. The only periprocedural adverse events observed were a myocardial infarction and an in-hospital death due pneumonia. At mean follow-up (166 ± 80 days) all other patients were alive and free from major bleedings and ischaemic strokes. CONCLUSIONS: Our results suggest that the Ultraseal device is a feasible option for LAA occlusion. Notably, the learning curve in this registry was fast, paralleled by extremely low complication rates. These results should be considered hypothesis generating and larger studies are mandatory.

Transcatheter aortic valve implantation in bicuspid anatomy: procedural results with two different types of valves.

BACKGROUND: It is well known that bicuspid valve stenosis can be treated with transcatheter aortic valve implantation (TAVI) even if specific issues can cause problems: dilatation of ascending aorta, possible aorthopathy, eccentricity of the valve and calcium distribution in leaflets and in commissures. We classified Bicuspid aortic valve (BAV) in type 0 (2 cusps and no raphe), and type 1 (2 cusps and one or more raphes). The aim of the present study was to report the results of two types of valve (CoreValve from 2009 to 2016 and Lotus valve from 2014 to 2017) in a consecutive series of BAV patients treated in 2 Italian centers. METHODS: A total of 30 patients with BAV underwent TAVI from September 2009 to March 2017. RESULTS: Mean age was 78±8 years, 54.5% were males and 7.4% had peripheral vasculopathy, 6.5% previous stroke or TIA, 15.6% previous PCI and 9.4% previous coronary artery bypass grafting. Ten patients (30.3%) had a type 1; mean aortic valvular gradient was 57.7±17.7 mmHg; aortic valvular area was 0.7±0.2 mm2, left ventricular ejection fraction was 51.4±10.0% and ascending aorta was 41.0±5.6 mm. Among these 30 patients, 16 of them (group 1) undergone CoreValve implantation and 14 (group 2) undergone Lotus valve implantation. Patients in the first group had a higher Logistic Euroscore (P<0.001) and higher AVA (P=0.026) and valve area CT (P=0.003). Device size in group1 was more often bigger than in group 2 (P<0.001) and postdilatation was never used in the last group. Group 1 had a significant more frequent aortic regurgitation ≥2 assessed with angiography (28.6% vs. 0%; P=0.05). A non-statistically significant higher rate of second valve implantation (6.2% vs. 0%; P=1.00) was also observed. New permanent pacemaker implantation (40.0% vs. 35.7%; P=0.812) was equal in both valves. CONCLUSIONS: Postprocedural aortic regurgitation is still an issue in BAV undergone TAVI when: 1) the annulus is big; 2) when we are using self-expandable valves; and 3) in type 0 valves. Lotus valve, with a higher radial force put in a small annuls seems associated to better procedural outcomes in this subset of patients.

Polymer-free amphilimus-eluting stent versus biodegradable polymer biolimus-eluting stent in patients with and without diabetes mellitus.

OBJECTIVES: This study sought to compare clinical outcome of polymer-free amphilimus-eluting stent (PF-AES) versus biodegradable-polymer biolimus-eluting stent (BD-BES) in "all-comer" diabetes mellitus (DM) and non-DM patients who underwent percutaneous coronary intervention. BACKGROUND: The PF-AES has shown promising preliminary results in patients with DM. METHODS: Data from 2 multicentre-national registries (the ASTUTE and the INSPIRE-1) were used to analyse 1776 patients stratified in non-DM and DM. A double 1:1 propensity-score matched analysis (PF-AES vs. BD-BES) was performed in each group to adjust for clinical and procedural characteristics. Primary stent-efficacy and stent-safety endpoints were 1-year target-lesion revascularization (TLR) and target-lesion failure (TLF, composed of cardiac-death, target-vessel myocardial infarction and any TLR). RESULTS: After propensity-score matching, 850 patients were stratified as non-DM (425 PF-AES/425 BD-BES) and 480 as DM patients (240 PF-AES/240 BD-BES). Both TLF (20 of 425 [5%] vs. 24 of 425 [6%]; Plog-rank=0.527) and TLR (9 of 425 [2%] vs. 18 of 425 [4%]; Plog-rank=0.079) were similar between PF-AES and BD-BES in non-DM patients. In DM, TLF (12 of 240 [5%] vs. 31 of 240 [13%]; Plog-rank=0.002) and TLR (9 of 240 [4%] vs. 21 of 240 [9%]; Plog-rank=0.019) were significantly lower in PF-AES compared to BD-BES. Upon multivariate analysis, the most powerful predictors of TLF were chronic kidney disease in non-DM (OR 4.24, 95% CI: 2.07-8.70, p<0.001) and stent type in DM patients (OR 2.76, 1.36-5.56, p=0.005). CONCLUSIONS: This matched-cohort study suggests that PF-AES has better safety and efficacy profile than BD-BES in patients with DM.

Recurrent cerebral ischemia after patent foramen ovale percutaneous closure in older patients: A two-center registry study.

OBJECTIVES: The aim of this study is to describe the cerebral ischemia recurrence rate after percutaneous patent foramen ovale (PFO) closure in patients older than 55 years and their outcomes, compared with younger patients. BACKGROUND: The registries data and the recent randomized trials about PFO closure are focused on patients younger than 55 years. Little is known about older patients' long-term outcome. METHODS: In total, 458 patients underwent PFO closure for cryptogenic cerebral ischemia and were stratified into an "older" (≥ 55 years, 151 patients) and a "younger" (<55 years, 307 patients) group. RESULTS: Older patients had mean age of 63 ± 6 years and more atrial septum aneurysm (P = 0.05), hypertension, diabetes, and dyslipidemia (P = 0.001). Mean followup was 4.5 ± 2.8 years. Older patients had a higher rate of ischemic recurrence (0.3 vs. 4.0%, P = 0.002), after a mean time of 3.1 ± 2.6 years. The Kaplan-Meier curve confirmed higher event-free survival in the youngers (P = 0.008). None of the patients with ischemic recurrence had significant residual shunt. Age and hypertension were correlated to ischemic recurrence, but age was the only independent predictor at multivariate analysis. CONCLUSIONS: Recurrent cerebral ischemia after PFO closure is more frequent in older patients and could most likely be associated to conditions related to age (atherosclerosis, atrial fibrillation), than to paradoxical embolism. The procedure is as safe as in younger patients.