Feasibility of concomitant left atrial appendage closure and percutaneous coronary intervention in patients with acute coronary syndrome and atrial fibrillation: a randomized pilot study.

The optimal approach for prevention of cardiovascular events and reduction of bleeding in patients with acute coronary syndrome (ACS) and atrial fibrillation (AF) is still controversial. The aim of our study is to asses our single-center experience with concomitant left atrial appendage occlusion (LAAO) and percutaneous coronary intervention (PCI). 50 patients with ACS without ST elevation and history of AF were randomized after successful PCI to LAAO or conventional medical therapy. The primary endpoints were safety and length of hospitalization. The follow-up period was 30 days. The mean procedural times were 113 ± 23 min PCI + LAAO implantation and 39 ± 19 min of PCI only (p < 0.001), while mean fluoroscopy times were 18 ± 8 min and 12 ± 8 min (p < 0.001), respectively. No procedure-related complications were observed. There was no difference observed for length of hospitalization between two groups. LAAO in patients with ACS and AF undergoing PCI appears safe.

Three-months optical coherence tomography analysis of a biodegradable polymer, sirolimus-eluting stent.

OBJECTIVE: We aimed to assess early neointimal healing by optical coherence tomography (OCT) 3 months after implantation of the ultrathin Orsiro® sirolimus-eluting stent with biodegradable polymer. BACKGROUND: New generations of drug-eluting stents with biodegradable polymer have been developed to avoid the continued vascular irritation of durable polymers. METHODS: In this prospective, open-label study, 34 patients received an Orsiro® sirolimus-eluting stent with biodegradable polymer. In a subgroup of patients (n = 15), the intervention was performed under OCT guidance. All patients underwent OCT-examination at three months. The primary endpoint was 3-month neointimal healing (NIH) score, calculated by weighing the presence of filling defects, malapposed and uncovered struts. Secondary endpoint was maturity of tissue coverage at 3 months. RESULTS: At 3 months, NIH score was 13.7 (5.4-22), covered struts per lesion were 90% (84-97%), malapposed struts were 2.7% (0.8-5.4%) and rate of mature tissue coverage was 47% (42-53%). No target lesion failure occurred up to 12 months. Patients with OCT-guided stent implantation demonstrated a trend toward earlier stent healing as demonstrated by superior NIH scores (angio guided: 17.6% [8.8-26.4]; OCT-guided: 9.8% [4.0-15.5]; mean difference -8, [95%CI: -18.7-2.9], P = 0.123). This group had significantly more covered struts per lesion (angio-guided: 86% [82-90]; 95% [92-99]; mean difference 9% [95%CI: 3-15], P = 0.001). CONCLUSION: The Orsiro® sirolimus-eluting stent with biodegradable polymer shows early vascular healing with a high rate of strut coverage at 3-month follow-up. OCT guided stent implantation had a positive impact on early vascular healing.

Incidence of atrial fibrillation detected by continuous rhythm monitoring after acute myocardial infarction in patients with preserved left ventricular ejection fraction: results of the ARREST study.

Aims: Cardiac arrhythmias following acute myocardial infarction (AMI) can be associated with major adverse cardiovascular events. Data on the "real incidence" of post-MI arrhythmias are limited. We aimed to determine the rate and burden of cardiac arrhythmias by the use of insertable cardiac monitors (ICM) in patients with preserved left ventricular ejection fraction (LVEF) after AMI. Methods and results: In this prospective observational study, patients with LVEF ≥40% who underwent PCI within 7 days following AMI were enrolled to receive an ICM. Primary outcome was the incidence of new-onset atrial fibrillation (AF) measured by the ICM during a follow-up of 2 years; results: Of 165 consecutive patients with AMI, 50 (30.3%) eligible patients were recruited (mean age 57.8 ± 8.3, 88% male). During follow-up, AF was the most frequently detected arrhythmia. Twenty-nine (58%, 95% CI: 42-70%) patients developed new-onset AF, with a cumulative rate of all detected arrhythmias of 65%. Median time to the first detected AF episode was 4.8 months and the peak cumulative AF burden was detected between 3 and 6 months. Twenty-seven (93%) out of 29 patients with AF were asymptomatic. Cox regression analysis found that baseline troponin level (hazard ratio [HR] for 1 ng/mL increment: 1.03, 95% CI: 1.01-1.06, P = 0.01) and CHA2DS2-VASc score of 4 (HR: 11.42, 95% CI: 1.01-129.06, P = 0.04) were independent risk factors of new-onset AF post-AMI. Conclusion: AF is a frequent but largely underestimated cardiac arrhythmia after AMI. More rigorous monitoring strategies resulting in crucial medical interventions (e.g. implementation of oral anti-coagulation) are needed. Clinical Trial Registration: http://www.clinicaltrials.gov. Unique identifier: NCT02492243.

A randomized trial of bifurcation stenting technique in chronic total occlusions percutaneous coronary intervention.

BACKGROUND: The optimal strategy to treat bifurcation lesions (BFLs) in a percutaneous coronary intervention (PCI) for chronic total occlusions (CTOs) remains unknown. AIMS: We sought to assess whether T-provisional or mini-crush is appropriate for BFLs within CTO vessels. PATIENTS AND METHODS: From January 2011 to December 2013, patients who underwent successful CTO guidewire crossing and with a BFL within the CTO target vessel were enrolled prospectively and assigned randomly to either T-provisional stenting or the mini-crush technique for BFL treatment. One-year clinical follow-up was performed. Major adverse cardiac and cerebrovascular events (MACCE) were defined as the composite of cardiovascular death, myocardial infarction, target vessel revascularization, and stroke. RESULTS: The prevalence of BFLs was 54.3%. A total of 146 patients with BFLs within CTO vessel were enrolled prospectively and assigned randomly to either T-provisional stenting (N=73) or the mini-crush technique (N=73). Angiographic and clinical success rates were similar in the two groups: 91.8 versus 97.2% (P=0.27) and 91.8 versus 94.5% (P=0.67), respectively.Although T-provisional stenting was associated with a nonsignificantly lower incidence of MACCE in case of BFLs located far from the CTO (9.3 vs. 22.2%; P=0.426), the mini-crush technique resulted in higher MACCE-free survival at 1 year in the presence of BFLs within the CTO body or close to the proximal or the distal cap (89.1 vs. 64.9%; P=0.007). CONCLUSION: The mini-crush technique appeared to be associated with improved 1-year clinical and angiographic outcomes, particularly when used to treat BFLs located within the CTO body or close to the proximal or the distal cap.

Mid-term outcome of biolimus-eluting stents with biodegradable polymer: results from a multinational prospective 'all-comers' registry.

BACKGROUND: The Nobori biolimus-eluting stent (BES) is a biodegradable polymer drug-eluting stent (DES). Several studies have shown its noninferiority in comparison with durable polymer DES. AIM: We sought to investigate the efficacy and the safety of Nobori BES in an all-comer population undergoing a percutaneous coronary intervention. PATIENTS AND METHODS: A total of 12 912 patients with 19 947 coronary lesions, undergoing percutaneous coronary intervention with Nobori BES implantation at 200 centres around the world between August 2010 and December 2015, were included in this prospective registry. Patients were stratified into four groups according to the total stent length, with cutoffs at 18, 24 and 28 mm. The primary endpoint was the occurrence of major adverse cardiac events defined as the composite of cardiac death, target vessel myocardial infarction and clinically driven target lesion revascularization at 1 year. RESULTS: At 1 year, the major adverse cardiac events rate was the highest (4.6%) in the fourth quartile of stent length (>28 mm), whereas the overall rate of the primary endpoint in the all cohort was 3.5%. Both target lesion revascularization and target vessel revascularization rates were significantly higher in patients with longer stent length was implanted (all P<0.05). The incidence of definite and probable stent thrombosis at 1 year was 0.5% in all cohort and similar across the four groups (varying from 0.4 to 0.7%, all P=NS). CONCLUSION: Our data confirmed the efficacy and the safety of the Nobori BES in routine clinical practice. Longer stent length is associated with a higher risk of adverse cardiac events, and yet, this risk is comparable with that of other DES.

Does left atrial appendage closure improve the success of pulmonary vein isolation? Results of a randomized clinical trial.

PURPOSE: The combination of left atrial appendage (LAA) occlusion with pulmonary vein isolation (PVI) potentially represents a comprehensive treatment for atrial fibrillation (AF), controlling symptoms while at the same time reducing the risk of stroke and the need for chronic anticoagulation. The aim of this randomized clinical trial was to assess the impact of LAA closure added to PVI in patients with high-risk AF. METHODS: Patients with a history of symptomatic paroxysmal or persistent AF refractory to ≥ 2 antiarrhythmic drugs, CHA2DS2-VASc score ≥ 2, and HAS-BLED score ≥ 3 were randomized to PVI-only (n = 44) or PVI with LAA closure (n = 45). RESULTS: Six patients in PVI + LAA closure group crossed over to PVI-only group due to failure of LAA closure device implantation. On-treatment comparisons at the 24 month follow-up revealed that 33 (66%) of the 50 PVI group and 23 (59%) of the 39 PVI with LAA closure group were AF-free on no antiarrhythmic drugs (p = 0.34). The PVI + LAA closure treatment was significantly associated with a higher AF burden during the blanking period: 9.7 ± 10.8 vs 4.2 ± 4.1% (p = 0.004). At the end follow-up, there were no serious complications and no strokes or thromboembolic events in either group. CONCLUSIONS: The combination of LAA closure device implantation with PVI was safe but was not observed to influence the success of PVI in patients with symptomatic refractory AF. Early AF after ablation, however, is increased by LAA closure. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01695824.