Routine revascularization with percutaneous coronary intervention in patients with coronary artery disease undergoing transcatheter aortic valve implantation - the third nordic aortic valve intervention trial - NOTION-3.

BACKGROUND: Coronary artery disease (CAD) frequently coexists with severe aortic valve stenosis (AS) in patients planned for transcatheter aortic valve implantation (TAVI). How to manage CAD in this patient population is still an unresolved question. In particular, it is still not known whether fractional flow reserve (FFR) guided revascularization with percutaneous coronary intervention (PCI) is superior to medical treatment for CAD in terms of clinical outcomes. STUDY DESIGN: The third Nordic Aortic Valve Intervention (NOTION-3) Trial is an open-label investigator-initiated, multicenter multinational trial planned to randomize 452 patients with severe AS and significant CAD to either FFR-guided PCI or medical treatment, in addition to TAVI. Patients are eligible for the study in the presence of at least 1 significant PCI-eligible coronary stenosis. A significant stenosis is defined as either FFR ≤0.80 and/or diameter stenosis >90%. The primary end point is a composite of first occurring all-cause mortality, myocardial infarction, or urgent revascularization (PCI or coronary artery bypass graft performed during unplanned hospital admission) until the last included patient have been followed for 1 year after the TAVI. SUMMARY: NOTION-3 is a multicenter, multinational randomized trial aiming at comparing FFR-guided revascularization vs medical treatment of CAD in patients with severe AS planned for TAVI.

Short- and long-interval intracortical inhibition in EPM1 is related to genotype.

OBJECTIVE: Progressive myoclonic epilepsy type 1 (EPM1) is caused by biallelic alterations in the CSTB gene, most commonly dodecamer repeat expansions. Although transcranial magnetic stimulation (TMS)-induced long-interval intracortical inhibition (LICI) was previously reported to be normal in EPM1, short-interval intracortical inhibition (SICI) was reduced. We explored the association between these measures and the clinical and genetic features in a separate group of patients with EPM1. METHODS: TMS combined with electromyography was performed under neuronavigation. LICI was induced with an inter-stimulus interval (ISI) of 100 ms, and SICI with ISIs of 2 and 3 ms, and their means (mSICIs) were expressed as the ratio of conditioned to unconditioned stimuli. LICI and mSICI were compared between patients and controls. Nonparametric correlation was used to study the association between inhibition and parameters of clinical severity, including the Unified Myoclonus Rating Scale (UMRS); among patients with EPM1 due to biallelic expansion repeats, also the association with the number of repeats was assessed. RESULTS: The study protocol was completed in 19 patients (15 with biallelic expansion repeats and 4 compound heterozygotes), and 7 healthy, age- and sex-matched control participants. Compared to controls, patients demonstrated significantly less SICI (median mSICI ratio 1.18 vs 0.38; p < .001). Neither LICI nor SICI was associated with parameters of clinical severity. In participants with biallelic repeat expansions, the number of repeats in the more affected allele (greater repeat number [GRN]) correlated with LICI (rho = 0.872; p < .001) and SICI (rho = 0.689; p = .006). SIGNIFICANCE: Our results strengthen the finding of deranged γ-aminobutyric acid (GABA)ergic inhibition in EPM1. LICI and SICI may have use as markers of GABAergic impairment in future trials of disease-modifying treatment in this condition. Whether a higher number of expansion repeats leads to greater GABAergic impairment warrants further study.

Ability to remotely monitor atrial high-rate episodes using a single-chamber implantable cardioverter-defibrillator with a floating atrial sensing dipole.

AIMS: To allow timely initiation of anticoagulation therapy for the prevention of stroke, the European guidelines on atrial fibrillation (AF) recommend remote monitoring (RM) of device-detected atrial high-rate episodes (AHREs) and progression of arrhythmia duration along pre-specified strata (6 min…<1 h, 1 h…<24 h, ≥ 24 h). We used the MATRIX registry data to assess the capability of a single-lead implantable cardioverter-defibrillator (ICD) with atrial sensing dipole (DX ICD system) to follow this recommendation in patients with standard indication for single-chamber ICD. METHODS AND RESULTS: In 1841 DX ICD patients with daily automatic RM transmissions, electrograms of first device-detected AHREs per patient in each duration stratum were adjudicated, and the corresponding positive predictive values (PPVs) for the detections to be true atrial arrhythmia were calculated. Moreover, the incidence and progression of new-onset AF was assessed in 1451 patients with no AF history. A total of 610 AHREs ≥6 min were adjudicated. The PPV was 95.1% (271 of 285) for episodes 6min…<1 h, 99.6% (253/254) for episodes 1 h…<24 h, 100% (71/71) for episodes ≥24 h, or 97.5% for all episodes (595/610). The incidence of new-onset AF was 8.2% (119/1451), and in 31.1% of them (37/119), new-onset AF progressed to a higher duration stratum. Nearly 80% of new-onset AF patients had high CHA2DS2-VASc stroke risk, and 70% were not on anticoagulation therapy. Age was the only significant predictor of new-onset AF. CONCLUSION: A 99.7% detection accuracy for AHRE ≥1 h in patients with DX ICD systems in combination with daily RM allows a reliable guideline-recommended screening for subclinical AF and monitoring of AF-duration progression.

Reperfusion therapies and in-hospital outcomes for ST-elevation myocardial infarction in Europe: the ACVC-EAPCI EORP STEMI Registry of the European Society of Cardiology.

AIMS: The aim of this study was to determine the contemporary use of reperfusion therapy in the European Society of Cardiology (ESC) member and affiliated countries and adherence to ESC clinical practice guidelines in patients with ST-elevation myocardial infarction (STEMI). METHODS AND RESULTS: Prospective cohort (EURObservational Research Programme STEMI Registry) of hospitalized STEMI patients with symptom onset <24 h in 196 centres across 29 countries. A total of 11 462 patients were enrolled, for whom primary percutaneous coronary intervention (PCI) (total cohort frequency: 72.2%, country frequency range 0-100%), fibrinolysis (18.8%; 0-100%), and no reperfusion therapy (9.0%; 0-75%) were performed. Corresponding in-hospital mortality rates from any cause were 3.1%, 4.4%, and 14.1% and overall mortality was 4.4% (country range 2.5-5.9%). Achievement of quality indicators for reperfusion was reported for 92.7% (region range 84.8-97.5%) for the performance of reperfusion therapy of all patients with STEMI <12 h and 54.4% (region range 37.1-70.1%) for timely reperfusion. CONCLUSIONS: The use of reperfusion therapy for STEMI in the ESC member and affiliated countries was high. Primary PCI was the most frequently used treatment and associated total in-hospital mortality was below 5%. However, there was geographic variation in the use of primary PCI, which was associated with differences in in-hospital mortality.

Autonomic responses to tooth clenching and handgrip test.

OBJECTIVE: The aim was to study the differences in autonomic nervous system activation between maximal tooth clenching task and handgrip test during and after the tasks. Also, the possible activation of trigeminocardiac reflex during the clenching task was explored. MATERIAL AND METHODS: We compared autonomic responses to maximal tooth clenching and handgrip in 28 participants. Responses in heart rate variability, heart rate, and blood pressure were evaluated before, during, and after tests. Although all study participants were considered healthy during recruitment, 14 of them showed painful temporomandibular disorders in the clinical examination, which was taken into account in the analyses. RESULTS: Handgrip and tooth clenching caused similar autonomic responses. However, tooth clenching seemed to activate the trigeminocardiac reflex shown as clenching-related vagal activation. The painful signs of temporomandibular disorders may interfere with the heart rate variability both at the baseline and during both tests causing significant variation in them. CONCLUSIONS: Both handgrip and tooth clenching affect the autonomic nervous system function. Tooth clenching differs from the handgrip due to trigeminocardiac reflex. Painful signs of temporomandibular disorders are interfering with the results of the tests and maybe underestimated in the studies of autonomic responses to both tasks.

Epitranscriptomics of Ischemic Heart Disease-The IHD-EPITRAN Study Design and Objectives.

Epitranscriptomic modifications in RNA can dramatically alter the way our genetic code is deciphered. Cells utilize these modifications not only to maintain physiological processes, but also to respond to extracellular cues and various stressors. Most often, adenosine residues in RNA are targeted, and result in modifications including methylation and deamination. Such modified residues as N-6-methyl-adenosine (m6A) and inosine, respectively, have been associated with cardiovascular diseases, and contribute to disease pathologies. The Ischemic Heart Disease Epitranscriptomics and Biomarkers (IHD-EPITRAN) study aims to provide a more comprehensive understanding to their nature and role in cardiovascular pathology. The study hypothesis is that pathological features of IHD are mirrored in the blood epitranscriptome. The IHD-EPITRAN study focuses on m6A and A-to-I modifications of RNA. Patients are recruited from four cohorts: (I) patients with IHD and myocardial infarction undergoing urgent revascularization; (II) patients with stable IHD undergoing coronary artery bypass grafting; (III) controls without coronary obstructions undergoing valve replacement due to aortic stenosis and (IV) controls with healthy coronaries verified by computed tomography. The abundance and distribution of m6A and A-to-I modifications in blood RNA are charted by quantitative and qualitative methods. Selected other modified nucleosides as well as IHD candidate protein and metabolic biomarkers are measured for reference. The results of the IHD-EPITRAN study can be expected to enable identification of epitranscriptomic IHD biomarker candidates and potential drug targets.

An Overview of Strategies for Reducing Upper Extremity Physical Exposure Associated With Floor Mopping: A Systematic Review.

OBJECTIVE: This systematic review synthesizes literature on upper extremity physical exposure associated with floor mopping, in order to (a) assess the impact of changes in mopping systems on physical exposure and (b) propose recommendations for strategies to reduce exposure. BACKGROUND: Floor-cleaning tools and equipment have undergone major improvements. Existing studies have focused on mop design modifications and cleaning efficiency. However, less is known about strain responses caused by modern tools and methods. METHOD: Studies from 1987 to February 2017 were identified by electronic and manual search. All selected studies underwent a quality assessment. The evidence was organized into categories representing different strategies for reducing exposure. The levels of evidence were determined using a best evidence synthesis approach. RESULTS: Eleven studies were included. Based on the review findings, currently there is moderate evidence suggesting that reduced physical exposure has been achieved through development of mopping systems. Levels of evidence for strategies associated with positive effects on physical exposure were: moderate evidence for mop design and handle type, insufficient evidence for mopping technique, and mixed evidence for mopping methods and environment modifications. Therefore, the present study suggests the use of adjustable mop handles as a strategy for reducing physical exposure. CONCLUSION: A more comprehensive approach to reducing physical exposure concerning floor mopping work is necessary. APPLICATION: Knowledge regarding physical exposure reduction can be applied as the basis for decision making in cleaning practice. Information can be incorporated into future research regarding development of floor-cleaning methods.

Evaluation of the Effect of Bariatric Surgery-Induced Weight Loss on Knee Gait and Cartilage Degeneration.

The objective of the study was to investigate the effects of bariatric surgery-induced weight loss on knee gait and cartilage degeneration in osteoarthritis (OA) by combining magnetic resonance imaging (MRI), gait analysis, finite element (FE) modeling, and cartilage degeneration algorithm. Gait analyses were performed for obese subjects before and one-year after the bariatric surgery. FE models were created before and after weight loss for those subjects who did not have severe tibio-femoral knee cartilage loss. Knee cartilage degenerations were predicted using an adaptive cartilage degeneration algorithm which is based on cumulative overloading of cartilage, leading to iteratively altered cartilage properties during OA. The average weight loss was 25.7±11.0 kg corresponding to a 9.2±3.9 kg/m2 decrease in body mass index (BMI). External knee rotation moment increased, and minimum knee flexion angle decreased significantly (p < 0.05) after weight loss. Moreover, weight loss decreased maximum cartilage degeneration by 5±23% and 13±11% on the medial and lateral tibial cartilage surfaces, respectively. Average degenerated volumes in the medial and lateral tibial cartilage decreased by 3±31% and 7±32%, respectively, after weight loss. However, increased degeneration levels could also be observed due to altered knee kinetics. The present results suggest that moderate weight loss changes knee kinetics and kinematics and can slow-down cartilage degeneration for certain patients. Simulation results also suggest that prediction of cartilage degeneration is subject-specific and highly depend on the altered gait loading, not just the patient's weight.

Autonomic responses to tooth clenching in migraineurs-augmented trigeminocardiac reflex?

BACKGROUND: Systemic autonomic changes are well known in migraineurs. Also, masticatory disorders are reported to be associated with migraine. However, if those phenomena are interrelated, and how, is unclear. Moreover, the knowledge on the autonomic responses to masticatory stimuli in migraineurs is limited. OBJECTIVE: To investigate tooth clenching-related cardiac autonomic regulation in migraineurs. METHODS: We compared maximal tooth clenching-induced systemic autonomic responses, indicated by heart rate variability and blood pressure changes, in headache-free migraineurs (n = 17) and control subjects (n = 22). RESULTS: Levels of high-frequency power, reflecting vagal activity, were lower in migraineurs at baseline but increased after tooth clenching whereas in controls they returned to baseline (P < 0.05, mixed model analysis). In multivariate regression model, the presence of migraine predicted the baseline levels of low- and high-frequency power and sympathovagal balance, and the post-test increase in high-frequency power, with the attack frequency and side of headache as the modifiers of the measured changes in migraineurs. The painful signs of temporomandibular disorders, found in clinical oral examination, enhanced both maximal changes in RR intervals and post-test vagal responses to tooth clenching only in migraineurs. CONCLUSION: The enhanced post-clenching vagal activation may represent a marker of the augmented trigeminocardiac reflex to stimulation of trigeminal area, sensitised in migraineurs. Our results support an involvement of autonomic mechanisms in migraine pathophysiology and are interesting in terms of interactions between migraine and masticatory disorders, elucidating one potential way how masticatory disorders may aggravate migraine.

Time in therapeutic range and major adverse outcomes in atrial fibrillation patients undergoing percutaneous coronary intervention: The Atrial Fibrillation Undergoing Coronary Artery Stenting (AFCAS) registry.

BACKGROUND: Combination of oral anticoagulation (OAC) and antiplatelets is used in atrial fibrillation (AF) patients undergoing percutaneous coronary intervention and stent (PCI-S) procedure but is associated with increased bleeding when triple antithrombotic therapy (TAT) is used. Our aim was to analyze the impact of time in therapeutic range (TTR) on outcomes, in patients prescribed with TAT. METHODS: Ancillary analysis from the AFCAS registry in patients assigned to TAT. TTR was calculated with Rosendaal method. Outcomes were analyzed according to TTR tertiles (T1 [≤56.8%] vs. T2 [56.9-93.8%] vs. T3 [≥93.9%]). Major bleeding was the primary outcome. RESULTS: Of 963 patients enrolled, 470(48.8%) were prescribed with TAT at discharge and qualified for this analysis. Median [IQR] TTR was 80.0% [45.3-100%]. After 359 [341-370] days, major bleeding rates were progressively lower with increasing TTR tertiles (T1 vs. T2 vs. T3: 10.3% vs. 4.7% vs. 2.3%, P=.006). Kaplan-Meier analysis demonstrated a progressively lower risk for major bleeding across tertiles (P=.006). Patients in the highest TTR tertile had a non-significant lower risk for major adverse coronary and cerebrovascular events (MACCE) (log-rank: 4.905, P=.086). Cox regression analysis showed that T2 and T3 were inversely associated with major bleeding (hazard ratio [HR]:0.39, P=.050 and HR: 0.21, P=.005). Continuous TTR was inversely associated with major bleeding (HR: 0.98, P<.001). For MACCE, adjusted Cox analysis found a non-significant lower risk for T3 (HR: 0.64, P=.128). CONCLUSIONS: In AF patients undergoing PCI-S prescribed TAT, good quality anticoagulation control (as reflected by TTR) was closely related to bleeding outcomes during follow-up. Despite some suggestive trends for an inverse relationship between TTR and MACCE, no definitive conclusions can be drawn, and further large studies are needed.

Impact of Calcified Target Lesions on the Outcome of Percutaneous Coronary Intervention for Acute Coronary Syndrome: Insights From the BASE ACS Trial.

OBJECTIVES: We performed a post hoc analysis of outcome in patients with, versus those without, calcified target lesions from the BASE ACS trial. BACKGROUND: The outcome of contemporary stent implantation in patients with calcified lesions presenting with acute coronary syndrome is unknown. METHODS: The BASE ACS trial randomized 827 patients (1:1) presenting with acute coronary syndrome to receive either titanium-nitride-oxide-coated stents or everolimus-eluting stents. Calcified lesions were defined as moderate or severe calcification in the vessel wall by coronary angiography. The primary endpoint was major adverse cardiac events (MACE): a composite of cardiac death, non-fatal myocardial infarction or ischemia-driven target lesion revascularization. Follow-up was planned at 12 months, and yearly thereafter for up to 7 years. RESULTS: Of 827 patients enrolled in the trial, 352 (42.6%) had calcified target lesions. Median follow-up was 5.0 years. The incidence of MACE was higher in patients with, versus those without, calcified target lesions (19.6% vs. 12.2%, respectively, P = 0.004). This was driven by more frequent cardiac death and non-fatal myocardial infarction events (P < 0.05, both). The rates of ischemia-driven target lesion revascularization were comparable (P > 0.05). MACE and the other endpoints were comparable between the 2 propensity-score matched subgroups (P > 0.05 for all). Hypertension and smaller vessel size independently predicted MACE in patients treated for calcified lesions. CONCLUSIONS: Patients presenting with acute coronary syndrome who were treated for calcified lesions had worse long-term clinical outcome, compared with those treated for non-calcified lesions, mainly due to more frequent safety events. In the propensity score-matched analysis, the outcome was comparable.

Neointimal Healing Evaluated by Optical Coherence Tomography after Drug-Eluting Absorbable Metal Scaffold Implantation in de novo Native Coronary Lesions: Rationale and Design of the Magmaris-OCT Study.

OBJECTIVES: We sought to explore neointimal healing assessed by optical coherence tomography (OCT) following implantation of the Magmaris sirolimus-eluting absorbable metal scaffold. METHODS: The Magmaris-OCT is a prospective, multicenter, single-arm observational clinical study, intended to enrol 60 consecutive patients with up to 2 de novo native coronary lesions, each located in different major epicardial vessels, with a reference vessel diameter of 2.5-3.5 mm, and a maximum lesion length of 20 mm. Patients will undergo Magmaris scaffold implantation in the target lesion, according to the standard practice. Clinical follow-up will take place at 30 days, and at 3, 6, 9, and 12 months. For invasive-imaging follow-up, patients will be classified into 3 groups: cohort A will be scheduled for follow-up at 3 months, cohort B at 6 months, and cohort C at 12 months. Invasive imaging will include quantitative coronary angiography, OCT evaluation, and coronary flow reserve measurement. The primary end point will be the percentage of uncovered scaffold struts assessed by OCT at the prespecified follow-up. CONCLUSIONS: This study will provide insight into the short- and mid-term healing properties following Magmaris scaffold implantation, with special emphasis on the neointimal coverage of scaffold struts.

Outcome of poor initial TIMI flow in patients presenting with acute coronary syndrome.

OBJECTIVES: We explored the predictors and outcome of poor, versus good, initial TIMI flow in patients with acute coronary syndrome (ACS). DESIGN: We performed post-hoc analysis of a randomized trial of patients presenting with ACS who received 2 comparative stents. Poor initial TIMI flow was defined as baseline TIMI flow grade 0/1 at the initial coronary angiography. The primary endpoint was major adverse cardiac events (MACE): a composite of cardiac death, non-fatal myocardial infarction or ischemia-driven target lesion revascularization. Stent thrombosis (ST) was adjudicated according to the criteria of definite ST described by the Academic Research Consortium. Propensity score-matched analysis was performed. We report data after 5-year follow-up. RESULTS: Of 827 patients enrolled, 279 (33.7%) had initial TIMI 0/1 flow. Median follow-up duration was 5.0 years. Presentation by ST-elevation myocardial infarction and target vessel other than left anterior descending artery predicted initial TIMI 0/1 flow. MACE rate was comparable between the 2 subgroups (14% versus 15.9%, in patients with poor versus good initial TIMI flow, respectively, p = .46). Individual endpoints were comparable (p > .05 for all). Definite ST was more frequent in patients with initial TIMI 0/1 flow (3.6% versus 1.5%, respectively, p = .048). This was driven by more frequent early events (30 days) (p = .036); late/very late events were comparable (p = 1.0). CONCLUSIONS: Predictors of poor initial TIMI flow included presentation by ST-elevation myocardial infarction, and target vessel other than left anterior descending artery. Definite ST occurred more in patients with poor, versus good, initial TIMI flow, mainly driven by difference in early events.

Optical coherence tomography follow-up 18 months after titanium-nitride-oxide-coated versus everolimus-eluting stent implantation in patients with acute coronary syndrome.

Background Inadequate neointimal coverage of stent struts is associated with late stent thrombosis. Purpose To demonstrate the extent of neointimal coverage and strut malapposition in titanium-nitride-oxide-coated bioactive stents (BAS) versus everolimus-eluting stents (EES) by optical coherence tomography (OCT) performed at 18-month follow-up. Material and Methods In the BASE-ACS trial, 827 patients presenting with acute coronary syndrome were randomized to receive either BAS or EES. Forty patients (20 BAS, 20 EES) underwent OCT at 18-month follow-up for evaluation of stent strut coverage, malapposition, and neointimal hyperplasia (NIH). Primary endpoint was binary stent strut coverage (ratio of covered struts to all analyzed struts multiplied by 100). Co-primary endpoint was the percentage of malapposed struts. Results We analyzed 3465 struts in 330 cross-sections of BAS and 3327 struts in 316 cross-sections of EES. Binary stent strut coverage, based on strut-level analysis, was higher with BAS versus EES (99.5% versus 94.2%, respectively; P < 0.001), the strut-level percentage of malapposed struts was lower with BAS (0.6% versus 2.5%, respectively; P < 0.001). Yet, the mean NIH thickness was greater with BAS (237 ± 125 versus 108 ± 62 µm, respectively; P < 0.001). Conclusion In the current post-hoc analysis with OCT performed at 18 months, binary strut coverage, based on strut-level analysis, was higher with BAS versus EES; strut-level malapposed struts were fewer with BAS; yet, BAS induced thicker NIH.

Clinical outcome of titanium-nitride-oxide-coated cobalt-chromium stents in patients with de novo coronary lesions: 12-month results of the OPTIMAX first-in-man study.

OBJECTIVES: We explored the 12-month clinical outcome of the titanium-nitride-oxide-coated OPTIMAX stent based on cobalt-chromium platform. BACKGROUND: The OPTIMAX stent demonstrated a satisfactory 6-month clinical outcome in de novo coronary lesions. METHODS: We enrolled 224 consecutive symptomatic patients with significant (50%) stenosis in de novo coronary lesions, who were treated with OPTIMAX stent implantation. The primary endpoint was major adverse cardiac events at 12-month follow-up, defined as a composite of cardiac death, non-fatal myocardial infarction (MI), or ischemia-driven target lesion revascularization (TLR). Stent thrombosis was adjudicated according to the definition of the Academic Research Consortium. RESULTS: The mean age of the cohort was 67 ± 8 years (75% males). Patients presented with acute coronary syndrome in 62.1%. Radial access was used in 92%; complex (type B and C) lesions were treated in 79.9%. Both procedural and clinical success occurred in 100% of the cases. The mean follow-up period was 366 ± 22 days. At 12-month follow-up, the primary endpoint occurred in 14 (6.3%) patients. Cardiac death occurred in three (1.3%) patients, non-fatal MI in seven (3.1%) patients, and ischemia-driven TLR in seven (3.1%) patients. No definite stent thrombosis occurred. CONCLUSIONS: In the current prospective observational study, implantation of the OPTIMAX stent demonstrated an adequate 12-month clinical outcome, with a low rate of major adverse cardiac events, and no stent thrombosis.

4-Year outcome of bioactive stents versus everolimus-eluting stents in acute coronary syndrome.

OBJECTIVES: The BASE-ACS trial demonstrated non-inferiority of titanium-nitride-oxide-coated bioactive stents (BAS), versus everolimus-eluting stents (EES), for major adverse cardiac events (MACE) at 1- and 2-year follow-up, in patients with acute coronary syndrome (ACS). We presented the 4-year outcome of the BASE-ACS trial. DESIGN: We randomized 827 patients with ACS to receive either BAS (417) or EES (410). MACE was a composite of cardiac death, non-fatal myocardial infarction (MI) or ischemia-driven target lesion revascularization (TLR) at 12-month follow-up. Analyses were performed by intention to treat. Follow-up was planned at 12 months, and yearly thereafter for 5 years. RESULTS: Four-year clinical follow-up was completed in 753 (91.1%) patients. At 4 years, BAS were non-inferior to EES for MACE (14.7% versus 17.8%, respectively; p = 0.24 for superiority; p = 0.001 for non-inferiority). Non-fatal MI was less frequent with BAS (5.0% versus 9.2%, respectively; p = 0.025). Cardiac death and ischemia-driven TLR were comparable (2.9% versus 3.5%, and 8.6% versus 9.2%; p = 0.62 and p = 0.80, respectively). Independent predictors of MACE were calcified lesions (HR 1.54, p = 0.021), the number of vessels treated (HR 1.53, p = 0.025), and reference vessel diameter (HR 0.54, p = 0.006). CONCLUSIONS: In patients presenting with ACS, BAS was associated with a clinical outcome non-inferior to EES at 4-year follow-up.

Transcatheter leadless pacemaker implantation in a patient with a transvenous dual-chamber pacemaker already in place.

An 83-year-old lady had a DDDR pacemaker inserted in 1997 for symptomatic atrioventricular block. She underwent battery replacement in 2008. In 2010, she developed atrial fibrillation; the pacemaker was switched to VVIR mode. During the last 2years, ventricular lead threshold increased progressively. In December 2015, she presented for elective battery replacement. After successful battery replacement, the ventricular lead threshold remained high; therefore, we implanted a leadless transcatheter pacemaker, via femoral vein access, using a dedicated catheter delivery system. Electrical measurements at this stage revealed a pacing threshold of 0.28V at 0.24msec, and an impedance of 650Ω.

Early neointimal coverage and vasodilator response following biodegradable polymer sirolimus-eluting vs. durable polymer zotarolimus-eluting stents in patients with acute coronary syndrome ­HATTRICK-OCT trial.

BACKGROUND: Patients at high bleeding risk would benefit from a shorter dual antiplatelet therapy after PCI. Compared to first-generation devices, the design of newer generation drug-eluting stents may facilitate more rapid anatomical and functional healing of stented vessel based on thinner stent platforms, biodegradable/biocompatible polymers and rapid drug elution. METHODS AND RESULTS: Forty-four non-diabetic patients with acute coronary syndrome (ACS) and culprit lesion in the LAD were randomized to receive either biodegradable polymer sirolimus-eluting stent (BP-SES) or durable polymer zotarolimus-eluting stent (DP-ZES). Neointimal strut coverage was examined using optical coherence tomography, and vasodilator response on invasive thermodilution-derived coronary flow reserve (CFR) at 3-month follow-up. The primary endpoints were percent uncovered struts and CFR. A total of 425 cross-sections (4,897 struts) were analyzed in the BP-SES group, and 425 cross-sections (5,467 struts) in the DP-ZES group. The percent uncovered struts was lower in the BP-SES group compared with the DP-ZES group, both at strut level (3.9% vs. 8.9%, respectively, P<0.001), and stent level (3.9 ± 3.2% vs. 8.9 ± 6.9%, respectively, P=0.019). No significant difference was found between the 2 groups regarding CFR (3.0 ± 1.3 vs. 3.2 ± 1.0, respectively, P>0.05). CONCLUSIONS: In non-diabetic patients with ACS, BP-SES provided slightly better stent strut coverage at 3 months compared with DP-ZES, but neither stent was fully covered. No difference in vasodilator response was seen.

Excellent very early neointimal coverage of bioactive stents by optical coherence tomography.

OBJECTIVES: In a prospective study, we explored the extent of neointimal coverage of stent struts by optical coherence tomography 14 days following the implantation of bioactive stents in an unselected cohort. DESIGN: We enrolled 15 consecutive patients who underwent bioactive stent implantation. Optical coherence tomography images were obtained at 14-day follow-up. Morphometric analysis, strut coverage, strut apposition, neointimal hyperplasia, and possible thrombosis were evaluated at 1-mm intervals. Binary stent strut coverage was defined as the percentage of covered struts of all analyzed struts. RESULTS: Patients underwent optical coherence tomography examination at an average of 14.5 ± 2.3 days following stent implantation. Mean age was 62 ± 11 years; 86.7% were males; 26.7% diabetic. Three-hundred eighteen cross-sections were analyzed, including 2935 struts, an average of 9.2 ± 3 struts per cross-section. Binary stent strut coverage was 96.3%; the prevalence of malapposed struts 1.8%. No thrombi were detected. Mean neointimal hyperplasia thickness was 71.5 ± 53.7 µm. CONCLUSIONS: In the current evaluation by optical coherence tomography at 14-day follow-up after bioactive stent implantation in an unselected cohort, binary stent strut coverage was fairly adequate, and the prevalence of malapposed struts was low.