5-Year Results From the AMPLATZER Amulet Left Atrial Appendage Occluder Randomized Controlled Trial.

Background: The Amulet IDE trial (AMPLATZER Amulet Left Atrial Appendage Occluder [LAAO] Investigational Device Exemption [IDE] Trial) evaluated the safety and effectiveness of the Amulet occluder (Abbott) in patients with nonvalvular atrial fibrillation. The Amulet IDE trial is the largest randomized LAAO trial, comparing the Amulet occluder with the Watchman 2.5 device (Boston Scientific).

Sex-Based Differences in Outcomes Following Peripheral Artery Revascularization: Insights From VOYAGER PAD.

Background Despite high female prevalence of peripheral artery disease (PAD), little is known about sex-based outcomes after lower extremity revascularization (LER) for symptomatic PAD. The effects of rivaroxaban according to sex following LER have not been fully reported. Methods and Results In VOYAGER PAD (Vascular Outcomes Study of ASA [acetylsalicylic acid] Along with Rivaroxaban in Endovascular or Surgical Limb Revascularization for Peripheral Artery Disease), low-dose rivaroxaban versus placebo on a background of aspirin reduced the composite primary efficacy outcome of cardiovascular and limb events in patients with PAD undergoing LER.

Improvement in walking impairment following surgical and endovascular revascularization: Insights from VOYAGER PAD.

Background: Peripheral artery disease (PAD) affects 200 million people worldwide and is associated with impaired quality of life, increased morbidity, and mortality. Supervised exercise therapy (SET) and lower-extremity revascularization (LER) are both proven strategies to improve patient symptoms. Short and long-term functional outcomes after LER for symptomatic PAD in a large, international cohort have not previously been described.

Prevention of arterial and venous thrombotic events in symptomatic peripheral arterial disease patients after lower extremity revascularization in the VOYAGER PAD trial: Dual anticoagulant/antiplatelet regimen vs antiplatelet therapy alone.

Background: Vascular disease burden after lower extremity revascularization (LER) comprises more than the first event, more vascular beds than the local arteries, and more than one clinical event type.

Objectives: Assess total arterial and venous thrombotic burden after LER for symptomatic peripheral artery disease (PAD) and effect of low-dose anticoagulation added to low-dose antiplatelet therapy.

Patients/methods: VOYAGER PAD randomized 6564 symptomatic PAD patients undergoing LER to rivaroxaban 2.

Circulating Monocyte Subsets Are Associated With Extent of Myocardial Injury but Not With Type of Myocardial Infarction.

Inflammation is a hallmark of the period after a myocardial infarction (MI) that is either promoted or resolved by distinct subtypes of circulating inflammatory cells. The three main monocyte subpopulations play different roles inflammation. This study examined whether the type of MI (type 1 or type 2) or the extent of myocardial injury is associated with differences in monocyte subpopulations.

Reduction in Acute Limb Ischemia With Rivaroxaban Versus Placebo in Peripheral Artery Disease After Lower Extremity Revascularization: Insights From VOYAGER PAD.

Background: Patients with peripheral artery disease (PAD) are at heightened risk of acute limb ischemia (ALI), a thrombotic event associated with amputation, disability, and mortality. Previous lower extremity revascularization (LER) is associated with increased ALI risk in chronic PAD. However, the pattern of risk, clinical correlates, and outcomes after ALI early after LER are not well-studied, and effective therapies to reduce ALI post-LER are lacking.

Total Ischemic Event Reduction With Rivaroxaban After Peripheral Arterial Revascularization in the VOYAGER PAD Trial.

Background: Patients with peripheral artery disease (PAD) undergoing lower extremity revascularization (LER) are at high risk of major adverse limb and cardiovascular events. The VOYAGER PAD (Efficacy and Safety of Rivaroxaban in Reducing the Risk of Major Thrombotic Vascular Events in Subjects With Symptomatic Peripheral Artery Disease Undergoing Peripheral Revascularization Procedures of the Lower Extremities) trial demonstrated that rivaroxaban 2.5 mg twice daily reduced first events by 15%.

Direct oral anticoagulants in point-of-care monitoring: an ex-vivo study.

Background: Anticoagulatory activity of direct oral anticoagulants (DOACs) is not routinely measurable by point-of-care monitoring. Thus, the aim of this study was to evaluate the influence of dabigatran/rivaroxaban on point-of-care testing.

Methods: Samples from 34 participants under DOAC therapy were drawn at two time points.

Procedural and Short-Term Results With the New Watchman FLX Left Atrial Appendage Occlusion Device.

Objectives: This study sought to report early experience with the new-generation Watchman FLX device (Boston Scientific, Marlborough, Massachusetts).

Background: The new-generation Watchman FLX features a reduced height, improved anchoring and fabric coverage, and a closed distal end. These design modifications aim to simplify implantation, allow full recapture and repositioning, and reduce peridevice leak and device-related thrombosis.

Clinical outcomes of complete versus incomplete revascularization in patients treated with coronary artery bypass grafting: insights from the TiCAB trial.

Objectives: In this post hoc analysis of the Ticagrelor in coronary artery bypass grafting (CABG) trial, we aimed to analyse patients treated with CABG receiving either complete revascularization (CR) or incomplete revascularization (ICR) independent from random allocation to either ticagrelor or aspirin.

Methods: Of 1859 patients enrolled in the Ticagrelor in CABG trial, 1550 patients (83.4%) received CR and 309 patients (16.

Ticagrelor monotherapy versus aspirin in patients undergoing multiple arterial or single arterial coronary artery bypass grafting: insights from the TiCAB trial.

Objectives: We evaluated the effect of ticagrelor monotherapy on outcomes after multiple arterial grafting (MAG) or single arterial grafting (SAG) in coronary artery bypass grafting (CABG).

Methods: In a post hoc, non-randomized analysis of the TiCAB (Ticagrelor in CABG; ClinicalTrials.gov NCT01755520) trial, we compared event rates for ticagrelor versus aspirin in patients undergoing MAG and SAG.

Ticagrelor-based antiplatelet regimens in patients treated with coronary artery bypass grafting: a meta-analysis of randomized controlled trials.

Objectives: The optimal antiplatelet strategy in patients undergoing CABG remains unclear. This is the first meta-analysis investigating the clinical outcomes associated with ticagrelor-based antiplatelet regimens in patients receiving CABG.

Methods: Relevant scientific databases were searched for studies investigating antiplatelet regimens after CABG from inception until April 1, 2019.

Retrograde Tibioperoneal Access for Complex Infrainguinal Occlusions: Short- and Long-Term Outcomes of 554 Endovascular Interventions.

Objectives: This study sought to report short- and long-term efficacy and safety outcomes of retrograde tibioperoneal access for endovascular treatment of chronic total occlusions (CTOs).

Background: Antegrade recanalization of peripheral CTO is associated with a high failure rate and retrograde puncture of tibioperoneal arteries has been adopted to overcome this limitation.

Methods: Within a retrospective single center cohort study, data of 554 infrainguinal occlusions were acquired in which a retrograde puncture of at least 1 infrapopliteal artery became necessary.

The German CPU registry: Comparison of smokers and nonsmokers.

Background: Chest pain is a major reason for admission to an internal emergency department, and smoking is a well-known risk factor for coronary artery disease (CAD) and acute coronary syndrome (ACS). The aim of this analysis is to illustrate the differences between smokers and nonsmokers presenting to German chest pain units (CPU) in regard to patient characteristics, CAD manifestation, treatment strategy, and prognosis.

Methods: From December 2008 to March 2014, 13,902 patients who had a complete 3‑month follow-up were enrolled in the German CPU registry.

Influence of irregular heart rhythm on radiation exposure, image quality and diagnostic impact of cardiac computed tomography angiography in 4,339 patients. Data from the German Cardiac Computed Tomography Registry.

Background: Coronary computed tomography angiography (coronary CTA) provides non-invasive evaluation of the coronary arteries with high precision for the detection of significant coronary artery disease (CAD).

Aim: To investigate whether irregular heart rhythm including atrial fibrillation and premature beats during data acquisition influences (i) radiation and contrast media exposure, (ii) number of non-evaluable coronary segments and (iii) diagnostic impact of coronary CTA.

Methods: Twelve tertiary care centers with ≥64 slice CT scanners and ≥5 years of experience with cardiovascular imaging participated in this registry.

Use of Fondaparinux Off-Label or Approved Anticoagulants for Management of Heparin-Induced Thrombocytopenia.

Background: Life-threatening heparin-induced thrombocytopenia (HIT) is treated with the alternative nonheparin anticoagulants argatroban, lepirudin, or danaparoid. Frequently, the pentasaccharide fondaparinux is used off-label.

Objectives: The authors sought to investigate the safety and efficacy of the different anticoagulants for treating HIT.

Impact of cardiac comorbidities on early and 1-year outcome after percutaneous mitral valve interventions: data from the German transcatheter mitral valve interventions (TRAMI) registry.

Aims: The use of the MitraClip system has gained widespread acceptance for the treatment of patients with mitral regurgitation (MR) who are not suitable for the conventional surgery. This study sought to investigate the early and 1-year outcome after MitraClip therapy of patients with MR and cardiac comorbidities.

Methods And Results: Outcomes through 12-month follow-up of patients (n = 528) who underwent MitraClip implantation were obtained from the German transcatheter mitral valve interventions (TRAMI) registry.

Midterm Patency After Femoropopliteal Interventions: A Comparison of Standard and Interwoven Nitinol Stents and Drug-Coated Balloons in a Single-Center, Propensity Score-Matched Analysis.

Purpose: To describe and compare primary patency rates in patients undergoing endovascular femoropopliteal interventions with standard or interwoven nitinol stents or drug-coated balloons.

Methods: A cohort of 1292 patients was treated for symptomatic femoropopliteal occlusive disease classified as Rutherford category ≥ 1 at a large vascular center between June 2006 and August 2013 using either standard nitinol stents (SNS; n=432), interwoven nitinol stents (INS; n=470), or drug-coated balloons (DCB; n=390). Primary patency rates were assessed by ultrasound or angiographic readings for over 3 years of follow-up.

Unintentional overestimation of an expected antihypertensive effect in drug and device trials: mechanisms and solutions.

In clinical practice we pay close attention to choosing an appropriate intervention for patients and performing it safely. We may put less thought into how to measure the effect without bias. Clinical practice involving noisy values such as blood pressure requires intelligent processing to avoid confusing patients, but applying such discretion in clinical trials may inadvertently disrupt quantification of the benefit of the intervention, in unblinded trials.

The adverse events and hemodynamic effects of adenosine-based cardiac MRI.

Objective: We wanted to prospectively assess the adverse events and hemodynamic effects associated with an intravenous adenosine infusion in patients with suspected or known coronary artery disease and who were undergoing cardiac MRI.

Materials And Methods: One hundred and sixty-eight patients (64 ± 9 years) received adenosine (140 µg/kg/min) during cardiac MRI. Before and during the administration, the heart rate, systemic blood pressure, and oxygen saturation were monitored using a MRI-compatible system.

Effects of increasing age onto procedural parameters in pacemaker implantation: results of an obligatory external quality control program.

Aims: The aim of the study was to evaluate the effects of increasing patients' age onto procedural parameters, especially complications, during primary pacemaker implantation, evaluating the database of the Institute of Quality Assurance Hessen in the federal state of Hessen, Germany.

Methods And Results: The database of the obligatory external quality control program was evaluated retrospectively for the years 2003-2006. A total of 17 826 patients undergoing stationary primary pacemaker implantation have been registered in 72 centres.

In-vitro evaluation of coronary stents and 64-detector-row computed tomography using a newly developed model of coronary artery stenosis.

Background: Stent implantation is the predominant therapy for non-surgical myocardial revascularization in patients with coronary artery disease. However, despite substantial advances in multidetector computed tomography (MDCT) coronary imaging, a reliable detection of coronary in-stent restenosis is currently not possible.

Purpose: To examine the ability of 64-detector-row CT to detect and to grade in-stent stenosis in coronary stents using a newly developed ex-vivo vessel phantom with a realistic CT density pattern, artificial stenosis, and a thorax phantom.