A multinational clinical approach to assessing the effectiveness of catheter-based ultrasound renal denervation: The RADIANCE-HTN and REQUIRE clinical study designs.

Catheter-based renal denervation is a new approach to treat hypertension via modulation of the renal sympathetic nerves. Although nonrandomized and small, open-label randomized studies resulted in significant reductions in office blood pressure 6months after renal denervation with monopolar radiofrequency catheters, the first prospective, randomized, sham-controlled study (Symplicity HTN-3) failed to meet its blood pressure efficacy end point. New clinical trials with new catheters have since been designed to address the limitations of earlier studies.

A Test in Context: Fractional Flow Reserve: Accuracy, Prognostic Implications, and Limitations.

Fractional flow reserve (FFR) is an invasive procedure used during coronary angiography to determine the functional significance of coronary stenoses. Its use is particularly helpful in intermediate or angiographically ambiguous lesions in the absence of noninvasive functional studies. Randomized clinical trials have reported improved clinical outcomes with the use of FFR to guide coronary revascularization, including a reduction in cardiac death or myocardial infarction, as well as costs, with an FFR-based strategy compared with a conventional angiography-based approach.

Duration of veno-arterial extracorporeal life support (VA ECMO) and outcome: an analysis of the Extracorporeal Life Support Organization (ELSO) registry.

Background: Veno-arterial extracorporeal membrane oxygenation (VA ECMO) is an effective rescue therapy for severe cardiorespiratory failure, but morbidity and mortality are high. We hypothesised that survival decreases with longer VA ECMO treatment. We examined the Extracorporeal Life Support Organization (ELSO) registry for a relationship between VA ECMO duration and in-hospital mortality, and covariates including indication for support.

Predictors and Long-Term Clinical Impact of Acute Stent Malapposition: An Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents (ADAPT-DES) Intravascular Ultrasound Substudy.

Background: The impact of acute stent malapposition (ASM) on long-term clinical outcomes in patients undergoing percutaneous coronary intervention is still controversial. We sought to evaluate predictors and long-term clinical outcomes of ASM.

Methods And Results: ADAPT-DES (Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents) was a prospective multicenter study of 8663 patients undergoing percutaneous coronary intervention using drug-eluting stents.

Impact of Methodologic Differences in Three-Dimensional Echocardiographic Measurements of the Aortic Annulus Compared with Computed Tomographic Angiography Before Transcatheter Aortic Valve Replacement.

Background: Three-dimensional (3D) echocardiographic (3DE) imaging is an alternative to multi-detector row computed tomography (MDCT) for aortic annular measurement before transcatheter aortic valve replacement (TAVR). A commonly used direct planimetry from a reconstructed short-axis view has not been compared with semiautomated 3DE methods. Typically accepted optimal cutoffs for percent prosthesis-area oversizing of the balloon-expandable SAPIEN or SAPIEN XT valve to native annular size are approximately 5% to 15%.

Association Between Duration of Dual Antiplatelet Therapy and Angiographic Multivessel Disease on Outcomes in Patients Treated With Newer-Generation Drug-Eluting Stents.

Background: There is general agreement that the optimal duration of dual antiplatelet therapy (DAPT) in patients treated with drug-eluting stents should be individualized. We hypothesized that the extent of coronary artery disease may affect the clinical outcomes of DAPT.

Methods And Results: We pooled patient-level data from 5 large, randomized trials comparing short-term DAPT with prolonged therapy.

Segmental comparison between a dedicated bifurcation stent and balloon angioplasty using intravascular ultrasound and three-dimensional quantitative coronary angiography: A subgroup analysis of the Tryton IDE randomized trial.

Objective: Randomized comparison between the Tryton Side Branch Stent (Tryton Medical, Durham, NC), used in combination with a main branch drug-eluting stent (DES), and side branch balloon angioplasty (SBBA, in combination with a main branch DES) using intravascular ultrasound (IVUS), and three-dimensional quantitative coronary angiography (3D-QCA).

Background: The Tryton stent has been developed to improve clinical outcomes after percutaneous coronary intervention (PCI) of bifurcation lesions.

Methods: We present the pre-specified IVUS (n = 159) and 3D-QCA (n = 190) sub-group analyses of the Tryton coronary bifurcation trial (randomizing Tryton vs.

Etiology, Frequency, and Clinical Outcomes of Myocardial Infarction After Successful Drug-Eluting Stent Implantation: Two-Year Follow-Up From the ADAPT-DES Study.

Background: The frequency, causes, and impact of myocardial infarction (MI) after successful percutaneous coronary intervention have not been well studied.

Methods And Results: The Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents (ADAPT-DES) study was a prospective, multicenter registry study of 8582 patients undergoing successful drug-eluting stent implantation at 11 centers in the United States and Germany. After excluding 128 patients with periprocedural MI, we investigated the pathogenesis, frequency, and long-term consequences of non-periprocedural MI in 8454 patients.

Outcomes of a dedicated stent in coronary bifurcations with large side branches: A subanalysis of the randomized TRYTON bifurcation study.

Objectives: To examine the benefit of the Tryton dedicated side branch (SB) stent compared with provisional stenting in the treatment of complex bifurcation lesions involving large SBs.

Background: The TRYTON Trial was designed to evaluate the utility of a dedicated SB stent to treat true bifurcation lesions involving large (≥2.5 mm by visual estimation) SBs.

Impact of anticoagulation regimen prior to revascularization in patients with non-ST-segment elevation acute coronary syndromes: The ACUITY trial.

Aim: To evaluate the impact of antithrombotic regimens during the medical phase of treatment among 13,819 patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS) treated with an early invasive strategy in the acute catheterization and urgent intervention triage strategy (ACUITY) trial.

Methods And Results: Endpoints included composite major adverse cardiac events (MACE), major bleeding, and net adverse clinical events (NACE; MACE or major bleeding). The median (interquartile range) duration of antithrombin use in the medical only treatment phase was 6.

Incidence, Predictors, and Impact of Post-Discharge Bleeding After Percutaneous Coronary Intervention.

Background: The incidence, predictors, and prognostic impact of post-discharge bleeding (PDB) after percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation are unclear.

Objectives: This study sought to characterize the determinants and consequences of PDB after PCI.

Methods: The prospective ADAPT-DES (Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents) study was used to determine the incidence and predictors of clinically relevant bleeding events occurring within 2 years after hospital discharge.

Recommendations for comprehensive intraprocedural echocardiographic imaging during TAVR.

Recent multicenter trials have shown that transcatheter aortic valve replacement is an alternative to surgery in a high risk population of patients with severe, symptomatic aortic stenosis. Echocardiography and multislice computed tomographic imaging are accepted tools in the pre-procedural imaging of the aortic valve complex and vascular access. Transesophageal echocardiography can be valuable for intraprocedural confirmation of the landing zone morphology and measurements, positioning of the valve and post-procedural evaluation of complications.

Impact of aortic annulus size on valve hemodynamics and clinical outcomes after transcatheter and surgical aortic valve replacement: insights from the PARTNER Trial.

Background: The objective was to evaluate the effects of aortic annulus size on valve hemodynamics and clinical outcomes in those patients included in the Placement of Aortic Transcatheter Valves (PARTNER) randomized controlled trial cohort A and the nonrandomized continued access cohort.

Methods And Results: Patients included the randomized controlled trial (n=574) and nonrandomized continued access (n=1358) cohorts were divided in tertiles according to aortic annulus diameter (small aortic annulus tertile, medium aortic annulus tertile, and large aortic annulus tertile [LAA], respectively) as measured by transthoracic echocardiography. Severe prosthesis-patient mismatch was defined as an effective aortic orifice area of <0.

Relation of C-reactive protein levels to instability of untreated vulnerable coronary plaques (from the PROSPECT Study).

C-reactive protein (CRP) levels predict adverse coronary events, but it is uncertain if they predict the burden or stability of vulnerable coronary plaques. In the Providing Regional Observations to Study Predictors of Events in the Coronary Tree study, 697 patients with acute coronary syndromes underwent percutaneous coronary intervention followed by 3-vessel angiography, gray-scale intravascular ultrasound (IVUS), and radiofrequency IVUS. Major adverse cardiac events (MACE) during 3 years of follow-up were adjudicated to initially treated culprit lesions or to untreated nonculprit lesions (NCLs).

Acquired hemoglobin variants and exposure to glucose-6-phosphate dehydrogenase deficient red blood cell units during exchange transfusion for sickle cell disease in a patient requiring antigen-matched blood.

Red blood cell exchange (RBCEx) is frequently used in the management of patients with sickle cell disease (SCD) and acute chest syndrome or stroke, or to maintain target hemoglobin S (HbS) levels. In these settings, RBCEx is a category I or II recommendation according to guidelines on the use of therapeutic apheresis published by the American Society for Apheresis. Matching donor red blood cells (RBCs) to recipient phenotypes (e.

Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery.

Background: Many patients with severe aortic stenosis and coexisting conditions are not candidates for surgical replacement of the aortic valve. Recently, transcatheter aortic-valve implantation (TAVI) has been suggested as a less invasive treatment for high-risk patients with aortic stenosis.

Methods: We randomly assigned patients with severe aortic stenosis, whom surgeons considered not to be suitable candidates for surgery, to standard therapy (including balloon aortic valvuloplasty) or transfemoral transcatheter implantation of a balloon-expandable bovine pericardial valve.