Hybrid Procedures: Adverse Events and Procedural Characteristics—Results of a Multi-institutional Registry

Introduction. Procedural cooperation between cardiac surgeon and interventional cardiologist to facilitate interventions such as device delivery or angioplasty (hybrid procedure) has become increasingly common in the management of patients with congenital heart disease. Design. Data were prospectively collected using a multicenter registry (C3PO). Between February 2007 and December 2008, seven institutions submitted data regarding 7019 cardiac catheterization procedures. Procedural data and adverse events (AEs) of 128 hybrid procedures were evaluated. Results. There was significant variability in the number of hybrid procedures per center, ranging from one to 89 with a median of eight. A total of 60% of interventional (vs. strictly diagnostic) hybrid procedures were performed by one center. The median weight was 3.7 kg (0.7–86 kg). Single-ventricle circulation was present in 60% of the procedures. Hybrid procedures included: patent ductus arteriosus (PDA) stent placement (n = 55), vascular rehabilitation (n = 25), ventricular septal defect (VSD) device closure (n = 7), valvotomy (n = 3), and diagnostic hybrid procedures (n = 38). Sixteen AEs occurred in 15/128 (12%) procedures. These included minor or trivial AEs (n = 9), moderate AEs (n = 5), major AEs (n = 1), and catastrophic AEs (n = 1). The type of AE documented included arrhythmias (n = 6), hypoxia or hypotension (n = 3), vessel or cardiac trauma (n = 2), and other events (n = 5). Of documented AEs, 9/16 (56%) were classified as not preventable, 6/16 (38%) as possibly preventable, and 1/16 (6%) as preventable. The incidence of AE related to PDA stent placement with surgical exposure (5/50, 10%) was significantly lower when compared with PDA stent placement performed percutaneously (4/5, 80%, P= .002). Conclusion. Hybrid procedures appear to have a low incidence of associated major AEs. PDA stent placement performed as a palliation of hypoplastic left heart syndrome (HLHS) or complex single/two ventricle patients may have a lower incidence of AEs if performed using a direct approach with surgical exposure rather than a percutaneous approach. Accurate definitions of these innovative procedures are required to facilitate prospective data collection.     

Impact of Direct Transcatheter Aortic Valve Replacement Without Balloon Aortic Valvuloplasty on Procedural and Clinical Outcomes: Insights From the FRANCE TAVI Registry

Objectives

This study sought to describe the current practices and compare outcomes according to the use of balloon aortic valvuloplasty (BAV) or not during transcatheter aortic valve replacement (TAVR).

Angiographic Markers of Restenosis after Drug-Eluting Stent Implantation: Surrogates for Late Clinical Outcomes?

Introduction: Although angiographic measures of restenosis, including late lumen loss, binary angiographic restenosis, and follow-up percent diameter stenosis have value in determining the efficacy of new drug - eluting stents (DES) designs, their ability to predict clinical events, including death, myocardial infarction, and target lesion revascularization (TLR) has been questioned.
Methods: We reviewed the available literature and recent DES clinical trials to determine the relationship between clinical and angiographic markers of restenosis and late clinical outcomes after stent use.
Results: Angiographic markers are useful surrogates for predicting differences in TLR between bare metal and DES. Due to the curvilinear relationship between late lumen loss and TLR and the skewedness of the late lumen loss distribution, late lumen loss as a single index has been less effective at predicting clinical differences between different DES when the absolute values of late lumen loss are low. Beyond predicting clinical restenosis, follow-up angiographic indices have been less predictive of other late clinical events, such as very late stent thrombosis or aneurysm formation.
Conclusions: Angiographic markers of restenosis may be a useful surrogate for TLR in pilot studies of patients treated with DES, but their use as a surrogate marker for all clinical events after stent placement, including death, myocardial infarction, and stent thrombosis, may be confounded by the progression of atherosclerosis at remote sites and vagaries of the distribution of late lumen loss in patients treated with DES.     

Restenosis,Stent Thrombosis,and Bleeding Complications: Navigating Between Scylla and Charybdis

The field of interventional cardiology has significantly evolved over 40 years by overcoming several challenges. The introduction of first-generation drug-eluting stents significantly reduced the rates of restenosis, but at the expense of an increase of late stent thrombosis. Prolonged antithrombotic therapy reduced rates of stent thrombosis, but at the cost of increased bleeding. Although the advent of second-generation drug-eluting stents subsequently reduced the incidence of late stent thrombosis, its permanent nature prevents full recovery of vascular structure and function with accordant risk of very late stent failure. In the present era of interventional cardiology, the tradeoff between stent thrombosis, restenosis, and bleeding presents as a particularly complex challenge. In this review, the authors highlight major contributors of late/very late stent thrombosis while targeting stent restenosis, and they discuss evolutionary advances in stent technology and antiplatelet therapy, to further improve upon the care of patients with coronary artery disease.     

Genetics,Clinical Features,and Long-Term Outcome of Noncompaction Cardiomyopathy

Background

The clinical outcomes of noncompaction cardiomyopathy (NCCM) range from asymptomatic to heart failure, arrhythmias, and sudden cardiac death. Genetics play an important role in NCCM.

Tricuspid Regurgitation: Predicting the Need for Intervention,Procedural Success,and Recurrence of Disease

Interest in tricuspid valve pathology has rapidly expanded in response to reported poor clinical outcome for functional tricuspid regurgitation and the limited indications and options for treatment. In the past few years, different transcatheter technologies have emerged as alternatives to conventional surgery to serve this untreated high-risk population. In this review, the authors explore the indications for intervention in tricuspid regurgitation according to current guidelines, the published research to support the expansion of these indications including the role of transcatheter interventions, and the risk factors for therapy failure, which may help define the appropriate patient population for treatment.     

Angiographic Markers of Restenosis after Drug‐Eluting Stent Implantation: Surrogates for Late Clinical Outcomes?

Introduction: Although angiographic measures of restenosis, including late lumen loss, binary angiographic restenosis, and follow‐up percent diameter stenosis have value in determining the efficacy of new drug‐eluting stents (DES) designs, their ability to predict clinical events, including death, myocardial infarction, and target lesion revascularization (TLR) has been questioned. Methods: We reviewed the available literature and recent DES clinical trials to determine the relationship between clinical and angiographic markers of restenosis and late clinical outcomes after stent use. Results: Angiographic markers are useful surrogates for predicting differences in TLR between bare metal and DES. Due to the curvilinear relationship between late lumen loss and TLR and the skewedness of the late lumen loss distribution, late lumen loss as a single index has been less effective at predicting clinical differences between different DES when the absolute values of late lumen loss are low. Beyond predicting clinical restenosis, follow‐up angiographic indices have been less predictive of other late clinical events, such as very late stent thrombosis or aneurysm formation. Conclusions: Angiographic markers of restenosis may be a useful surrogate for TLR in pilot studies of patients treated with DES, but their use as a surrogate marker for all clinical events after stent placement, including death, myocardial infarction, and stent thrombosis, may be confounded by the progression of atherosclerosis at remote sites and vagaries of the distribution of late lumen loss in patients treated with DES.     

Incidence,Management, and Associated Clinical Outcomes of New-Onset Atrial Fibrillation Following Transcatheter Aortic Valve Replacement: An Analysis From the STS/ACC TVT Registry

Objectives

The aim of this study was to evaluate incidence, care patterns, and clinical outcomes in patients developing new-onset atrial fibrillation (AF) following transcatheter aortic valve replacement (TAVR).

Bioresorbable Scaffold for Treatment of Coronary Artery Lesions: Intravascular Ultrasound Results From the ABSORB Japan Trial

Objectives

The aim of this study was to characterize post-procedural intravascular ultrasound (IVUS) findings in the ABSORB Japan trial, specifically stratified by the size of target coronary arteries.

The ACURATE neo Transcatheter Heart Valve: A Comprehensive Analysis of Predictors of Procedural Outcome

Objectives

The aim of this study was to perform a comprehensive analysis of factors that affect procedural outcomes of transcatheter aortic valve replacement using the ACURATE neo prosthesis (Symetis/Boston, Ecublens, Switzerland).