Structural Heart Interventions Research Articles

Patient-Specific Modeling for Structural Heart Intervention: Role of 3D Printing Today and Tomorrow CME.

Structural heart interventions (SHIs) are increasingly applicable in a wide range of heart defects, but the intricate and dynamic nature of cardiac structures can make SHIs challenging to perform. Three-dimensional (3D) printed modeling integrates advanced clinical imaging and 3D printing technology to replicate patient-specific anatomy for comprehensive planning and simulation of SHIs. This review discusses the basic principles of patient-specific 3D print model development, print material selection, and model fabrication and highlights how cardiovascular 3D printing can be used in preprocedural planning, device sizing, enhanced communication, and procedure simulation.

Intracardiac echocardiography guiding structural heart disease interventions

The impressive advances in structural heart disease interventions in the last decade led to renewed interest in intracardiac echocardiography (ICE). The potential of ICE to avoid transesophageal echocardiography with its known limits, has supported ICE technology progress and wider clinical use. This review summarizes relevant evidence about ICE and provides the structural interventionalist with an illustrative guide on the use of ICE to guide various structural heart interventions.

Fusion imaging in structural heart interventions

The echocardiographic-fluoroscopic fusion imaging tool is able to acquire imaging data from both fluoroscopy and transesophageal images and co-register and align them in the three-dimensional space and time by putting onto the same coordinate system. In this way the soft tissues that are well visualized by echocardiography and the metallic materials (catheters and devices), better imaged by fluoroscopy, are displayed in the standard fluoroscopic projections in a hybrid image in real time. In this review, we describe the basic technical aspects and its main applications in transcatheter structural heart interventions.

COMPARATIVE RADIATION EXPOSURE TO INTERVENTIONAL ECHOCARDIOGRAPHERS DURING PERCUTANEOUS MITRAL VALVE REPAIR AND LEFT ATRIAL APPENDAGE CLOSURE

Interventional echocardiographers are at risk for considerable radiation exposure while performing transesophageal echocardiography during structural heart interventions. The risk posed by different types of structural heart interventions to interventional echocardiographers remains unknown. This

Antithrombotic Therapy for Percutaneous Cardiovascular Interventions: From Coronary Artery Disease to Structural Heart Interventions.

Percutaneous cardiovascular interventions have changed dramatically in recent years, and the impetus given by the rapid implementation of novel techniques and devices have been mirrored by a refinement of antithrombotic strategies for secondary prevention, which have been supported by a significant burden of evidence from clinical studies. In the current manuscript, we aim to provide a comprehensive, yet pragmatic, revision of the current available evidence regarding antithrombotic strategies in the domain of percutaneous cardiovascular interventions. We revise the evidence regarding antithrombotic therapy for secondary prevention in coronary artery disease and stent implantation, the complex interrelation between antiplatelet and anticoagulant therapy in patients undergoing percutaneous coronary intervention with concomitant atrial fibrillation, and finally focus on the novel developments in the secondary prevention after structural heart disease intervention. A special focus on treatment individualization is included to emphasize risk and benefits of each therapeutic strategy.

Temporal trends, outcomes, and predictors of mortality after pericardiocentesis in the United States.

Data regarding the temporal trends, outcomes, and predictors of in-hospital mortality after pericardiocentesis are limited. The National Inpatient Sample database was used to extract hospitalizations of patients who underwent pericardiocentesis from January 2007 to September 2015. We examined the rates of in-hospital mortality, its predictors, and the temporal trends of pericardiocentesis utilization in the United States during the study period. We also examined trends and outcomes of pericardiocentesis associated with different cardiovascular procedures. A total of 96,377 hospitalizations with pericardiocentesis were examined. The number of pericardiocentesis procedures performed trended up significantly between 2007 and 2015 (p trend <.001), and this increase was observed predominantly in patients with unstable conditions. In-hospital mortality after pericardiocentesis decreased over time (14.6% in 2007 vs. 12.0% in 2015, p trend <.001), but remained higher than that after surgical pericardial intervention (13.1 vs. 8.9%, p value <.0001), predominantly attributable to a higher patient risk profile. Rates of in-hospital mortality were not statistically different between the procedural cohort and the nonprocedural cohort, 13.5 versus 13.0%, p value = .051. After multivariable adjustment, structural heart interventions (odds ratio [OR] 2.86; 95% confidence interval [CI] 2.35-3.49), bacterial and/or infective endocarditis (OR 2.09; 95% CI 1.72-2.54) and active neoplasms (OR 1.72; 95% CI 1.6-1.85) were independently associated with increased in-hospital mortality in pericardiocentesis patients. In this nationwide analysis, the number of pericardiocentesis procedures increased significantly over time. Structural interventions, endocarditis, and active neoplasms were associated with increased in-hospital mortality after pericardiocentesis.

Three-Dimensional Printing Applications in Percutaneous Structural Heart Interventions

Cardiovascular 3-dimensional printing refers to the fabrication of patients' specific cardiac anatomic replicas based on volumetric imaging data sets obtained by echocardiography, computed tomography, or magnetic resonance imaging. It enables advanced visualization and enhanced anatomic and sometimes hemodynamic understanding and also improves procedural planning and allows interventional simulation. Also, it is helpful in communication with patients and trainees. These key advantages have led to its broad use in the field of cardiology ranging from congenital to vascular and valvular disease, particularly in structural heart interventions, where many emerging technologies are being developed and tested. This review summarizes the process of 3-dimensional printing and the workflow from imaging acquisition to model generation and discusses the cardiac applications of 3-dimensional printing focusing on its use in percutaneous structural interventions, where procedural planning now commonly relies on 3-dimensional printed models.

Three-dimensional printing in structural heart disease and intervention.

Three-dimensional (3D) printing refers to the process by which physical objects are built by depositing materials in layers based on a specific digital design. It was initially used in manufacture industry. Inspired by the technology, clinicians have recently attempted to integrate 3D printing into medical applications. One of the medical specialties that has recently made such attempt is cardiology, especially in the field of structural heart disease (SHD). SHD refers to a group of non-coronary cardiovascular disorders and related interventions. Obvious examples are aortic stenosis, mitral regurgitation, atrial septal defect, and known or potential left atrial appendage (LAA) clots. In the last decade, cardiologists have witnessed a dramatic increase in the types and complexity of catheter-based interventions for SHD. Current imaging modalities have important limitations in accurate delineation of cardiac anatomies necessary for SHD interventions. Application of 3D printing in SHD interventional planning enables tangible appreciation of cardiac anatomy and allows in vitro interventional device testing. 3D printing is used in diagnostic workup, guidance of treatment strategies, and procedural simulation, facilitating hemodynamic research, enhancing interventional training, and promoting patient-clinician communication. In this review, we attempt to define the concept, technique, and work flow of 3D printing in SHD and its interventions, highlighting the reported clinical benefits and unsolved issues, as well as exploring future developments in this field.

P996Early experience of transnasal micro-transesophageal echocardiography to guide left atrium appendage closure under conscious sedation

Abstract Introduction Percutaneous left atrial appendage closure (LAAC) is typically performed utilizing transesophageal echocardiography (TEE) and fluoroscopy under general anesthesia (GA) or intracardiac echocardiography (ICE) under conscious sedation. Transnasal microtransesophageal echocardiography (micro-TEE) is a recently described technique to guide structural heart interventions eliminating the need for GA, which is beneficial for all, especially older patients. In this series, we report our initial experience with this novel technique to guide LAAC. Methods and results Between June 2018 and January 2019, we performed 30 consecutives LAAC (mean age 80,2 years old) with the Amplatzer AMULET in whom we considered using transnasal micro-TEE under conscious sedation instead of TEE under GA. All patients had a CT prior to the procedure to assess anatomy suitability and to rule out thrombus as well as a follow-up CT performed at 3 months post-LAAC to confirm complete sealing. Three patients had TEE instead of micro-TEE for various reasons (patient preference, cognitive impairment, INR &gt;2). We observed one cross-over to TEE+GA because of a failed esophageal intubation under conscious sedation. Device implantation success rate was 100%. Imaging quality was quoted either good or excellent in 25 of the 26 patients with the remaining being quoted as suboptimal. Patient tolerance was either good or excellent in 24 of the 26 cases. There were five epistaxis noticed, one requiring nasal packing. No device embolization, no significant peri-device leak, no tamponade occurred in any patient during this period. At 3 months, there was no prosthesis thrombosis observed and 23% (6/26) had partial opacification of the LAA behind the prosthesis. Conclusion In this series, transnasal micro-TEE was feasible, safe, well tolerated and provided sufficient imaging quality to guide LAAC with the Amplatzer AMULET under conscious sedation. The cheaper cost and the wider field of view of micro-TEE over ICE are potential advantages that could impact the organization of LAAC programs especially when these interventions are planned in the elderly in whom GA carries a significant risk.

Performance of the TRUE dilatation balloon valvuloplasty catheter beyond rated burst pressure: A bench study.

We undertook an independent bench test assessing the performance of the TRUE dilatation (TD) balloon valvuloplasty catheter (Bard Vascular Inc., Tempe, AZ) beyond its rated burst pressure (RBP). The TD balloon has a RBP of six atmospheres (atm), and its performance beyond this RBP is poorly understood. Techniques such as bioprosthetic valve fracture require inflation pressures beyond manufacturer recommendations. A 20, 22, 24, 26, and 28 mm TD balloon were inflated to increasing pressures in increments of 3 atm until balloon failure. Measurements were performed at the proximal, middle, and distal balloon segments with scientific digital calipers. Z-MED balloons (Braun Interventional Systems Inc., Bethlehem, PA) were used as a comparator. The mean diameter at the middle of the 20, 22, 24, 26, and 28 mm TD balloon at nominal pressure (3 atm) was 20.02 ± 0.09, 21.77 ± 0.07, 23.9 ± 0.06, 25.82 ± 0.08, and 27.62 ± 0.08 mm, respectively. The maximal mean diameter at the middle of the 20, 22, 24, 26, and 28 mm TD balloon was 20.39 ± 0.03 mm (15 atm), 22.35 ± 0.03 mm (15 atm), 24.55 ± 0.02 mm (15 atm), 26.48 ± 0.02 mm (12 atm), and 28.39 ± 0.03 mm (12 atm), respectively. The 20/22/24 and 26/28 mm balloon failed when inflated beyond 15 atm and 12 atm, respectively. Failure was due to either leakage or longitudinal balloon rupture. TD balloons were more likely to maintain dimensions similar to their labeled size and less likely to fail at higher pressures as compared to Z-MED balloons. The TD balloon catheter maintains a similar diameter to its labeled size, when inflated beyond its RBP. When inflated beyond 12 atm, the TD balloon can fail due to either leakage or rupture. This has implications for percutaneous structural heart interventions.

TCT-367 Large-Bore Vascular Access Training With the CardioSkills Smart Puncture Simulator: A Training Tool and Concept to Avoid Vascular Access Site Complications

The use of simulators in cardiology and vascular surgery has become popular. The use of large-bore endovascular sheaths is mandatory in many structural heart and aortic interventions and is associated with a higher complication rate compared with the use of smaller sheaths in other procedures. There

The initial U.S. experience with the Tempo active fixation temporary pacing lead in structural heart interventions.

This multicenter retrospective study of the initial U.S. experience evaluated the safety and efficacy of temporary cardiac pacing with the Tempo® Temporary Pacing Lead. Despite increasing use of temporary cardiac pacing with the rapid growth of structural heart procedures, temporary pacing leads have not significantly improved. The Tempo lead is a new temporary pacing lead with a soft tip intended to minimize the risk of perforation and a novel active fixation mechanism designed to enhance lead stability. Data from 269 consecutive structural heart procedures were collected. Outcomes included device safety (absence of clinically significant cardiac perforation, new pericardial effusion, or sustained ventricular arrhythmia) and efficacy (clinically acceptable pacing thresholds with successful pace capture throughout the index procedure). Postprocedure practices and sustained lead performance were also analyzed. The Tempo lead was successfully positioned in the right ventricle and achieved pacing in 264 of 269 patients (98.1%). Two patients (0.8%) experienced loss of pace capture. Procedural mean pace capture threshold (PCT) was 0.7 ± 0.8 mA. There were no clinically significant perforations, pericardial effusions, or sustained device-related arrhythmias. The Tempo lead was left in place postprocedure in 189 patients (71.6%) for mean duration of 43.3 ± 0.7 hr (range 2.5-221.3 hr) with final PCT of 0.84 ± 1.04 mA (n = 80). Of these patients, 84.1% mobilized out of bed with no lead dislodgment. The Tempo lead is safe and effective for temporary cardiac pacing for structural heart procedures, provides stable peri and postprocedural pacing and allows mobilization of patients who require temporary pacing leads.

Thrombogenicity and Antithrombotic Strategies in Structural Heart Interventions and Nonaortic Cardiac Device Therapy-Current Evidence and Practice.

As the number of, and the indications for, structural heart interventions are increasing worldwide, the optimal secondary prevention to reduce device thrombosis is becoming more important. To date, most of the recommendations are empiric. The current review discusses mechanisms behind device-related thrombosis, the available evidence with regard to antithrombotic regimen after cardiac device implantation, as well as providing an algorithm for identification of risk factors for device thrombogenicity and for management of device thrombosis after implantation of patent foramen ovale and left atrial appendage occluders, MitraClips/transcatheter mitral valve replacement, pacemaker leads, and left ventricular assist devices. Of note, the topic of antithrombotic therapy and thrombogenicity of prostheses in aortic position (transcatheter aortic valve replacement, surgical, mechanical, and bioprostheses) is not part of the present article and is discussed in detail in other contemporary focused articles.

Returning to Fellowship for Formal Structural Heart Training After Being in Clinical Practice: Challenges and Advantages

Returning to Fellowship for Formal Structural Heart Training After Being in Clinical Practice: Challenges and Advantages

Inpatient mortality and its predictors after pericardiocentesis: An analysis from the Nationwide Inpatient Sample 2009-2013.

National registries have provided data on in-hospital outcomes for several cardiac procedures. The available data on in-hospital outcomes and its predictors after pericardiocentesis are mostly derived from single center studies. Furthermore, the outcomes after pericardiocentesis for iatrogenic pericardial effusion and the impact of procedural volume on in-hospital outcomes in the United States are largely unknown. We used national inpatient database files for the years 2009-2013 to estimate the inpatient outcomes after pericardiocentesis in all-comers and in the subgroups with iatrogenic effusion. We also studied the impact of hospital procedural volume, among other predictors, on inpatient mortality. About 64,070 (95%CI 61 008-67 051) pericardiocentesis were performed in the United States during 2009-2013. Of these, 57.15% (56.02-58.26%) of the pericardiocentesis were in hemodynamically unstable patients. Percutaneous cardiac procedures were performed in 17.7% of patients (percutaneous coronary intervention (PCI) 4.02%, electrophysiologic procedures 13.58%, and structural heart intervention (SHI) 0.76%). Overall inpatient mortality was 12.30% (95%CI 11.66-12.96%). Inpatient mortality after PCI, electrophysiologic procedures, SHI and cardiac surgery were 27.67% (95%CI 24-31.67%), 7.8% (95%CI 6.67-9.31%), 22.36% (95%CI 15.06-31.85%) and 18.97% (95%CI 15.84-22.57%), respectively. There was an inverse association between hospital procedural volume and inpatient mortality, with a mortality of 14.01% (12.84-15.26%) at the lowest and 10.82% (9.44-12.37%) at highest quartile hospitals by procedure volume (ptrend = 0.001). The inpatient mortality after pericardiocentesis is high, particularly when associated with PCI and SHI.

Initial clinical experience with the FlexPoint Steerable Transseptal Needle in left-sided structural heart procedures.

The purpose of this study is to describe the initial clinical experience with a steerable transseptal needle (STSN) for left-sided structural heart procedures. Targeted transseptal (TS) puncture is required for many structural heart procedures, and the use of a steerable needle has not previously been described. Consecutive patients undergoing structural heart interventions with targeted TS puncture under transesophageal echocardiographic (TEE) and fluoroscopic guidance were studied. The STSN was used in all patients with a standard commercial TS sheath. Deflection of the needle was performed "real time" to achieve localization of the TS puncture site. Twenty-seven patients underwent STSN puncture of the interatrial septum. In all cases, the needle could be deflected in vivo to achieve optimal tenting and localization of the puncture site without having to remove or reshape the needle. The needle was deflected to match a wide range of right atrial diameters (width 4.3 ± 0.9 cm and length 6.0 ± 0.9 cm in the 4-chamber view). In two patients with prior mitral valve surgery and a fibrotic septum, assisted crossing was achieved using the piercing stylet in one patient, and Bovie energy in the other. There were no procedural complications, and all patients had successful completion of the intended structural heart procedure. The STSN needle can be used to target the intended puncture location on the interatrial septum with real-time adjustable deflection without the need to remove and reshape the needle. In all cases crossing was successful and there were no complications.

Should Ultrasound Guidance Be Routinely Used for Femoral Artery Access?

ABSTRACTUltrasound-guided femoral artery access should always be utilized as it has been shown to significantly reduce vascular complications, number of arterial access attempts, accidental venipunctures, and time to access. Despite the increased adoption of transradial access, the conventional femoral artery cannulation remains the primary route for performing peripheral angiography and cardiac catheterization in the setting of high-risk interventional procedures requiring mechanical hemodynamic support. Similarly, with the expansion of structural heart interventions such as transcatheter aortic valve replacement and mitral valve interventions, femoral access has been increased especially for large-bore sheaths.

Vascular Access-Related Complications in Women: Temporal Trends, Emerging Data, and the Current State of Interventional Cardiology Practice.

Women undergoing cardiac catheterization, percutaneous coronary intervention, transcatheter aortic valve replacement, and other structural heart interventions have a significantly higher risk of vascular complications and bleeding than men, leading to significant morbidity and mortality. This review highlights the importance of recognizing female sex as a specific and independent risk factor, and focuses on mechanisms of increased risk and strategies to minimize that risk. Smaller caliber peripheral vessels, low body weight, variations in platelet reactivity, and inappropriate dosing of anticoagulant and antiplatelet agents are the currently identified mechanisms for elevated bleeding and vascular complication risk in women. Radial-preferred access, smaller caliber sheaths, imaging-guided arterial puncture, and more judicious anticoagulant dosing have led to reduced bleeding and vascular complication rates in both sexes, especially women. Obtaining proficiency in these strategies should be a priority for operators in order to improve safety and procedural outcomes in women.

Técnicas de fusión de imagen en los procedimientos intervencionistas

The field of percutaneous structural heart interventions has grown tremendously in recent years. This growth has fueled the development of new imaging protocols and technologies in parallel to help facilitate these minimally-invasive procedures. Fusion imaging is an exciting new technology that combines the strength of 2 imaging modalities and has the potential to improve procedural planning and the safety of many commonly performed transcatheter procedures. In this review we discuss the basic concepts of fusion imaging along with the relative strengths and weaknesses of static vs dynamic fusion imaging modalities. This review will focus primarily on echocardiographic-fluoroscopic fusion imaging and its application in commonly performed transcatheter structural heart procedures.

Interventional Echocardiography: Field of Advanced Imaging to Support Structural Heart Interventions

Multimodality imaging, particularly echocardiography, is paramount in planning and guiding structural heart disease interventions. Transesophageal echocardiography remains unique in its ability to provide real-time 2D and 3D imaging of valvular heart disease and anatomic cardiac defects, which directly impacts the strategy and outcome of these procedures. This review summarizes the role of transesophageal echocardiography in patients undergoing the most common structural heart disease interventions.