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Structural Heart Disease Interventions: Rapid Clinical Growth and Challenges in Image Guidance

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Structural Heart Disease Interventions: Rapid Clinical Growth and Challenges in Image Guidance Investigations and research Structural heart disease interventions: rapid clinical growth and challenges in image guidance J.D. Carroll University of Colorado, Department of Medicine, Division of Cardiology, S.J. Chen Colorado, USA. M.S. Kim A.R. Hansgen A. Neubauer Philips Research, Briarcliff Manor, New York, USA. University of Colorado, Department of Medicine, Division of Cardiology, Colorado, USA. O. Wink Philips Healthcare, Bothell, Washington, USA. University of Colorado, Department of Medicine, Division of Cardiology, Colorado, USA. Structural heart disease (SHD) interventions modification of anatomical structure and represent a broad category of percutaneous function, using balloon dilatation and tissue treatments for patients with both congenital ablation, to the deployment of various plugs, heart disease (CHD) and acquired heart disease valves, clips and cinching devices (Table 1). involving structural and functional abnormalities of heart valves, cardiac chambers The current status of SHD interventions ranges and the proximal great vessels [1, 2]. In the last from well-established procedures, such as five years, there has been an explosion in the percutaneous balloon valvuloplasty for stenotic number of innovative approaches to these valve conditions, which has been incorporated catheter-based treatments, ranging from the into clinical practice guidelines as the preferred Time period of Percutaneous SHD interventions Image guidance modality F emerging into Table 1. The development of practice structural heart disease (SHD) interventions. Pre-2000 Balloon valvuloplasty Fluoroscopy Balloon septostomy Catheter ablation of SVT Last 5 years Device closure of PFO, ASD, VSD, PDA Fluoroscopy plus ICE and TEE Repair of paravalvular leaks Early mapping systems Catheter ablation of atrial fibrillation, VT Alcohol septal ablation for hypertrophic cardiomyopathy Next 5 years Mitral valve repair Fluoroscopy plus 2D and 3D TEE Aortic and pulmonic valve implantation and ICE Next generation devices for PFO and ASD Advanced mapping systems Left atrial appendage occlusion devices Fluoroscopy overlay on 3D CTA, MRA, and angio reconstructions Future Valve replacement with a variety of 3D imaging wedded to mechanical and biologic types robotic navigation Repair of all valves Advanced ICE imaging Biodegradable closure devices Myocardial regenerative therapies via intramyocardial delivery Device closure of all LV aneurysms and pseudoaneuysms Shunts for Complex CHD SVT: supra-ventricular tachycardia; PFO: patent foramen ovale; ASD: atrial septal defect; VSD: ventricular septal defect; PDA: patent ductus arteriosus; VT: ventricular tachycardia; ICE: intracardiac echocardiography; TEE: transesophageal echocardiography; CTA: computer tomographic angiography; MRA: magnetic resonance angiography; CHD: congenital heart disease. MEDICAMUNDI 52/2 2008 43 E Lesion General Specific patient groups or Table 2. The frequency of SHD. defining statistic PFO 1:4 to 1:5 of population. • 36% - 59% of young adults presenting with cryptogenic stroke have a PFO. Aortic Most common etiology is related • 6% of all people over age 90 have stenosis to aging. hemodynamically significant aortic stenosis. • In patients over age 80, operative mortality of surgical aortic valve replacement approaches 30%. Mitral Frequently accompanies heart • Affects as many as 9.3% of people age 75 regurgitation failure from all causes and surgical and older. therapy not feasible. • Of the 5 million people suffering from heart failure in the USA, 15% - 20% have moderate to severe mitral regurgitation. Atrial The vast majority of patients with • The prevalence of stroke associated with AF fibrillation AF currently require long-term full increases with age. (AF) anti-coagulation. The left atrial • AF is thought to be responsible for one-sixth appendage is the site of thrombus of all ischemic strokes in people over age 60. formation in 90% of patients with • The risk of stroke among all patients with AF non-valvular AF. is about 5% per year, which is about five to six times the risk of age-matched patients in sinus rhythm. AF: atrial fibrulation; PFO: patent foramen ovale; USA: United States of America. therapeutic approach in specific clinical situations, leading to embolism are ongoing. Should these E The volume of patients to investigative technologies still in development, clinical trials demonstrate either superiority or undergoing SHD such as percutaneous valve implantation [3]. equivalence of device therapy versus chronic interventions is rapidly While many pivotal, industry-sponsored trials anti-coagulation in preventing embolic stroke increasing. are currently enrolling patients, and will have in patients with atrial fibrillation, another major results available in the next 2 - 5 years, other expansion of patients eligible for SHD technologies remain in the very early phases of interventions will occur. Finally, catheter based concept and design development (see the treatments for valvular aortic stenosis and mitral “Future” category in Table 1). As Tables 1 and regurgitation have already shown preliminary 2 illustrate, the potential for growth in this results that will likely lead to the treatment of unique clinical area is staggering. patients who had previously been ineligible for traditional surgical valve repair or replacement. The volume of patients undergoing SHD In addition, many patients will potentially be interventions is rapidly increasing, and may even switched from open surgical to catheter-based surpass the number of many vascular treatments if comparative studies show benefit interventions performed within the next decade. with less risk. The rate of growth, however, depends heavily on the outcome of several ongoing clinical trials SHD interventions show a significant departure investigating pathological conditions that are from the inherent nature of the two prior waves very common in adult cardiology practices of new interventional treatments: percutaneous (Table 2). For example, device closure of patent coronary intervention and non-coronary vascular foramen ovale (PFO) in adults to prevent disease interventions, such as carotid stenting. embolic stroke and reduce migraine frequency Unlike these vascular therapies, where over-the- are the subject of several trials that, if positive wire technologies in the well-defined space of (i.e. demonstrate that device closure is superior small branching vascular trees are used, SHD to medical therapy), will make tens of thousands interventions frequently involve navigation in of patients immediately eligible for treatment open 3D space, defined by relatively large cardiac [4, 5]. In addition, the incidence of atrial chambers, interaction with moving targets, such fibrillation continues to increase and requires as heart valves, and deployment of devices, such lifelong anti-coagulation to prevent embolic as occluders and heart valves, that function stroke. Clinical trials investigating the ability of quite differently from traditional vascular left atrial appendage (LAA) occlusion devices scaffolds. These differences subsequently impact 44 MEDICAMUNDI 52/2 2008 to prevent thrombus formation in the left atrium procedural performance by relying heavily on 1 F Figure 1. These two panels show a model of the heart of a patient who has a secundum atrial septal defect (ASD) with a deficient aortic rim. A viewing window was created in the right atrial wall to allow examination of the defect. The right panel shows the enlarged view of the defect. This model was made from cardiac computed tomography angiography (CTA) data and the transformation into a rapid prototyping file (stl) was done by the 3D Research Lab at the University of Colorado. This model is made of the operator’s knowledge (both structural and simulators are designed to familiarize operators a semi-translucent and soft material spatial) of cardiovascular anatomy and with various aspects of catheter-based closure that mimics heart tissue. Rapid physiology, training with unique navigational (i.e. anatomy, imaging modalities, etc.). This prototyping allows interventionalists devices, incorporation of new procedural skills approach also allows for the added advantage of to create models prior to challenging and familiarity with novel image guidance enabling the early learning curve of physicians SHD interventions, as well as for technologies. to occur during simulation and not on real general training purposes [8]. patients, who could potentially be exposed to Interventional cardiologists performing SHD increased risk due to the inherent novelty of the interventions must understand anatomy to a procedures. degree similar to that of cardiac surgeons. Unlike surgeons, however, interventional Recently, there have been several technological cardiologists do not have the advantage of advances in imaging modalities used in both learning cardiovascular anatomy in the setting the evaluation and treatment of SHD [7]. E Recent technological of direct anatomic exposure during open-heart Ultrasound guidance has increasingly been advances in imaging surgery. Interventionalists instead rely heavily used in SHD interventions. The emergence of SHD include ICE, TTE on medical images produced by ultrasound, percutaneous closure of atrial septal defect and TEE. computed tomography angiography (CTA), and (ASD), PFO and ventricular septal defect magnetic resonance angiography (MRA), which (VSD) marked the routine incorporation of can be processed into 3D formats and are ultrasound imaging.
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