Transcatheter Pulmonary Valve Replacement

Show two hearts in one model.

The Challenge:  

Edwards Lifesciences contacted Pulse MDM to create a patient education and sales/marketing demonstration model for the Alterra Adaptive Prestent and the SAPIEN 3 Pulmonic Valve for transcatheter pulmonary valve replacement.  Edwards wanted patients with congenital heart disease (CHD) and pulmonary regurgitation due to a prior procedure to fix their pulmonary valve or right ventricular outflow tract (RVOT) to envision their treatment plan. 

 

Edwards Marketing team explained the following features were “must haves:”  

  1. Replicas of the Sapien Valve and the Alterra Prestent  
  2. A heart model that included the pulmonary artery with the right ventricular outflow tract  
  3. Two clinical scenarios to be depicted: pulmonary regurgitation and a right ventricle to pulmonary artery conduit. 

 

Model Design:

Because we needed to show two devices and two distinct clinical scenarios, Pulse MDM designed a two-sided model. Each side showed an anterior section of the heart with strategic areas cut away to see the device placement inside. We planned to make the heart with a simplified palette of a single translucent red color to place visual emphasis on the Edwards devices.  

 

Model Development:

During development, we learned that some patients with congenital heart disease (CHD) have pulmonary regurgitation due to a prior procedure to repair their pulmonary valve (right ventricular outflow tract). Typically, the prior procedure replaces a diseased pulmonary artery with a conduit or graft to restore blood flow to the lungs. The conduits or grafts can be placed for a variety of heart defects, including tetralogy of fallot, pulmonary atresia, or pulmonary stenosis. Our client elected to show the Sapien Pulmonary Valve within one of these conduits on one side of the model. The Alterra Prestent would be depicted within an enlarged pulmonary artery to create a landing zone for the Sapien Valve on the other side. 

 

During development, the client requested to exclude the catheter. Medical device professionals tend to focus on the implanted devices and the improved quality of life for a patient, versus the procedure for patient education. The procedure and instrument information are reserved for sales rep kits and training models for clinician education.   

 

Our team took great care to replicate the valve and prestent. Using real implantable valves and presents is cost prohibitive.  The Edwards SAPIEN 3 Transcatheter Heart Valve comprises three main components: three leaflets made from bovine heart tissue, a nitinol frame, and a fabric skirt. The nitinol frames were replicated with injection molded plastic. The bovine heart leaflets and skirt were replicated with a pliable thermoplastic elastomer. Although Pulse MDM planned for translucent red hearts, the client requested they be painted to add more realism. In the end, we think this decision brought the model to life. We welcome our client’s suggestions in the model-making process. Collaboration always helps to bring the model alive and make it more relatable to the clinicians. 

 

Model Solution:  

This patient education model is one of our favorites. Not only is it beautiful and brilliantly executed, but it conveys our client’s story seamlessly. The model heart provides context for the device, while the replicas allow the patient to understand how the device will be permanently implanted in their body. As a result of the model, patients understand the less invasive option of Transcatheter Pulmonary Valve Replacement TPVR with the Edwards SAPIEN 3 valve and Alterra Adaptive Prestent system. They see its function and long-term effectiveness – fewer repeat surgeries, as well as a much shorter recovery time than open heart surgery. 

 

Additionally, patients can see both clinical scenarios: the ALTERRA and SAPIEN: The model demo shows how the Alterra Adaptive Prestent makes the right ventricular outflow tract RVOT suitable for implanting the Edwards SAPIEN 3 Transcatheter Heart Valve. The patient can see that the Alterra Adaptive Prestent works as a landing zone for the Edwards SAPIEN 3 Pulmonary Valve within the RVOT. The prestent frame is implanted in the model heart and shows inflow and outflow ends.  

On the conduit side, the patient can see the SAPIEN 3 seated directly within the conduit. They can see how the Edwards SAPIEN 3 Valve is designed to work like a healthy pulmonary heart valve and help make the valve and heart work as it is intended.  

 

Procedure Overview: 

Pulmonary Valve Regurgitation 

 
Pulmonary valve regurgitation, a condition where the pulmonary valve fails to close properly, leading to backflow of blood into the right ventricle, poses significant challenges to cardiovascular health. This dysfunction can arise from various causes, including congenital defects, infective endocarditis, or complications from cardiac surgery. As the valve’s function deteriorates, symptoms such as shortness of breath, fatigue, and palpitations may manifest, impacting daily activities and quality of life. Long-term consequences may include right ventricular enlargement and eventual heart failure if left untreated. Timely diagnosis through echocardiography and appropriate management strategies, ranging from medication to surgical intervention, is crucial in mitigating its progression and improving patient outcomes. 

  

Although this custom model is not available for sale to the public, we are delighted to make you a version that is specific to your unique medical device and procedure. Please use this link to start the process of receiving a model concept; a visual representation of how clinicians and patients will experience your product and procedure. Pulse MDM does not charge for model concepts or the conversations around them so there is no risk to see how we can help you to tell your story in the most engaging and memorable way possible.