This complication is an extremely important indicator in how well the patient will do long term with their new valve, explains Zhen Qian, chief of Cardiovascular Imaging Research at Piedmont Heart Institute (part of Piedmont Healthcare). "The idea was, now that we can make a patient-specific model with this tissue-mimicking 3D printing technology, we can test how the prosthetic valves interact with the 3-D printed models to learn whether we can predict leakage."
Reliable predictions
The researchers found that the models, created from CT scans of the patients' hearts, behaved so similarly to the real ones that they could reliably predict the leakage. Chuck Zhang, a professor in the Stewart School of Industrial and Systems Engineering at Georgia Tech, believes these 3-D printed valves have the potential to make a huge impact on patient care going forward
Tens of thousands of patients each year are diagnosed with heart valve disease. TAVR is often considered for patients who are at high risk for complications with an open-heart surgery to replace the valve. But the prosthetic valves are made in a variety of sizes from multiple manufacturers. Leakage occurs when the new valve doesn't achieve a precise fit and blood flows around the prosthetic rather than through it as intended.
Tens of thousands of patients each year are diagnosed with heart valve disease. TAVR is often considered for patients who are at high risk for complications with an open-heart surgery to replace the valve. But the prosthetic valves are made in a variety of sizes from multiple manufacturers. Leakage occurs when the new valve doesn't achieve a precise fit and blood flows around the prosthetic rather than through it as intended.
Reduced chance of leakage
Reducing the chances for leakage is key to patient outcome for the procedure and 3D-printing can help out here. "In preparing to conduct a valve replacement, interventional cardiologists already weigh a variety of clinical risk predictors, but our 3-D printed model gives us a quantitative method to evaluate how well a prosthetic valve fits the patient," Qian said.
The models are created with a special metamaterial design and then made by a multi-material 3-D printer, which gives the researchers control over such design parameters as diameter and curving wavelength of the metamaterial used for printing, to more closely mimic physiological properties of the tissue. For example, the models can recreate conditions such as calcium deposition -- a common underlying factor of aortic stenosis -- as well as arterial wall stiffness and other unique aspects of a patient's heart.
The models are created with a special metamaterial design and then made by a multi-material 3-D printer, which gives the researchers control over such design parameters as diameter and curving wavelength of the metamaterial used for printing, to more closely mimic physiological properties of the tissue. For example, the models can recreate conditions such as calcium deposition -- a common underlying factor of aortic stenosis -- as well as arterial wall stiffness and other unique aspects of a patient's heart.
Combining materials
Previous methods of using 3D printers and a single material to create human organ models were limited to the physiological properties of the material used. The method used by the research team - creating the models using metamaterial design and multi-material 3-D printing - takes into account the mechanical behaviour of the heart valves, mimicking the natural strain-stiffening behaviour of soft tissues that comes from the interaction between elastin and collagen, two proteins found in heart valves.
That interaction was simulated by embedding wavy, stiff microstructures into the softer material during the 3D printing process. The researchers created heart valve models from medical imaging of 18 patients who had undergone a valve replacement surgery. The models were fitted with dozens of radiopaque beads to help measure the displacement of the tissue-mimicking material.
The researchers then paired those models with the same type and size prosthetic valves that interventional cardiologists had used during each patient's valve replacement procedure. Inside a warm-water testing environment controlled to maintain human body temperature, the researchers implanted the prosthetics inside the models, being careful to place the new valves in the exact location that was used during the clinical procedure for each case.
That interaction was simulated by embedding wavy, stiff microstructures into the softer material during the 3D printing process. The researchers created heart valve models from medical imaging of 18 patients who had undergone a valve replacement surgery. The models were fitted with dozens of radiopaque beads to help measure the displacement of the tissue-mimicking material.
The researchers then paired those models with the same type and size prosthetic valves that interventional cardiologists had used during each patient's valve replacement procedure. Inside a warm-water testing environment controlled to maintain human body temperature, the researchers implanted the prosthetics inside the models, being careful to place the new valves in the exact location that was used during the clinical procedure for each case.
Interacting with prosthetics
Software was used to analyse medical imaging showing the location of the radiopaque beads taken before and after the experiment to determine how the prosthetics interacted with the 3D printed models, looking for inconsistencies representing areas where the prosthetic wasn't sealed well against the wall of the valve
Those inconsistencies were assigned values that formed a "bulge index," and the researchers found that a higher bulge index was associated with patients who had experienced a higher degree of leakage after valve placement. In addition to predicting the occurrence of the leakage, the 3-D printed models were also able to replicate the location and severity of the complication during the experiments.
Those inconsistencies were assigned values that formed a "bulge index," and the researchers found that a higher bulge index was associated with patients who had experienced a higher degree of leakage after valve placement. In addition to predicting the occurrence of the leakage, the 3-D printed models were also able to replicate the location and severity of the complication during the experiments.
Improving outcome
Qian sees the results of the study as quite encouraging. "Even though this valve replacement procedure is quite mature, there are still cases where picking a different size prosthetic or different manufacturer could improve the outcome, and 3-D printing will be very helpful to determine which one."
The researchers plan to continue to optimize the metamaterial design and 3-D printing process and evaluate the use of the 3-D printed valves as a pre-surgery planning tool, testing a larger number of patient-specific models and looking for ways to further refine their analytic tools.
The researchers plan to continue to optimize the metamaterial design and 3-D printing process and evaluate the use of the 3-D printed valves as a pre-surgery planning tool, testing a larger number of patient-specific models and looking for ways to further refine their analytic tools.
