Abstract:Transcatheter aortic valve replacement (TAVR) is an over-the-wire procedure for treatment of severe aortic stenosis (AS). TAVR valves are conventionally tested using simplified left heart simulators (LHS). While those provide baseline performance reliably, their aortic root geometries are far from the anatomical in situ configuration, often overestimating the valves' performance. We report on a novel benchtop patient-specific arterial replicator designed for testing TAVR and training interventional cardiologis… Show more
“…This is necessary for predicting more realistically the performance of the valve by taking into account the anatomical variability of CAVD patients, as well as the effect of the diseased native valve leaflets with embedded calcifications, which are essentially absent in the ISO-compliant PDs. 30 Endoscopic video from the Replicator is available (Online Video 2). Figure 5 depicts the valves deployed in the patient-specific CAVD valve model before it was mounted inside the matching aorta in the Replicator system for testing.…”
Section: Resultsmentioning
confidence: 99%
“…5a), and importantly may also affect the leaflet kinematics of the under-expanded valve. 30 The differences in performance per valve when comparing the Vivitro to the Replicator are as follows: the SAVR valve had the least drop in terms of EOA and transvalvular pressure drop, with average decline of 0.22 cm 2 and 7.92 mmHg, respectively. These values in the Replicator are consistent with previously reported clinical measurements, 16,29 and demonstrate again the importance of testing prosthetic heart valves in challenging anatomical replica as complementary to baseline hydrodynamic testing.…”
Section: Discussionmentioning
confidence: 99%
“…While ISO-compliant pulse duplicators (PD) provide baseline hydrodynamic performance of prosthetic valves, it tends to overestimate TAVR valve performance due to the simplified anatomical modeling of the aortic annulus and aorta, 30 and has been shown to have a significant effect on turbulence as well as on the sinus flow. 13,14 We therefore complemented the hydrodynamic assessment by testing the valves under more realistic deployed TAVR conditions in a patient-specific anatomical model of an AS patient with an advanced stage CAVD, using the Replicator pulse duplicator system (Vascular Simulations LLC, Stony Brook, NY, USA).…”
Section: Methodsmentioning
confidence: 99%
“…13,14 We therefore complemented the hydrodynamic assessment by testing the valves under more realistic deployed TAVR conditions in a patient-specific anatomical model of an AS patient with an advanced stage CAVD, using the Replicator pulse duplicator system (Vascular Simulations LLC, Stony Brook, NY, USA). 30 Importantly, the setup and testing conditions performed in this section were also compliant with ISO guidelines. CT scans of the patient were provided anonymously by Stony Brook University Hospital after obtaining approval from the institutional review board.…”
Section: Methodsmentioning
confidence: 99%
“…3D printing and molding of the aortic arch model was performed as previously described. 30 Several calcified aortic valve replicas were manufactured. Each of the test valves was then deployed in them: the 20-mm Polynova valves ( n = 3) with the nitinol stent were deployed manually, while the 20-mm Inovare valves ( n = 2) were balloon inflated to 3.5 atm according to the manufacturer guidelines.…”
Transcatheter aortic valve replacement (TAVR) is a minimally-invasive approach for treating severe aortic stenosis. All clinically-used TAVR valves to date utilize chemically-fixed xenograft as the leaflet material. Inherent limitation of the tissue (e.g., calcific degeneration) motivates the search for alternative leaflet material. Here we introduce a novel polymeric TAVR valve that was designed to address the limitations of tissue-valves. In this study, we experimentally evaluated the hemodynamic performance of the valve and compared its performance to clinically-used valves: a gold standard surgical tissue valve, and a TAVR valve. Our comparative testing protocols included: (i) baseline hydrodynamics (ISO:5840-3), (ii) complementary patient-specific hydrodynamics in a dedicated system, and (iii) thrombogenicity. The patient-specific testing system facilitated comparing TAVR valves performance under more realistic conditions. Baseline hydrodynamics results at CO 4-7 L/min showed superior effective orifice area (EOA) for the polymer valve, most-notably as compared to the reference TAVR valve. Regurgitation fraction was higher in the polymeric valve, but within the ISO minimum requirements. Thrombogenicity trends followed the EOA results with the polymeric valve being the least thrombogenic, and clinical TAVR being the most. Hemodynamic-wise, the results strongly indicate that our polymeric TAVR valve can outperform tissue valves.
“…This is necessary for predicting more realistically the performance of the valve by taking into account the anatomical variability of CAVD patients, as well as the effect of the diseased native valve leaflets with embedded calcifications, which are essentially absent in the ISO-compliant PDs. 30 Endoscopic video from the Replicator is available (Online Video 2). Figure 5 depicts the valves deployed in the patient-specific CAVD valve model before it was mounted inside the matching aorta in the Replicator system for testing.…”
Section: Resultsmentioning
confidence: 99%
“…5a), and importantly may also affect the leaflet kinematics of the under-expanded valve. 30 The differences in performance per valve when comparing the Vivitro to the Replicator are as follows: the SAVR valve had the least drop in terms of EOA and transvalvular pressure drop, with average decline of 0.22 cm 2 and 7.92 mmHg, respectively. These values in the Replicator are consistent with previously reported clinical measurements, 16,29 and demonstrate again the importance of testing prosthetic heart valves in challenging anatomical replica as complementary to baseline hydrodynamic testing.…”
Section: Discussionmentioning
confidence: 99%
“…While ISO-compliant pulse duplicators (PD) provide baseline hydrodynamic performance of prosthetic valves, it tends to overestimate TAVR valve performance due to the simplified anatomical modeling of the aortic annulus and aorta, 30 and has been shown to have a significant effect on turbulence as well as on the sinus flow. 13,14 We therefore complemented the hydrodynamic assessment by testing the valves under more realistic deployed TAVR conditions in a patient-specific anatomical model of an AS patient with an advanced stage CAVD, using the Replicator pulse duplicator system (Vascular Simulations LLC, Stony Brook, NY, USA).…”
Section: Methodsmentioning
confidence: 99%
“…13,14 We therefore complemented the hydrodynamic assessment by testing the valves under more realistic deployed TAVR conditions in a patient-specific anatomical model of an AS patient with an advanced stage CAVD, using the Replicator pulse duplicator system (Vascular Simulations LLC, Stony Brook, NY, USA). 30 Importantly, the setup and testing conditions performed in this section were also compliant with ISO guidelines. CT scans of the patient were provided anonymously by Stony Brook University Hospital after obtaining approval from the institutional review board.…”
Section: Methodsmentioning
confidence: 99%
“…3D printing and molding of the aortic arch model was performed as previously described. 30 Several calcified aortic valve replicas were manufactured. Each of the test valves was then deployed in them: the 20-mm Polynova valves ( n = 3) with the nitinol stent were deployed manually, while the 20-mm Inovare valves ( n = 2) were balloon inflated to 3.5 atm according to the manufacturer guidelines.…”
Transcatheter aortic valve replacement (TAVR) is a minimally-invasive approach for treating severe aortic stenosis. All clinically-used TAVR valves to date utilize chemically-fixed xenograft as the leaflet material. Inherent limitation of the tissue (e.g., calcific degeneration) motivates the search for alternative leaflet material. Here we introduce a novel polymeric TAVR valve that was designed to address the limitations of tissue-valves. In this study, we experimentally evaluated the hemodynamic performance of the valve and compared its performance to clinically-used valves: a gold standard surgical tissue valve, and a TAVR valve. Our comparative testing protocols included: (i) baseline hydrodynamics (ISO:5840-3), (ii) complementary patient-specific hydrodynamics in a dedicated system, and (iii) thrombogenicity. The patient-specific testing system facilitated comparing TAVR valves performance under more realistic conditions. Baseline hydrodynamics results at CO 4-7 L/min showed superior effective orifice area (EOA) for the polymer valve, most-notably as compared to the reference TAVR valve. Regurgitation fraction was higher in the polymeric valve, but within the ISO minimum requirements. Thrombogenicity trends followed the EOA results with the polymeric valve being the least thrombogenic, and clinical TAVR being the most. Hemodynamic-wise, the results strongly indicate that our polymeric TAVR valve can outperform tissue valves.
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