Preclinical determination of the best functional position for transcatheter heart valves implanted in rapid deployment bioprostheses.

AIMS: The aim of this study was to determine the best functional position of a transcatheter heart valve (THV) implanted as a valve-in-valve (ViV) procedure in small rapid deployment valves (RDV) in an in vitro model. METHODS AND RESULTS: A 21 mm Perceval, Enable or INTUITY RDV was mounted into a pulse duplicator and a 23 mm balloon-expandable or a self-expanding THV was deployed (valve-in-valve) in two different positions. Under physiological hydrodynamic conditions, the performance of the THV was characterised by mean transvalvular pressure gradient (MPG), effective orifice area (EOA) and regurgitation volume (RV). Leaflet kinematics were assessed with high-speed video recordings, and X-ray images were acquired. All THV/RDV combinations met ISO requirements regarding hydrodynamic performance. In most cases, the higher position of the THV performed better than the lower one in terms of a lower MPG and increased EOA. Leaflet motion of the implanted THV was impaired in the lower position. In contrast, regurgitation volumes were relatively small and similar, regardless of the THV position. CONCLUSIONS: ViV implantation of a THV in a small RDV yielded satisfactory hydrodynamic results. In most cases, a high implantation position achieved lower MPG, higher EOA and a reduced risk of impaired THV leaflet function. Fluoroscopy images of the best functional ViV positions are presented as a blueprint for patient procedures.

Valve-in-valve outcome: design impact of a pre-existing bioprosthesis on the hydrodynamics of an Edwards Sapien XT valve.

Objectives: Bioprosthetic aortic heart valves are increasingly implanted in younger patients. Therefore, a strategy for potential valve failure should be developed before implanting the 'first valve'. The goal of this in vitro study was to provide insight into the effects of the design of a bioprosthesis on a valve-in-valve implanted Sapien XT valve. Methods: The hydrodynamic performance of a 23-mm Sapien XT valve implanted in Vascutek Aspire, Edwards Perimount, Medtronic Mosaic and St. Jude Medical Trifecta heart valves was investigated in a left heart simulator. In addition to the hydrodynamic results, the leaflet dynamics were analysed in high-speed video recordings of the tests. Results: All valve-in-valve combinations in this study fulfilled the minimum acceptance criteria defined by relevant approval standards (e.g. ISO 5840) but displayed significant differences in their performances. Small inner diameters of the bioprostheses were associated with increased mean pressure gradients, decreased effective orifice areas and geometric opening areas as well as with pin-wheeling and uneven leaflet motion. In addition, implantation in bioprostheses with internally mounted leaflets was associated with lower paravalvular leakage. Conclusions: The results of this study suggest that a surgical bioprosthesis with a large inner diameter and internally mounted leaflets improves the heamodynamics and potentially the durability of a valve-in-valve combination. These results should give the attending physicians critical information to consider when deciding on a bioprosthesis for younger patients.

Hydrodynamic Performance of the Medtronic CoreValve and the Edwards SAPIEN XT Transcatheter Heart Valve in Surgical Bioprostheses: An In Vitro Valve-in-Valve Model.

BACKGROUND: Valve-in-valve transcatheter aortic valve replacement (TAVR) is becoming a valuable option with promising clinical results in failed bioprosthetic heart valves. Sizing recommendations are based on size compatibility rather than on broad clinical data, in vitro measurements, or biomechanical evidence. The hemodynamic performance of transcatheter heart valves within degenerated surgical heart valves is unknown. METHODS: We evaluated the in vitro hydrodynamic performance of two commercially available transcatheter heart valves (Medtronic CoreValve [Medtronic, Minneapolis, MN] and Edwards SAPIEN XT [Edwards Lifesciences, Irvine, CA]) in two different bioprosthetic aortic valves (Edwards Perimount [Edwards Lifesciences] and St. Jude Trifecta [St. Jude Medical, St. Paul, MN]). RESULTS: Within the Edwards Perimount (23 mm) prosthesis, pressure gradients were higher for the SAPIEN XT compared with the CoreValve (11.2 ± 0.1 mm Hg versus 10.1 ± 0.1 mm Hg, p < 0.01), whereas effective orifice area (1.99 ± 0.01 cm(2) versus 1.80 ± 0.01 cm(2), p < 0.01) and total paravalvular leakage (9.0% ± 1.0% versus 5.4% ± 1.3%, p < 0.01) were increased when using the CoreValve. Similarly, measurements in the St. Jude Trifecta revealed higher transvalvular pressure gradients (13.0 ± 0.2 mm Hg versus 10.9 ± 0.3 mm Hg, p < 0.01) and lower effective orifice area for the SAPIEN XT compared with the CoreValve. However, total relative regurgitation was higher with SAPIEN XT as compared with the CoreValve in St. Jude Trifecta prostheses (11.2% ± 1.4% versus 8.3% ± 0.9%, p < 0.01). CONCLUSIONS: Both transcatheter heart valve prostheses performed well in the described valve-in-valve settings. Hydrodynamic results were in line with the International Organization for Standardization standards for all configurations. The observed differences indicate a necessity for preclinical valve-in-valve tests in addition to clinical long-term data about longevity.

Development of an algorithm to plan and simulate a new interventional procedure.

OBJECTIVES: The number of implanted biological valves for treatment of valvular heart disease is growing and a percentage of these patients will eventually undergo a transcatheter valve-in-valve (ViV) procedure. Some of these patients will represent challenging cases. The aim of this study was to develop a feasible algorithm to plan and in vitro simulate a new interventional procedure to improve patient outcome. METHODS: In addition to standard diagnostic routine, our algorithm includes 3D printing of the annulus, hydrodynamic measurements and high-speed analysis of leaflet kinematics after simulation of the procedure in different prosthesis positions as well as X-ray imaging of the most suitable valve position to create a 'blueprint' for the patient procedure. RESULTS: This algorithm was developed for a patient with a degenerated Perceval aortic sutureless prosthesis requiring a ViV procedure. Different ViV procedures were assessed in the algorithm and based on these results the best option for the patient was chosen. The actual procedure went exactly as planned with help of this algorithm. CONCLUSIONS: Here we have developed a new technically feasible algorithm simulating important aspects of a novel interventional procedure prior to the actual procedure. This algorithm can be applied to virtually all patients requiring a novel interventional procedure to help identify risks and find optimal parameters for prosthesis selection and placement in order to maximize safety for the patient.

In vitro assessment of the influence of aortic annulus ovality on the hydrodynamic performance of self-expanding transcatheter heart valve prostheses.

BACKGROUND: Although CT-studies as well as intraoperative analyses have described broad anatomic variations of the aortic annulus, which is predominantly found non-circular, commercially available transcatheter aortic heart valve prostheses are circular. In this study, we hypothesize that the in vitro hydrodynamic function of a self-expanding transcatheter heart valve (Medtronic CoreValve) assessed in an oval compartment representing the aortic annulus will differ from the conventionally used circular compartment. METHODS: Medtronic CoreValve prostheses were tested in specifically designed and fabricated silicone compartments with three degrees of defined ovalities. The measurements were performed in a left heart simulator at three different flow rates. In this setting, regurgitation flow, effective orifice area, and systolic pressure gradient across the valve were determined. In addition, high speed video recordings were taken to investigate leaflet kinematics. RESULTS: The pressure difference across the prosthesis increased with rising ovality. The effective orifice areas were only slightly impacted. The analyses of the regurgitation showed minor changes and partially lower regurgitation when switching from round to slightly oval settings, followed by strong increases for further ovalization. The high speed videos show minor central leakage and impaired leaflet apposition for strong ovalities, but no leaflet/stentframe contact in any setting. CONCLUSION: This study quantifies the influence of oval expansion of transcatheter heart valve prostheses on their hydrodynamic performance. While slight ovalities were well tolerated by a self-expanding prosthesis, more significant ovality led to worsening of prosthesis function and regurgitation.