A handsewn pericardial valved pulmonary conduit: pulsatile flow loop in vitro and acute porcine in vivo evaluation.

OBJECTIVES: Right ventricle to pulmonary artery anatomic discontinuity is common in complex congenital heart malformations. Handsewn conduits are a practised method of repair. In a proof-of-concept study, we evaluated pulmonary valve replacement with a handsewn pericardial valved pulmonary conduit in vitro and in vivo. METHODS: A pulsatile flow-loop model (in vitro) and an acute 60-kg porcine model (in vivo) were used. With echocardiography and pressure catheters, baseline geometry and fluid dynamics were measured. The pulmonary valve was replaced with a handsewn glutaraldehyde-treated pericardial valved pulmonary conduit corresponding to a 21-mm prosthetic valve, after which geometric measurements and fluid dynamics were reassessed. RESULTS: In vitro, 15 pulmonary trunks at 4 l/min and 13 trunks at 7 l/min, and in vivo, 11 animals were investigated. The valved pulmonary conduit was straightforward to produce at the operating table and easy to suture in place. All valves were clinically sufficient in vitro and in vivo. The mean transvalvular pressure gradient in the native valve and the conduit was 8 mmHg [standard deviation (SD): 2] and 7 mmHg (SD: 2) at 4 l/min in vitro, 19 mmHg (SD: 3) and 17 mmHg (SD: 4) at 7 l/min in vitro and 3 mmHg (SD: 2) and 6 mmHg (SD: 3) in vivo. CONCLUSIONS: Our proof-of-concept demonstrates no early evidence of structural damage to the conduit, and the fluid dynamic data were acceptable. The handsewn conduit can be produced at the operating table.

Biomechanical comparison of porcine mitral leaflets with porcine small intestinal submucosa extracellular matrix.

Porcine small intestinal submucosa extracellular matrix (SIS-ECM) used for cardiac valve repair has shown conflicting clinical outcomes with respect to calcification and failure. This may be related to differences in biomechanical properties of the material compared with the host site. The aim of this study was to compare the biomechanical properties of porcine mitral valve leaflets with SIS-ECM. Fresh porcine anterior and posterior mitral leaflet samples were cut radially and circumferentially. Similarly, 2- and 4-layered SIS-ECM were cut in orthogonal directions: length and width. Samples were subjected to a uniaxial tensile test or a dynamic mechanical analysis. Results show that the load of the porcine anterior circumferential leaflet was 39.5 N (2.4-48.5 N), which was significantly higher compared with the 2-layered length SIS-ECM which was 7.5 N (7-7.9 N), and the 4- layered length SIS-ECM which was 7.5 N (7.1-8.1 N) (p < 0.001). The load of the posterior circumferential leaflet was 9.7 N (8.3-10.7 N), which is still significantly higher when compared with the two versions of SIS-ECM. The degree of anisotropy (i.e. the ratio between circumferential-radial and width-length properties) was higher for the anterior- (ratio: 19) and posterior leaflet (ratio: 6) than the 2-layered (ratio: 5.1) and 4-layered SIS-ECM (ratio: 1.9). Especially 2-layered SIS-ECM more closely resembles the posterior mitral leaflet than the anterior mitral leaflet tissue and would be more suitable as a repair material in this position. Additionally, the anisotropic properties of mitral leaflets and SIS-ECM underscore the importance of correct orientation of the implant to ensure optimal reconstruction.

Trileaflet semilunar valve reconstruction: pulsatile in vitro evaluation.

OBJECTIVES: Residual regurgitation is common after congenital surgery for right ventricular outflow tract malformation. It is accepted as there is no competent valve solution in a growing child. We investigated a new surgical technique of trileaflet semilunar valve reconstruction possessing the potential of remaining sufficient and allowing for some growth with the child. In this proof-of-concept study, our aim was to evaluate if it is achievable as a functional pulmonary valve reconstruction in vitro. METHODS: Explanted pulmonary trunks from porcine hearts were evaluated in a pulsatile flow-loop model. First, the native pulmonary trunk was investigated, after which the native leaflets were explanted. Then, trileaflet semilunar valve reconstruction was performed and investigated. All valves were initially investigated at a flow output of 4 l/min and subsequently at 7 l/min. The characterization was based on hydrodynamic pressure and echocardiographic measurements. RESULTS: Eight pulmonary trunks were evaluated. All valves are competent on colour Doppler. There is no difference in mean pulmonary systolic artery pressure gradient at 4 l/min (P = 0.32) and at 7 l/min (P = 0.20). Coaptation length is increased in the neo-valve at 4 l/min (P < 0.001, P < 0.001, P = 0.008) and at 7 l/min (P < 0.001, P = 0.006, P = 0.006). A windmill shape is observed in all neo-valves. CONCLUSIONS: Trileaflet semilunar valve reconstruction is sufficient and non-stenotic. It resulted in an increased coaptation length and a windmill shape, which is speculated to decrease with the growth of the patient, yet remains sufficient as a transitional procedure until a long-term solution is feasible. Further in vivo investigations are warranted.

Annular and subvalvular dynamics after extracellular matrix mitral tube graft implantation in pigs.

OBJECTIVES: Entire mitral valve reconstruction with an extracellular matrix tube graft is a potential candidate to overcome the current limitations of mechanical and bioprosthetic valves. However, clinical data have raised concern with respect to patch failure. The aim of our study was to evaluate the impact of extracellular matrix mitral tube graft implantation on mitral annular and subvalvular regional dynamics in pigs. METHODS: A modified tube graft design made of 2-ply extracellular matrix was used (CorMatrix®; Cardiovascular Inc., Alpharetta, GA, USA). The reconstructions were performed in an acute 80-kg porcine model (N = 8), where each pig acted as its own control. Haemodynamics were assessed with Mikro-Tip pressure catheters and mitral annular and subvalvular geometry and dynamics with sonomicrometry. RESULTS: Catheter-based peak left atrial pressure and pressure difference across the mitral and aortic valves in the reconstructions were comparable to the values seen in the native mitral valves. Also comparable were maximum mitral annular area (755 ± 100 mm2), maximum septal-lateral distance (29.7 ± 1.7 mm), maximum commissure-commissure distance (35.0 ± 3.4 mm), end-systolic annular height-to-commissural width ratio (10.2 ± 1.0%) and end-diastolic interpapillary muscle distance (27.7 ± 3.3 mm). Systolic expansion of the mitral annulus was, however, observed after reconstruction. CONCLUSIONS: The reconstructed mitral valves were fully functional without regurgitation, obstruction or stenosis. The reconstructed mitral annular and subvalvular geometry and subvalvular dynamics were found in the same range to those in the native mitral valve. A regional annular ballooning effect occurred that might predispose to patch failure. However, the greatest risk was found at the papillary muscle attachments.

Mitral Annular Forces and Their Potential Impact on Annuloplasty Ring Selection.

Objectives: To provide an overview that describes the characteristics of a mitral annuloplasty device when treating patients with a specific type of mitral regurgitation according to Carpentier's classification of mitral regurgitation. Methods: Starting with the key search term "mitral valve annuloplasty," a literature search was performed utilising PubMed, Google Scholar, and Web of Science to identify relevant studies. A systematic approach was used to assess all publications. Results: Mitral annuloplasty rings are traditionally categorised by their mechanical compliance in rigid-, semi-rigid-, and flexible rings. There is a direct correlation between remodelling capabilities and rigidity. Thus, a rigid annuloplasty ring will have the highest remodelling capability, while a flexible ring will have the lowest. Rigid- and semi-rigid rings can furthermore be divided into flat and saddled-shaped rings. Saddle-shaped rings are generally preferred over flat rings since they decrease annular and leaflet stress accumulation and provide superior leaflet coaptation. Finally, mitral annuloplasty rings can either be complete or partial. Conclusions: A downsized rigid- or semi-rigid ring is advantageous when higher remodelling capabilities are required to correct dilation of the mitral annulus, as seen in type I, type IIIa, and type IIIb mitral regurgitation. In type II mitral regurgitation, a normosized flexible ring might be sufficient and allow for a more physiological repair since there is no annular dilatation, which diminishes the need for remodelling capabilities. However, mitral annuloplasty ring selection should always be based on the specific morphology in each patient.

Mitral Valve Posterior Leaflet Reconstruction Using Extracellular Matrix: In Vitro Evaluation.

PURPOSE: To investigate the anatomical and functional effects of complete surgical reconstruction of the posterior mitral leaflet and associated chordae tendineae with a patch made of 2-ply small intestinal submucosal extracellular matrix in vitro. METHODS: Seven explanted mitral valves with intact subvalvular apparatus from 80-kg pigs were evaluated in a left heart simulator and served as their own controls. After testing the native valve, the mitral posterior leaflet and associated chordae tendineae were excised and reconstructed by using the 2-ply small intestinal submucosa extracellular matrix patch. The characterization of the reconstruction was based on geometric data from digital images, papillary muscle force, annular tethering force and leaflet pressure force. RESULTS: The reconstructed valves were fully functional without regurgitation, tearing or rupture during incrementally increased pressure from 0 to 120 mmHg. The leaflet areas were preserved after reconstruction, with a normal configuration of the coaptation line. However, the coaptation midpoint moved posteriorly after reconstruction (A2: 15.8 ± 1.4 vs. 18.9 ± 1.5 mm, p = 0.002, diff = 3.1 mm, 95% CI 1.3 to 4.8 mm). The anterior papillary muscle force increased significantly (3.9 vs. 4.6 N, p = 0.029, diff = 0.7 N, 95% CI 0.1 to 1.4 N at 120mmHg) after reconstruction. The posterior papillary muscle force, leaflet pressure force and annular pressure force did not change significantly. CONCLUSIONS: In this in vitro model, mitral valve anatomy and function were comparable between the native mitral valve and our new surgical technique for complete reconstruction of the posterior mitral leaflet and associated chordae tendineae. These promising results warrant further in vivo evaluation.

Altered stresses and dynamics after single and double annuloplasty ring for aortic valve repair.

OBJECTIVES: Aortic valve repair procedures for the treatment of isolated aortic valve insufficiency may be improved by stabilizing the functional aortic annulus using a double annuloplasty ring at the aortic annulus and sinotubular junction (STJ). The objective of this study was to compare the geometrical changes and aortic root stress distribution when using a single subvalvular ring and a double sub- and supravalvular ring in vivo. METHODS: Both the single- and double-ring procedures were performed successively in nine 80-kg pigs. Measurements were performed intraoperatively using sonomicrometry crystals in the aortic root to evaluate geometrical changes and annular and STJ force transducers measuring the segmental radial stress distribution. RESULTS: The total force in the STJ was significantly reduced after the double-ring procedure from 1.7 ± 0.6 to 0.04 ± 1.1 N (P = 0.001). The double-ring procedure significantly reduced the STJ area from 234.8 ± 37.6 to 147.5 ± 31.8 mm2 (P = 0.001) and expansibility from 17 ± 6% to 8 ± 3% (P = 0.001). With the single-ring procedure, the STJ shape was circular but became more oval with the double-ring procedure. The double-ring procedure did not affect stress distribution or geometry in the aortic annulus. CONCLUSIONS: The double-ring procedure stabilized the whole aortic root by reducing radial stress distribution in the STJ more efficiently than the single-ring procedure. Both area and expansibility were reduced with the double-ring procedure. These results confirm the importance of addressing the entire functional aortic annulus for optimal aortic valve repair procedures.

Entire mitral reconstruction with porcine extracellular matrix in an acute porcine model.

OBJECTIVE: The objective of our study was to investigate the feasibility of reconstructing the entire mitral valvular and subvalvular apparatus in pigs using a modified tube graft design made of 2-ply small intestinal submucosa extracellular matrix. METHODS: The reconstructions were performed in an acute 80-kg porcine model with 8 pigs, each acting as its own control. A modified tube graft was designed from a sheet of 2-ply small intestinal submucosa extracellular matrix. Before and after mitral valve reconstruction, echocardiography was used to assess mitral regurgitation, left ventricular outflow tract obstruction due to systolic anterior motion, mitral stenosis, leaflet mobility, and leaflet geometry. RESULTS: The reconstructed mitral valves were fully functional without any observable echocardiographic signs of regurgitation. We did not observe any left ventricular outflow tract obstruction due to systolic anterior motion nor any mitral valve stenosis, despite a diminished septal-lateral distance after reconstruction. The reconstruction had a reduced tenting area, a reduced coaptation length (9.6 ± 1.7 mm vs 7.9 ± 1.0 mm, P = .010, diff = -1.7 mm, 95% confidence interval, -3.1 to -0.4 mm), and atrial bending of both leaflets. CONCLUSIONS: In this acute porcine study, entire mitral valvular and subvalvular apparatus reconstruction using a modified tube graft design made from 2-ply small intestinal submucosal extracellular matrix was feasible. The 2-ply small intestinal submucosa extracellular matrix could withstand the pressure exerted by the left ventricle without any signs of tearing or rupture. These promising results warrant further assessment of both the annular geometry and the long-term durability.

Entire mitral valve reconstruction using porcine extracellular matrix: static in vitro evaluation.

OBJECTIVES: To investigate the feasibility of reconstruction of the entire mitral valve using a tube graft made of 2-ply small intestinal submucosa extracellular matrix in vitro. METHODS: Seven explanted mitral valves with intact subvalvular apparatus from 80 kg pigs were evaluated in a left heart simulator and served as controls. After testing the native valve, the leaflets and chordae tendineae were explanted, and the 2-ply small intestinal submucosa extracellular matrix (CorMatrix®; Cardiovascular Inc., Alpharetta, GA, USA) tube graft was implanted. The characterization was based on geometric data from digital images, papillary muscle force, annular tethering force and leaflet pressure force. RESULTS: The tube grafts were fully functional without any signs of leakage, tearing or rupture during incrementally increased pressures from 0 mmHg to 120 mmHg. The posterior leaflet moved anteriorly and became larger after reconstruction when compared with the native valve. However, the mid coaptation point was preserved. The anterior papillary muscle force decreased significantly (5.2 N vs 4.4 N, P = 0.022 at 120 mmHg), and the posterior papillary muscle force increased significantly (4.8 N vs 5.6 N, P = 0.017 at 120 mmHg) after reconstruction. CONCLUSIONS: The entire mitral valvular and subvalvular reconstruction with a 2-ply small intestinal submucosa extracellular matrix tube graft is feasible in an in vitro model. Our method of reconstruction increased the convexity of the anterior leaflet's coaptation line and significantly redistributed the papillary muscle force towards the posterior papillary muscle. These promising results and the prospect of the entire mitral valvular and subvalvular reconstruction warrant further in vivo evaluations.

Mitral valve posterior leaflet reconstruction using extracellular matrix: an acute porcine study.

OBJECTIVES: To investigate mitral valve posterior leaflet and subvalvular reconstruction using a 2-ply small intestinal submucosal extracellular matrix sheet. METHODS: Mitral valve posterior leaflet and subvalvular reconstruction was characterized in an acute 80-kg porcine model with 7 pigs acting as their own controls. The characterization was based on pressure catheter measurements of pressure differences to identify mitral regurgitation, stenosis and systolic anterior motion. Furthermore, echocardiography was used for the evaluation of leaflet mobility and geometry, whereas sonomicrometry was used to describe annular and subvalvular geometry. RESULTS: The reconstructed mitral valve was fully functional without any signs of regurgitation (peak left atrial pressure for baseline and reconstruction 12 ± 2 mmHg vs 11 ± 2 mmHg, P = 0.550), mitral valve stenosis (mean pressure difference across the mitral valve 4.8 ± 2.3 mmHg vs 4.1 ± 2.3 mmHg, P = 0.589) or systolic anterior motion. The echocardiographic characterization revealed septal-lateral downsizing, reduced tenting area, increased coaptation length (6.0 ± 0.6 mm vs 8.7 ± 2.3 mm, P = 0.002) and an atrial bend of the reconstructed posterior leaflet. A ballooning effect of the patch material was present at the posterior annular segment. CONCLUSIONS: Mitral valve posterior leaflet and subvalvular reconstruction using a 2-ply small intestinal submucosal extracellular matrix sheet as patch material was possible in an acute porcine model. The reconstructed mitral valve was fully functional without signs of mitral valve stenosis, valve regurgitation, stenosis or systolic anterior motion. The ballooning appearance of the patch material might, however, constitute an altered leaflet stress distribution in this area.