Opening/closing pattern of Trifecta and Freestyle valves versus native aortic valve: Are stentless valves more physiologic than a stented valve?

BACKGROUND: Stentless valves have long been considered the ideal valves in terms of hemodynamics. Recently, the Trifecta valve, a stented bioprosthesis with excellent fluid dynamic characteristics, has become available. The aim of the study was to compare the opening/closing pattern of the Freestyle stentless valve and the Trifecta valve with that of the native aortic valve. METHODS: A total of 12 patients with a Freestyle and 10 with a Trifecta valve were compared to normal native aortic valves in 12 control patients. Leaflet kinematics and hemodynamic parameters were obtained by echocardiographic M-mode and Doppler measurements. RESULTS: The control group displayed significantly longer Rapid Valve Opening Time (45 ± 7 ms) and Rapid Valve Closing Time (42 ± 9 ms) than Freestyle patients (Rapid Valve Opening Time: 32 ± 7 ms; Rapid Valve Closing Time: 31 ± 8 ms) and Trifecta patients (Rapid Valve Opening Time: 31 ± 7 ms; Rapid Valve Closing Time: 30 ± 8 ms) (P < 0.0001). The maximal leaflet displacement reached at the end of rapid valve opening was 16.7 ± 3.2 mm, 17.7 ± 2.3 mm, and 17.7 ± 5.3 mm (P = 0.42) in the Freestyle, Trifecta, and control groups, respectively. The total opening time was shorter in the control group (223 ± 25 ms) than in Freestyle (319 ± 61 ms) and Trifecta (324 ± 46 ms) patients (P < 0.0001). CONCLUSIONS: The Freestyle stentless valve was not superior to the Trifecta valve in terms of kinematics and functions more like a stented bioprosthesis.

Opening-closing pattern of four pericardial prostheses: results from an in vitro study of leaflet kinematics.

Pericardial and porcine stented aortic valves have different leaflet kinematics. To study the biomechanics of a prosthesis thoroughly, the in vitro setting is the most appropriate. The aim of our study was to find out whether the prosthesis design in which the pericardial sheet is outside the stent post might influence the opening and closing patterns of the leaflets. Four pericardial prostheses (Magna Ease [MG] 21, Trifecta [TRI] 21, Soprano-Armonia [SA] 20 and Mitroflow [MF] 23) that fitted aortic roots with a native annulus diameter of 2.1 cm were implanted and their leaflet kinematics was studied by a high-speed digital camera. In the opening phase, MG showed the shortest RVOT and the highest RVOVI, with values of 12 ± 2 and 209 ± 17 ms, respectively. The RVOT of MG was significantly shorter than that of MF (p < 0.01), but not than that of TRI (p = 0.286). Both TRI and SA showed similar opening patterns (TRI: RVOT of 15 ± 3 ms and RVOVI of 132 ± 25 ms; SA: 17 ± 2 ms and 126 ± 19 ms), without statistically significant difference. Conversely, MF showed the slowest profile, with an RVOT of 23 ± 3 ms and an RVOVI of 94 ± 8 ms (Table 1; Fig. 3). The opening/closing profile is not influenced by the position of the pericardial leaflets, but depends on other intrinsic structural characteristics related to the material used for the stent and leaflets. Moreover, the kinematics does not affect the valve performance. Table 1 Kinematics and hydrodynamic results, reported as means and standard deviations, evaluated over the tested heart samples TRI SA MG MF ANOVA TRI versus SA TRI versus MG TRI versus MF SA versus MG SA versus MF MG versus MF p Value p Value p Value p Value p Value p Value p Value ET (ms) 1.0 1.0 1.0 1.0 RVOT (ms) 15 ± 3 17 ± 2 12 ± 2 23 ± 3 <0.01 1.0 0.286 <0.01 0.03 <0.01 <0.01 SVCT (ms) 247 ± 14 231 ± 15 256 ± 26 241 ± 11 0.170 0.463 0.853 0.931 0.213 1.0 1.0 RVCT (ms) 35 ± 19 52 ± 13 32 ± 17 52 ± 4 0.07 0.474 1.0 0.494 0.236 1.0 0.247 TVCT (ms) 283 ± 10 283 ± 19 289 ± 10 293 ± 11 0.584 1.00 1.0 1.0 1.0 1.0 1.0 RVOVI (ms-1) 132 ± 25 126 ± 19 209 ± 17 94 ± 8 <0.01 0.959 <0.01 0.02 <0.01 0.07 <0.01 SVCVI (ms-1) -0.9 ± 0.3 -1.1 ± 0.4 -0.57 ± 0.1 -0.55 ± 0.1 <0.01 1.0 0.353 0.292 0.045 0.04 1.0 RVCVI (ms-1) -16 ± 4 -10 ± 2 -18 ± 6 -10 ± 1 <0.01 0.396 1.0 0.513 0.025 1.0 0.03 Δp (mmHg) 6.7 ± 3.6 10.6 ± 5.5 15.2 ± 7.9 10.7 ± 6.1 <0.01 0.01 <0.01 0.01 0.04 1.0 <0.01 EOA (cm2) 2.2 ± 1.2 1.7 ± 0.9 1.5 ± 0.8 1.7 ± 0.9 <0.01 0.03 <0.01 0.01 0.261 0.617 0.11 El  % 7.3 ± 1 11.9 ± 1 15.4 ± 2 11.8 ± 3 <0.01 <0.01 <0.01 <0.01 0.04 1.00 0.03 CO (L/min) 3.1 ± 0.4 2.8 ± 0.5 3.1 ± 0.3 3.0 ± 0.5 0.534 0.282 0.792 0.702 0.106 0.552 0.559 ET ejection time, RVOT rapid valve-opening time, SVCT slow valve-closing time, RVCT rapid valve-closing time, TVCT total valve-closing time, RVOVI rapid valve-opening velocity index, SVCVI slow valve-closing velocity index, RVCVI rapid valve-closing velocity index, Δp mean pressure drop, EOA effective orifice area, El % energy loss, CO cardiac output.

A Comprehensive Fluid Dynamic and Geometric Study for an "In-Vitro" Comparison of Four Surgically Implanted Pericardial Stented Valves.

BACKGROUND AND AIM OF THE STUDY: Many variables may affect the fluid dynamic of an implanted bioprosthesis. In-vitro studies have provided accurate data such that, when different prostheses are implanted in the same true aortic root, it should be possible to make a fair comparison. The study aim was to evaluate the fluid dynamic and geometric characteristics of the four most widely used stented pericardial bioprostheses. METHODS: Four types of pericardial prosthesis (Magna Ease 21, Trifecta 21, Soprano-Armonia 20, and Mitroflow 23) that fitted eight aortic roots with a native annulus diameter of 2.1 cm were implanted and tested in a mock loop. RESULTS: Energy loss and mean gradients were increased with stroke volume (SV) in all valves tested. The effective orifice area values were fairly stable across the SV intervals (p = 0.57). All hemodynamic-related indices displayed mutually consistent behaviors, with Trifecta showing the lowest hindrance to flow. Both geometric orifice area (GOA) and edge geometric orifice area (eGOA) were increased significantly as the SV increased; the Trifecta valve showed the largest eGOA value, while the Trifecta and Mitroflow provided the largest GOAs. For the Trifecta and Soprano-Armonia prostheses (and the Magna to a lesser extent), the most distal cross-section was systematically greater than the inflow area, suggesting a divergent configuration at the systolic peak. CONCLUSION: The study results combined the fluid dynamic reproducibility of the in-vitro setting and the specificity of surgery. A quantitative comparison of the fluid dynamic performance of the different bioprostheses was feasible.

Hemodynamic comparison between Trifecta and Freestyle valves implanted in small aortic roots. One-year echocardiographic results from a prospective randomized study.

BACKGROUND AND AIM OF THE STUDY: Aortic valve replacement in patients with a small aortic root may be associated to high residual gradients. In such patients, both stentless valves and aortic annulus enlargement can reduce these residual gradients. Several studies have reported that Trifecta valves yield very good hemodynamic results. The aim of the present study was to compare the hemodynamic performance of Trifecta vs. Freestyle valves at one year in patients with an aortic annulus ≤ 2.3 cm. METHODS: Between September 2011 and September 2013, 40 patients with a native aortic annulus diameter ≤ 2.3 cm and average age of 81 ± 4 years, were randomized to receive either a St-Jude Trifecta stented prosthesis (20 patients) or a Medtronic Freestyle stentless prosthesis (20 patients). RESULTS: No differences between Trifecta and Freestyle were found at one year in mean gradient s: 6.1 ± 3 mmHg and 6.6 ± 3 mmHg (p = 0.796); effective ori fice area: 1.82 ± 0.3 mmHg and 1.76 ± 0.4 mmHg (p = 0.676) or regression of left ventricular mass: - 25% ± 14 vs. -19% ± 16 (p = 0.204), respectively. Only moderate patient -pro sthesis mismatch was found, which affected 3 patient s in each group. CONCLUSION: At one year both stentless and stented prostheses yielded comparable hemodynamic results. These data suggest that Trifecta implantation is a valid means of avoiding patient -prosthesis mismatch in aortic valve replacement in elderly patients with a small native aortic annulus.

Hemodynamic comparison between Trifecta and freestyle aortic valve during exercise in patients with small aortic root.

BACKGROUND: Patients with a small aortic annulus, that is ≤ 23 mm, constitute a challenge for the surgeon, because they are at high risk of patient-prosthesis mismatch. Stentless valves provide better hemodynamic performance at rest and during exercise than stented valves, and are advocated in this group of patients. A new-generation stented valve, the Trifecta (St. Jude), has recently become available with improved hemodynamics. The aim of this study was to compare the hemodynamic performance of Freestyle (Medtronic) and Trifecta at rest and during exercise in patients with a small aortic annulus. METHODS: From September 2012 to September 2014, 22 patients with a native aortic annulus ≤ 23 mm underwent ergometric stress testing one year after aortic valve replacement with either a Trifecta (12 patients) or a Freestyle (10 patients) bioprosthesis as part of a randomized study. RESULTS: The mean gradient at rest was 6.0 ± 2.3 mmHg for Trifecta and 4.3 ± 3.5 for Freestyle (p = 0.213). The mean gradient at peak of exercise was 9.7 ± 3.4 mmHg for Trifecta and 7.4 ± 5 mmHg for Freestyle (p = 0.243). No significant differences were found between the two prostheses regarding other hemodynamic parameters: effective orifice area, velocity index, and performance indexes. CONCLUSION: Both the stented Trifecta and stentless Freestyle prostheses provide excellent hemodynamic results during physical stress in patients with a small aortic annulus. Our study confirms that Trifecta implantation results in low gradients at rest and during exercise and that the performance of Trifecta is similar to that of a stentless valve.

Early hemodynamic evaluation of Trifecta and Freestyle bioprostheses in patients with a small aortic root: preliminary results from a prospective randomized study.

BACKGROUND AND AIM OF THE STUDY: Aortic valve replacement (AVR) in patients with a small aortic root is often associated with some degree of obstruction and residual gradients. Stentless valves display better hemodynamic performance than stented valves, and might be ideal in patients with a small aortic annulus. A new stented bioprosthesis, the Trifecta valve, has recently become available and has yielded interesting early results. The study aim was to compare the hemodynamic performance of the Trifecta valve with that of the Freestyle valve in patients with an aortic annulus ≤ 2.3 cm. METHODS: Between September 2011 and September 2013, a total of 40 patients with pure aortic stenosis and native aortic annulus diameter ≤ 2.3 cm was randomized to receive either a St. Jude Medical Trifecta stented prosthesis (n = 20) or a Medtronic Freestyle stentless prosthesis (n = 20). Hemodynamics results were compared between the two groups on discharge from hospital. RESULTS: The Trifecta valve showed slightly better hemodynamics, with peak gradients of 11 ± 5 mmHg and 17 ± 9 mmHg (p = 0.009), and mean gradients of 5.5 ± 3 mmHg and 7.5 ± 4 mmHg (p = 0.06) for the Trifecta and Freestyle valves, respectively. The average indexed effective orifice area (EOAi) was 1.14 ± 0.23 cm2/m2 and 1.09 ± 0.20 cm2/m2 (p = 0.520) for the Trifecta and Freestyle, respectively. Patient-prosthesis mismatch (PPM) occurred in two patients of the Freestyle group, and in three patients of the Trifecta group. CONCLUSION: In the present study, the stentless and stented prostheses each yielded comparable and excellent early hemodynamics results. The data obtained suggest that Trifecta valve implantation is a valid means of avoiding PPM after AVR in patients with a small native aortic annulus.

Late Migration of Fully Deployed Left Main Coronary Stent into Aortic Root: A Late Complication and Its Surgical Management.

ABSTRACT: Migration and embolization of a deployed stent is a rare complication of percutaneous coronary interventions (PCI) and can result in serious and potentially life-threatening complications. There are many reports of intracoronary stent entrapment, stripping, and dislodgement during PCI, however, only a few reports about migration. We report a rare case of migration of the left main coronary stent into the aortic root, which happened 5 months after the procedure and was treated by its partial removal through aortotomy along with surgical revascularization. The patient was discharged 5 days later, after an uneventful hospital stay.

Complete heart block caused by sinus of valsalva pseudoaneurysm-A rare case.

Acquired pseudoaneurysms of the aortic root involving the sinus of Valsalva (SOV) are rare and serious complications arising from trauma, infection, or following cardiac surgery or intervention. Complete heart block (CHB) is an atypical presentation of SOV pseudoaneurysm due to either direct compression effects or involvement of the main conducting system by blood and inflammatory cell infiltration. Herein, we describe a rare case of a patient who presented with CHB caused by an SOV pseudoaneurysm following polytrauma and was treated with surgical closure of pseudoaneurysm followed by implantation of a permanent pacemaker to treat the persistent CHB.

Coronary Perfusion After Valve-in-Valve Transcatheter Aortic Valve Implantation in Small Aortic Root: In Vitro Experimental Assessment.

Coronary flow obstruction following transcatheter aortic valve-in-valve implantation (VIV-TAVI) is associated with a high mortality risk. The aim of this work was to quantify the coronary perfusion after VIV-TAVI in a high-risk aortic root anatomy. 3D printed models of small aortic root were used to simulate the implantation of a TAVI prosthesis (Portico 23) into surgical prostheses (Trifecta 19 and 21). The aortic root models were tested in a pulsatile in vitro bench setup with a coronary perfusion simulator. The tests were performed at baseline and post-VIV-TAVI procedure in aligned and misaligned commissural configurations under simulated hemodynamic rest and exercise conditions. The experimental design provided highly controllable and repeatable flow and pressure conditions. The left and right coronary mean flow did not differ significantly at pre- and post-VIV-TAVI procedure in any tested configurations. The commissural misalignment did not induce any significant alterations to the coronary flow. High-risk aortic root anatomy did not trigger coronary ostia obstruction or coronary flow alteration after transcatheter aortic valve implantation in a surgical bioprosthesis as shown from in-vitro flow loop tests.

Aortic root pseudoaneurysm after blunt trauma to chest - an interesting case.

Acquired pseudoaneurysms of the aortic root involving the sinus of Valsalva are rare and serious complications arising from trauma, infection, or following cardiac surgery or intervention. We describe the surgical treatment of a patient who had acquired sinus of Valsalva pseudoaneurysm following blunt trauma to chest; wherein pericardial patch closure of the orifice of the pseudoaneurysm without aortic valve replacement or coronary artery bypass grafting. The management of these sinus of Valsalva pseudoaneurysms depends on the underlying mechanism causing symptoms such as compression or thrombosis of coronary artery; or the defective anatomy involving sinus of Valsalva, aortic valve or the coronary artery.

In vitro four-dimensional flow magnetic resonance analysis of the effect of pericardial valve design on aortic flow.

We investigated the effect of the design of bioprosthetic pericardial valves on the downstream fluid flow pattern through four-dimensional flow magnetic resonance imaging (4D Flow). A dedicated in vitro test bench, including a paradigmatic aortic root phantom, was used to compare, under steady flow conditions, three commercially used pericardial bioprostheses (TrifectaTM, Carpentier-Edwards PERIMOUNT Magna, Crown PRT®), selecting the two smallest and comparable valve sizes. In-house 4D Flow post-processing provided the downstream flow pattern of velocity, the velocity profile at vena contracta, its effective orifice area (EOA) and the corresponding hydraulic diameter (DH). Trifecta reported the lowest peak of velocity for both the tested sizes, with vena contracta position being the most proximal to the free margin of leaflets. Conversely, in both Crown and Magna, jet flow continued to increase its downstream velocity, resulting in a farther position of vena contracta. EOA shape was trilobal for Magna, triangular for Crown and circular for Trifecta, the last one maximising EOA. The percentage of nominal luminal area effectively exploited by the flow was largely above 80% in Trifecta, below 75% in Crown and below 70% in Magna. Hence, the design of pericardial bioprostheses directly impacts on the downstream flow field pattern and its fluid dynamic performance.

Leaflet kinematics after the Yacoub and Florida-sleeve operations: results of an in vitro study.

OBJECTIVES: The Florida-sleeve is a valve-sparing technique that causes minimal interference to leaflet kinematics and aortic root dynamism. The aim of this in vitro study was to evaluate the effects of the Florida-sleeve and Yacoub techniques on aortic leaflet kinematics. METHODS: Two groups of 6 whole porcine hearts were treated with either the Florida-sleeve technique or the Yacoub technique and tested in a pulsatile loop. Valve fluid dynamics, coronary flow analysis and valve echocardiograms were performed both before and after the procedures. RESULTS: Both procedures showed no difference in rapid valve opening time as compared with their respective baseline values. The Florida-sleeve procedure showed a shorter slow closing time (192 ± 19 ms vs baseline 244 ± 14 ms, P = 0.016) and increased slow closing velocity (-1.5 ± 0.4 cm/s vs baseline -0.8 ± 0.4 cm/s, P = 0.038). In the rapid valve closing phase, the Yacoub procedure showed a trend towards slower closing valve velocity (-16 ± 9 cm/s vs baseline -25 ± 9 cm/s, P = 0.07). The Yacoub procedure showed larger leaflet displacement at the end of the slow valve closing time that was 2.0 ± 0.5 cm vs baseline 1.5 ± 0.3 cm, P = 0.044. When comparing the Florida-sleeve and Yacoub procedures, the former showed statistically significant shorter slow valve closing time (P = 0.017). CONCLUSIONS: This study showed that the Florida-sleeve technique alters the slow closing phase of the aortic valve leaflet kinematics when compared with both the normal baseline and Yacoub procedure, while the latter showed a larger leaflet displacement before the rapid closing valve phase.

Essential information on surgical heart valve characteristics for optimal valve prosthesis selection: expert consensus document from the European Association for Cardio-Thoracic Surgery (EACTS)-The Society of Thoracic Surgeons (STS)-American Association for Thoracic Surgery (AATS) Valve Labelling Task Force.

Comprehensive information on the characteristics of surgical heart valves (SHVs) is essential for optimal valve selection. Such information is also important in assessing SHV function after valve replacement. Despite the existing regulatory framework for SHV sizing and labelling, this information is challenging to obtain in a uniform manner for various SHVs. To ensure that clinicians are adequately informed, the European Association for Cardio-Thoracic Surgery (EACTS), The Society of Thoracic Surgeons (STS) and American Association for Thoracic Surgery (AATS) set up a Task Force comprised of cardiac surgeons, cardiologists, engineers, regulatory bodies, representatives of the International Organization for Standardization and major valve manufacturers. Previously, the EACTS-STS-AATS Valve Labelling Task Force identified the most important problems around SHV sizing and labelling. This Expert Consensus Document formulates recommendations for providing SHV physical dimensions, intended implant position and haemodynamic performance in a transparent, uniform manner. Furthermore, the Task Force advocates for the introduction and use of a standardized chart to assess the probability of prosthesis-patient mismatch and calls valve manufacturers to provide essential information required for SHV choice on standardized Valve Charts, uniformly for all SHV models.

Essential Information on Surgical Heart Valve Characteristics for Optimal Valve Prosthesis Selection: Expert Consensus Document From the European Association for Cardio-Thoracic Surgery (EACTS)-The Society of Thoracic Surgeons (STS)-American Association for Thoracic Surgery (AATS) Valve Labelling Task Force.

Comprehensive information on the characteristics of surgical heart valves (SHVs) is essential for optimal valve selection. Such information is also important in assessing SHV function after valve replacement. Despite the existing regulatory framework for SHV sizing and labelling, this information is challenging to obtain in a uniform manner for various SHVs. To ensure that clinicians are adequately informed, the European Association for Cardio-Thoracic Surgery (EACTS), The Society of Thoracic Surgeons (STS) and American Association for Thoracic Surgery (AATS) set up a Task Force comprised of cardiac surgeons, cardiologists, engineers, regulatory bodies, representatives of the International Organization for Standardization and major valve manufacturers. Previously, the EACTS-STS-AATS Valve Labelling Task Force identified the most important problems around SHV sizing and labelling. This Expert Consensus Document formulates recommendations for providing SHV physical dimensions, intended implant position and hemodynamic performance in a transparent, uniform manner. Furthermore, the Task Force advocates for the introduction and use of a standardized chart to assess the probability of prosthesis-patient mismatch and calls valve manufacturers to provide essential information required for SHV choice on standardized Valve Charts, uniformly for all SHV models.

Essential information on surgical heart valve characteristics for optimal valve prosthesis selection: Expert consensus document from the European Association for Cardio-Thoracic Surgery (EACTS)-The Society of Thoracic Surgeons (STS)-American Association for Thoracic Surgery (AATS) Valve Labelling Task Force.

Comprehensive information on the characteristics of surgical heart valves (SHVs) is essential for optimal valve selection. Such information is also important in assessing SHV function after valve replacement. Despite the existing regulatory framework for SHV sizing and labelling, this information is challenging to obtain in a uniform manner for various SHVs. To ensure that clinicians are adequately informed, the European Association for Cardio-Thoracic Surgery (EACTS), The Society of Thoracic Surgeons (STS) and American Association for Thoracic Surgery (AATS) set up a Task Force comprised of cardiac surgeons, cardiologists, engineers, regulatory bodies, representatives of the International Organization for Standardization and major valve manufacturers. Previously, the EACTS-STS-AATS Valve Labelling Task Force identified the most important problems around SHV sizing and labelling. This Expert Consensus Document formulates recommendations for providing SHV physical dimensions, intended implant position and hemodynamic performance in a transparent, uniform manner. Furthermore, the Task Force advocates for the introduction and use of a standardized chart to assess the probability of prosthesis-patient mismatch and calls valve manufacturers to provide essential information required for SHV choice on standardized Valve Charts, uniformly for all SHV models.

Aortic Root Dynamics in Sleeve Aortic Sparing Procedure: Echocardiographic and Computational Studies.

In Sleeve procedure, the leaflets-sinus unit is maintained. We hypothesized that this feature partially preserves aortic root (AR) dynamics and leaflets kinematics and limits tensions in the leaflets. We tested our hypothesis based on in vivo and computational assessment of leaflets and AR dynamics. AR and aortic leaflet kinematics was assessed by transthoracic echocardiography in 10 patients treated with the Sleeve procedure and in 10 healthy patients. Numerical calculations with the Finite Element Method were performed to support the analysis of the clinical results and provide a better understanding of the behavior of the AR treated via the Sleeve procedure. Echocardiographic evidence showed that AR expansion in the Sleeve group was partially preserved as compared to the Control group (2.9 ± 2.5% vs 7.7 ± 6.3%, P = 0.038) and of the sinotubular junction (2.9 ± 1.5% vs 7.3 ± 3.8%, P = 0.003), and significantly preserved at the Valsalva sinuses level (6.7 ± 2.6% vs 9.5 ± 4.3%) with not statistically significant differences (P = 0.11). In none of the cardiac phases, differences in aortic valve leaflets kinematics were measured between the 2 groups; computational results were rather consistent with this evidence. Computational results well matched echocardiographic evidences, allowing for their mechanistic interpretation. Near-normal opening and closing characteristics can be accomplished by a technique that preserves the shape and the dynamics of the Valsalva sinuses. Whether the substantial preservation of the AR distensibility and leaflets kinematics observed in this study will favorably affect long-term valve durability it remains to be ascertained.

Sleeve valve-sparing procedure in bicuspid aortic valve: early and midterm clinical results.

BACKGROUND: Patients with aortic root ectasia and bicuspid aortic valve benefit of the treatment with aortic valve sparing procedure, with excellent long-term results. The Sleeve-procedure is one of the options in patients with aortic root diseases and it might be suitable for patients with a bicuspid valve. METHODS: From October 2006 to December 2018, 42 consecutive patients with bicuspid aortic valve and aortic root ectasia/aneurysm, with or without aortic regurgitation, were surgically treated with the Sleeve-procedure. RESULTS: In 20 patients (48%) leaflets surgery was necessary and consisted of raphe mobilization/resection in 17 patients, plication of both leaflets in 2 patients and a two-commissures resuspension in 1 patient. During a mean clinical follow-up time of 4.4±3.1 years, the survival rate was 100%, 1 patient required a reoperation at 6.1 years postoperatively, with an overall freedom from reoperation of 94±5%. The rest of the patients (41/42), had no more than mild residual aortic valve regurgitation. With a mean follow-up of 4.3±1.7 years the magnetic resonance imaging performed in 26 patients, did not show signs of aortic wall herniation through the key-holes or persisting creases of the aortic wall inside the prosthesis. CONCLUSIONS: Patients with aortic root disease and bicuspid aortic valve may be treated with Sleeve technique with excellent midterm results. However, a longer follow-up is required before drawing any solid conclusion.

Effect of the valve design on pressure drop, pressure recovery, and spatial positioning of vena contracta.

BACKGROUND: Bioprostheses are complex structures and yield a very complex fluid dynamics. Hence, it can be hypothesized that prosthesis structural characteristics affect the position of the vena contracta and, consequently, influences the pattern and the extent of pressure recovery downstream from the vena contracta. MATERIALS AND METHODS: The study was performed on pericardial aortic prostheses, specifically Crown 21 and 23 (LivaNova PLC, UK), Trifecta 19 and 21 (Edwards Lifescience, USA), and Magna 19 and 21(Abbott, USA), tested in an "ad hoc" devised steady flow loop circuit at four flow rates (10, 15, 20, and 25 L/min). Fluid dynamic quantities were obtained by direct pressure measurement and Doppler interrogation. RESULTS: Pressure drop at 25 L/min flow rate was 26.5 ± 0.3 mm Hg and 14.9 ± 0.1 mm Hg for the Trifecta 19 and 21, 37.1 ± 1.0 mm Hg and 27.3 ± 0.4 mm Hg for the Magna 19 and 21, and 36.6 ± 1.0 mm Hg and 22.7 ± 0.1 mm Hg for Crown 21 and 23, respectively. The vena contracta was shorter for Trifecta compared with the Magna and the Crown in which it developed further downstream and as far as 1 cm from the valve leaflets fringes. The pressure recovery was 54% ± 1% for Trifecta 21, 39% ± 1% for Magna 21, and 41% ± 2% for Crown 23 with different patterns. CONCLUSION: The design of bioprosthesis affects pressure recovery and the position of the vena contracta. The different patterns of pressure recovery might have clinical impact.

4D Flow MRI hemodynamic benchmarking of surgical bioprosthetic valves.

PURPOSE: We exploited 4-dimensional flow magnetic resonance imaging (4D Flow), combined with a standardized in vitro setting, to establish a comprehensive benchmark for the systematic hemodynamic comparison of surgical aortic bioprosthetic valves (BPVs). MATERIALS AND METHODS: 4D Flow analysis was performed on two small sizes of three commercialized pericardial BPVs (Trifecta™ GT, Carpentier-Edwards PERIMOUNT Magna and Crown PRT®). Each BPV was tested over a clinically pertinent range of continuous flow rates within an in vitro MRI-compatible system, equipped with pressure transducers. In-house 4D Flow post-processing of the post-valvular velocity field included the quantification of BPV effective orifice area (EOA), transvalvular pressure gradients (TPG), kinetic energy and viscous energy dissipation. RESULTS: The 4D Flow technique effectively captured the 3-dimensional flow pattern of each device. Trifecta exhibited the lowest range of velocity and kinetic energy, maximized EOA (p < 0.0001) and minimized TPGs (p ≤ 0.015) if compared with Magna and Crown, these reporting minor EOA difference s (p ≥ 0.042) and similar TPGs (p ≥ 0.25). 4D Flow TPGs estimations strongly correlated against ground-truth data from pressure transducers; viscous energy dissipation proved to be inversely proportional to the fluid jet penetration. CONCLUSION: The proposed 4D Flow analysis pinpointed consistent hemodynamic differences among BPVs, highlighting the not negligible effect of device size on the fluidynamic outcomes. The efficacy of non-invasive 4D Flow MRI protocol could shed light on how standardize the comparison among devices in relation to their actual hemodynamic performances and improve current criteria for their selection.

Aortic root surgery with the CARDIOROOT vascular graft: results of a prospective multicenter post-market surveillance study.

BACKGROUND: Sparing Aortic Valve procedure requires to reproduction of the geometry of the physiologic anatomy of the aortic root. Thus, the materials adopted may make a difference. CARDIOROOT is a one-piece collagen-coated woven vascular graft with pseudo-sinuses, which was designed for use in the treatment of aortic root disease. We report the results of a prospective, multicenter, observational post-market surveillance study evaluating the safety and performance of the CARDIOROOT in patients requiring aortic root surgery. METHODS: Patients with aortic root disease suitable for treatment with a vascular graft with pseudo-sinuses CARDIOROOT graft were eligible for participation. The enrolled patients were assessed intraoperatively, post-operatively, at discharge and at 1-year. Sites assessed complications at each visit, and recorded any reported adverse events. The study endpoint was mortality and complications through 1-year post-procedure. RESULTS: Fifty-two patients were enrolled from 6 European centers. All procedures were technically successful. Operative mortality was 1.9%: one patient suffered hemorrhagic shock unrelated to the graft 1 day following surgery. At 1-year follow-up the survival rate was 96.2%, with a late death due to pneumonia 5 months post-procedure. Eleven serious adverse events occurred in 7 patients, which included cardiac complications (pericardial effusion, myocardial infarction and ventricular arrhythmia), infection (pericardial infection, deep sternal infection and superficial sternal infection), vascular disorders, including hemorrhagic shock and pleural effusion requiring drainage. Nine of the 11 events were deemed procedure-related by the local investigator, and all were deemed unrelated to the device. There were no reports of graft-related adverse events, infection, occlusion or graft failure. CONCLUSIONS: The results of this 1-year follow-up study showed that the CARDIOROOT vascular graft is safe and effective for the treatment of aneurysmal aortic root in immediate and mid-term follow-up. However, longer term follow-up is needed before conclusions can be made on the long-term safety and effectiveness. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01609270. Registered 31 May 2012.