RESUMEN
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.
Asunto(s)
Embolización Terapéutica , Intervención Coronaria Percutánea , Humanos , Aorta Torácica , Intervención Coronaria Percutánea/efectos adversos , Aorta/diagnóstico por imagen , Aorta/cirugía , StentsRESUMEN
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.
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Aneurisma Falso , Procedimientos Quirúrgicos Cardíacos , Seno Aórtico , Humanos , Aneurisma Falso/complicaciones , Aneurisma Falso/diagnóstico por imagen , Aneurisma Falso/cirugía , Seno Aórtico/diagnóstico por imagen , Seno Aórtico/cirugía , Procedimientos Quirúrgicos Cardíacos/efectos adversos , Bloqueo Cardíaco/complicacionesRESUMEN
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.
Asunto(s)
Estenosis de la Válvula Aórtica , Bioprótesis , Oclusión Coronaria , Implantación de Prótesis de Válvulas Cardíacas , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Aorta Torácica/cirugía , Falla de Prótesis , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/métodos , Perfusión , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/cirugía , Diseño de Prótesis , Resultado del TratamientoRESUMEN
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.
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Aneurisma Falso , Seno Aórtico , Heridas no Penetrantes , Aneurisma Falso/diagnóstico por imagen , Aneurisma Falso/etiología , Aneurisma Falso/cirugía , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Humanos , Seno Aórtico/diagnóstico por imagen , Seno Aórtico/cirugía , Resultado del Tratamiento , Heridas no Penetrantes/complicaciones , Heridas no Penetrantes/diagnóstico por imagenRESUMEN
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.
Asunto(s)
Prótesis Valvulares Cardíacas , Válvula Aórtica , Hemodinámica , Imagen por Resonancia Magnética , Espectroscopía de Resonancia Magnética , Diseño de PrótesisRESUMEN
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.
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Prótesis Valvulares Cardíacas , Cirujanos , Cirugía Torácica , Consenso , Válvulas Cardíacas , Humanos , Prótesis e Implantes , Estados UnidosRESUMEN
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.
Asunto(s)
Implantación de Prótesis de Válvulas Cardíacas/normas , Prótesis Valvulares Cardíacas/normas , Diseño de Prótesis/normas , Árboles de Decisión , HumanosRESUMEN
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.
Asunto(s)
Enfermedades de las Válvulas Cardíacas/cirugía , Implantación de Prótesis de Válvulas Cardíacas/normas , Prótesis Valvulares Cardíacas/normas , Válvula Aórtica/patología , Válvula Aórtica/cirugía , Bioprótesis/normas , Enfermedades de las Válvulas Cardíacas/patología , Válvulas Cardíacas/patología , Válvulas Cardíacas/cirugía , Hemodinámica/fisiología , HumanosRESUMEN
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.
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Insuficiencia de la Válvula Aórtica , Prótesis Valvulares Cardíacas , Animales , Aorta , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Fenómenos Biomecánicos , Florida , PorcinosRESUMEN
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.
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Válvula Aórtica/fisiopatología , Bioprótesis , Prótesis Valvulares Cardíacas , Diseño de Prótesis , Válvula Aórtica/cirugía , Presión Sanguínea/fisiología , Implantación de Prótesis de Válvulas Cardíacas , Hemodinámica , Humanos , Modelos Cardiovasculares , Pericardio/trasplanteRESUMEN
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.
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Aneurisma de la Aorta Torácica/cirugía , Insuficiencia de la Válvula Aórtica/cirugía , Válvula Aórtica/anomalías , Procedimientos Quirúrgicos Cardíacos/métodos , Enfermedades de las Válvulas Cardíacas/cirugía , Implantación de Prótesis de Válvulas Cardíacas/métodos , Monitoreo Fisiológico/métodos , Adulto , Aneurisma de la Aorta Torácica/diagnóstico por imagen , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Insuficiencia de la Válvula Aórtica/diagnóstico por imagen , Insuficiencia de la Válvula Aórtica/mortalidad , Enfermedad de la Válvula Aórtica Bicúspide , Procedimientos Quirúrgicos Cardíacos/mortalidad , Estudios de Cohortes , Femenino , Estudios de Seguimiento , Enfermedades de las Válvulas Cardíacas/diagnóstico por imagen , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Humanos , Imagen por Resonancia Cinemagnética/métodos , Masculino , Persona de Mediana Edad , Tratamientos Conservadores del Órgano , Estudios Retrospectivos , Medición de Riesgo , Factores de Tiempo , Resultado del Tratamiento , Adulto JovenRESUMEN
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.
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Estenosis de la Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/diagnóstico por imagen , Benchmarking , Bioprótesis/normas , Prótesis Valvulares Cardíacas/normas , Imagen por Resonancia Magnética , Diseño de Prótesis/normas , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/cirugía , Hemodinámica , Humanos , Imagenología Tridimensional , Técnicas In Vitro , CinéticaRESUMEN
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.
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Aorta/cirugía , Aneurisma de la Aorta/cirugía , Insuficiencia de la Válvula Aórtica/cirugía , Válvula Aórtica/cirugía , Ecocardiografía , Modelos Cardiovasculares , Modelación Específica para el Paciente , Procedimientos Quirúrgicos Vasculares , Adulto , Aorta/diagnóstico por imagen , Aorta/fisiopatología , Aneurisma de la Aorta/diagnóstico por imagen , Aneurisma de la Aorta/fisiopatología , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/fisiopatología , Insuficiencia de la Válvula Aórtica/diagnóstico por imagen , Insuficiencia de la Válvula Aórtica/fisiopatología , Fenómenos Biomecánicos , Estudios de Casos y Controles , Femenino , Análisis de Elementos Finitos , Hemodinámica , Humanos , Masculino , Persona de Mediana Edad , Valor Predictivo de las Pruebas , Recuperación de la Función , Resultado del Tratamiento , Procedimientos Quirúrgicos Vasculares/efectos adversosRESUMEN
Intraoperative surgical prosthetic heart valve (SHV) choice is a key determinant of successful surgery and positive postoperative outcomes. Currently, many controversies exist around the sizing and labelling of SHVs rendering the comparison of different valves difficult. To explore solutions, an expert Valve Labelling Task Force was jointly initiated by the European Association for Cardio-Thoracic Surgery (EACTS), The Society of Thoracic Surgeons (STS) and the American Association for Thoracic Surgery (AATS). The EACTS-STS-AATS Valve Labelling Task Force, comprising cardiac surgeons, cardiologists, engineers, regulators and representatives from the International Organization for Standardization (ISO) and major valve manufacturers, held its first in-person meeting in February 2018 in Paris, France. This article was derived from the meeting's discussions. The Task Force identified the following areas for improvement and clarification: reporting of physical dimensions and characteristics of SHVs determining and labelling of SHV size, in vivo and in vitro testing and reporting of SHV haemodynamic performance and thrombogenicity. Furthermore, a thorough understanding of the regulatory background and the role of the applicable ISO standards, together with close cooperation between all stakeholders (including regulatory and standard-setting bodies), is necessary to improve the current situation. Cardiac surgeons should be provided with appropriate information to allow for optimal SHV choice. This first article from the EACTS-STS-AATS Valve Labelling Task Force summarizes the background of SHV sizing and labelling and identifies the most important elements where further standardization is necessary.
Asunto(s)
Enfermedades de las Válvulas Cardíacas/cirugía , Implantación de Prótesis de Válvulas Cardíacas , Prótesis Valvulares Cardíacas , Etiquetado de Productos/métodos , Sociedades Médicas , Cirugía Torácica , Europa (Continente) , Humanos , Diseño de Prótesis , Estados UnidosRESUMEN
Intraoperative surgical prosthetic heart valve (SHV) choice is a key determinant of successful surgery and positive postoperative outcomes. Currently, many controversies exist around the sizing and labelling of SHVs rendering the comparison of different valves difficult. To explore solutions, an expert Valve Labelling Task Force was jointly initiated by the European Association for Cardio-Thoracic Surgery (EACTS), The Society of Thoracic Surgeons (STS) and the American Association for Thoracic Surgery (AATS). The EACTS-STS-AATS Valve Labelling Task Force, comprising cardiac surgeons, cardiologists, engineers, regulators and representatives from the International Organization for Standardization (ISO) and major valve manufacturers, held its first in-person meeting in February 2018 in Paris, France. This article was derived from the meeting's discussions. The Task Force identified the following areas for improvement and clarification: reporting of physical dimensions and characteristics of SHVs determining and labelling of SHV size, in vivo and in vitro testing and reporting of SHV hemodynamic performance and thrombogenicity. Furthermore, a thorough understanding of the regulatory background and the role of the applicable ISO standards, together with close cooperation between all stakeholders (including regulatory and standard-setting bodies), is necessary to improve the current situation. Cardiac surgeons should be provided with appropriate information to allow for optimal SHV choice. This first article from the EACTS-STS-AATS Valve Labelling Task Force summarizes the background of SHV sizing and labelling and identifies the most important elements where further standardization is necessary.
Asunto(s)
Regulación Gubernamental , Prótesis Valvulares Cardíacas , Etiquetado de Productos/legislación & jurisprudencia , Comités Consultivos , Unión Europea , Prótesis Valvulares Cardíacas/normas , Humanos , Diseño de Prótesis , Sociedades Médicas , Cirugía Torácica , Estados UnidosRESUMEN
Intraoperative surgical prosthetic heart valve (SHV) choice is a key determinant of successful surgery and positive postoperative outcomes. Currently, many controversies exist around the sizing and labeling of SHVs rendering the comparison of different valves difficult. To explore solutions, an expert Valve Labelling Task Force was jointly initiated by the European Association for Cardio-Thoracic Surgery (EACTS), The Society of Thoracic Surgeons (STS) and the American Association for Thoracic Surgery (AATS). The EACTS-STS-AATS Valve Labelling Task Force, comprising cardiac surgeons, cardiologists, engineers, regulators and representatives from the International Organization for Standardization (ISO), and major valve manufacturers, held its first in-person meeting in February 2018 in Paris, France. This article was derived from the meeting's discussions. The Task Force identified the following areas for improvement and clarification: reporting of physical dimensions and characteristics of SHVs determining and labeling of SHV size, in vivo and in vitro testing, and reporting of SHV hemodynamic performance and thrombogenicity. Furthermore, a thorough understanding of the regulatory background and the role of the applicable ISO standards, together with close cooperation between all stakeholders (including regulatory and standard- setting bodies), is necessary to improve the current situation. Cardiac surgeons should be provided with appropriate information to allow for optimal SHV choice. This first article from the EACTS-STS-AATS Valve Labelling Task Force summarizes the background of SHV sizing and labeling and identifies the most important elements where further standardization is necessary.
Asunto(s)
Bioprótesis/normas , Cardiología/normas , Seguridad de Productos para el Consumidor/normas , Implantación de Prótesis de Válvulas Cardíacas/instrumentación , Implantación de Prótesis de Válvulas Cardíacas/normas , Prótesis Valvulares Cardíacas/normas , Etiquetado de Productos/normas , Diseño de Prótesis/normas , Toma de Decisiones Clínicas , Consenso , Análisis de Falla de Equipo/normas , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Humanos , Selección de Paciente , Falla de Prótesis , Sociedades MédicasRESUMEN
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.
Asunto(s)
Aneurisma de la Aorta Torácica/cirugía , Implantación de Prótesis Vascular/instrumentación , Adulto , Anciano , Aneurisma de la Aorta Torácica/mortalidad , Europa (Continente) , Femenino , Humanos , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias , Vigilancia de Productos Comercializados , Estudios Prospectivos , Diseño de Prótesis , Tasa de Supervivencia , Adulto JovenRESUMEN
Hydrodynamic performance of stented bioprostheses is far below that of the native valve. One of the reasons is that the internal diameter of the prosthesis is usually smaller than that of the native valve. However, other valve characteristics are also important in generating the pressure drop. We aimed to assess, in an ex vivo pulsatile mock loop, the hydrodynamic behavior of two bioprostheses, Trifecta and Mitroflow, to ascertain which geometric terms are limiting factors in hydrodynamic performance. At stroke volumes between 30 and 60 ml, Trifecta showed lower pressure drop, energy dissipation and valve resistance, and greater effective orifice area. This trend was overturned at higher stroke volumes, with Mitroflow slightly outperforming Trifecta. The geometric determinants were consistent with these results. Trifecta achieved its maximum opening area already at the lowest stroke volumes, featuring a divergent shape at the systolic peak. Mitroflow showed a complex opening pattern, featuring a convergent shape at the systolic peak for lower stroke volumes, while reaching its maximum opening area at higher stroke volumes, with a divergent shape. The two bioprostheses, although similar in design, displayed different biomechanical behaviors. The internal diameter of each bioprosthesis did not show to be strictly correlated with its hydrodynamic characteristics.
Asunto(s)
Válvula Aórtica/cirugía , Implantación de Prótesis de Válvulas Cardíacas/métodos , Prótesis Valvulares Cardíacas/estadística & datos numéricos , Hemodinámica/fisiología , Animales , Válvula Aórtica/fisiopatología , Bioprótesis/estadística & datos numéricos , Hidrodinámica , Pericardio/cirugía , Diseño de Prótesis , Stents , Volumen Sistólico/fisiología , PorcinosRESUMEN
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.