In vitro and in vivo evaluation of lyophilized bioprosthetic valve.

Freeze-drying of biological tissues allows for dry storage and gamma ray sterilization, which may improve their use as a medical prosthesis. The objective of this study was to evaluate the rehydration characteristics and hydrodynamic performance of prosthetic valves before and after lyophilization. Two size 23 bovine pericardium aortic valve prostheses from different manufacturers were evaluated in a Shelhigh (Union, NJ, USA) pulse duplicator (80 ppm, 5 L/min) before and after lyophilization. Flow and transvalvular pressure gradient were registered in vitro and in vivo, and images of opening and closing of the prosthesis were obtained in the pulse duplicator in a digital camera. Rehydration was evaluated by comparison of dry valve weight with valve weight after 15 min, and 1, 24, 48, and 72 h in saline solution, inside the pulse duplicator. In vivo performance was assessed by surgical implantation in Santa Inês young male sheep in the pulmonary position after 30 min rehydration with 0.9% saline. Transvalvular pressure gradient and flow measurements were obtained immediately after implantation and 3 months after surgery when valves were explanted. Captured images showed a change in the profile opening and closing of valve prosthesis after lyophilization. The gradient measured (in vitro) in two valves was 17.08 ± 0.57 and 18.76 ± 0.70 mm Hg before lyophilization, and 34.24 ± 0.59 and 30.40 ± 0.97 mm Hg after lyophilization. Rehydration of both lyophilized valves was approximately 82%. Drying changed the profile of the opening and closing of valve prostheses, and increased on average by 83% the gradient in vitro tests. The result of the in vivo tests suggests maintaining pressure levels of the animal with the lyophilized prostheses within acceptable levels.

Projeto, construção e testes de um dispositivo de assistência ventricular pulsátil / Design, manufacturing and testing of a pulsatile ventricular assist device

PURPOSE--To describe the design of a ventricular assist device (VAD), its manufacturing and testing. METHODS--The VAD is pulsatile, with a free floating membrane, smooth internal surfaces, and pericardium valves. It comprises also a pneumatic driving unit capable of operating in the ®full to empty®, EKG synchronized or asynchronous modes. The system was tested ®in vitro® to assess its mechanical durability, hydrodynamic performance and hemolysis. ®In vivo® tests were performed in 22 sheep and 8 calves aiming at optimizing cannulas and implant techniques. In these experiments, hemolysis and the device's capacity of restoring to normal hemodynamic parameters during induced cardiac failure were evaluated. RESULTS--The device was worked 4,000 hours without failure in a mock circulatory loop. Hydrodynamic performance was satisfactory for adult circulatory support. In ®full to empty® mode it displayed a frequency mediated ®Starling like® performance. Optimum output was achieved with a systole duration of 40//of the cycle. ®In vitro® hemolysis index was 6.7 +/- 2.1. Hemolysis in animal experiments was clinically non significant. In calves under induced cardiac failure the VAD was able to normalize hemodynamic parameters within 120 minutes. CONCLUSION--This VAD is capable to circulatory assist for cardiogenic shock in conditions needed for an adult patient and the average time span anticipated for bridge to transplantation or post cardiotomy cardiogenic shock

Sistema para avaliaçäo "in vitro" da hemólise em bomba centrífuga / System for evaluation \"in vitro\" of hemolysis in centrifugal pump

Este trabalho apresenta um sistema para avaliação in vitro da hemólise produzida por uma bomba de fluxo contínuo do tipo centrifuga utilizada para assistência circulatória temporária. O sistema desenvolvido é composto por reservatório, trocador de calor, console para acoplamento e motor para acionamento da bomba, fluxômetro eletromagnético e transdutor de pressão. Para a validação do sistema utilizou-se bomba comercial (Biopump©) rotineiramente utilizada em assistência. Os experimentos foram realizados com sangue bovino fresco heparinizado (volume: 1000 ml, 37 Graus Celssius). A variação de hemoglobina livre plasmática foi medida ao longo de 4 horas, mantendo-se vazão 3,5 1/min contra uma pressão de 120 mmHg (R=1902).

Abstract - This paper presents a system developed for in vitro evaluation of hemolysis caused by a centrifugai type pump utilized for cardiac assistance. lt consists of a blood reservoir, a heat exchanger. pump actuator, electromagnetic flowmeter and pressure transducer. Experimental evaluation was performed utilizing a commercial centrifugal pump (Biopump®) running with fresh bovine blood (volume: 1000 ml, 37 ºC). Plasma free hemoglobin was measured during 4 Hs, at 3,5 l/min flow and 120 mmHg pressure gradient (~H=l 902)

Utilizaçäo de um sistema dedicado para a avaliaçäo "in vitro" de próteses valvares cardíacas / Utilizations of a system of evaluation \"in vitro\" of cardiac valve prosthesis

Apresentamos um sistema dedicado desenvolvido para avaliação "in vitro" de prótese valvares cardíacas. Este tipo de sistema é importante no desenvolvimento de novas próteses valvares além de ser utilizado para uma avaliação, de maneira comparativa, do desempenho e durabilidade que o sistema é apropriado para a valiação do desempenho de próteses de diferentes formas e materiais

Abstract - We present a dedicated system, developed for "in vitro" evaluation of cardiac valve prostheses. The system is used for testing new valvar prostheses and can be used for comparative evaluation of performance and durability of commercial valvar prostheses. The results obtained demonstrate that it allows performance testing of prostheses of different shapes and materiais

Desenvolvimento de uma protese de ventrículo artificial implantável / Development of a prosthesis of implanted artificial ventricle

O objetivo deste trabalho foi o desenvolvimento de uma prótese de ventrículo artificial implantável (VAI), para utilização em pacientes com insuficiência cardíaca profunda que necessitam de assistência circulatória mecânica, como ponte para transplante de coração. Foi utilizado um programa CAD (Microstation) para o projeto mecânico do VAI. O dispositivo apresenta uma membrana livre fixada entre duas crianças de titânio, seu acionamento é do tipo pneumático. O dispositivo foi projetado para ser implantado na cavidade abdominal e conectado ao coração nativo via ápice do ventrículo esquerdo e aorta, por meio de cânulas confeccionados em silicone, acopladas a válvulas biológicas de pericárdio bovino.

Abstract - This paper describes the design of an implantable artificial ventricular assist device to support the heart as a bridge to heart transplantation, in patients with profound cardiac failure. The artificial ventricle presented has a free floating membrane, dividing two titanium carcass. The driving unit is pneumatic. Two silicone cannulae are used to conect the device to the patient's heart ( left ventricle apex and aorta). Each cannula is eqquiped with one bovine pericardium valve. A computer program (Microstation) was utilized to provide volumetric calculus, bidimensional and tridimensional visualization to optimize the design