Impact of United States artificial organ development in Latin America.

The University of Minnesota may be considered the cradle of heart surgery worldwide. That is where Dr. F. John Lewis carried out the first open heart surgery in September, 1952 and repaired an atrial septal defect in a 5 year old girl. Thenceforth, new solutions to allow systematic heart surgeries have been extensively investigated. This requires boldness and imagination. In 1954, Dr. Walton Lillehei, who had been working in Minnesota since after the war, carried out the first surgery with cross circulation using a second person who worked as a circulatory support, while the patient's heart was operated on. In 1955, he started using extracorporeal circulation using an oxygenator developed in association with Dr. Richard de Wall and the roller pump introduced by Michael DeBakey. By 1956 they had already performed 80 surgeries using the bubble oxygenator.

Pulsatile ventricular assist device with pericardial inner lining.

Preserved pericardium in contact with blood is not thrombogenic, therefore avoiding the use of anticoagulants, and has excellent mechanical properties. Our objective is to take advantage of these characteristics and build a pulsatile ventricular assist device (VAD) with pericardium used as the inner lining of the blood chamber. A mold is used for the tanning of the pericardium, rendering it with an exact shape. A flexible polymeric structure is designed to serve as a base for the pericardium, guiding it and limiting its rate of strain. It consists of two halves, which when outfitted with the interior pericardium lining and connected to each other, form the blood chamber. This assembly is housed in rigid polyvinyl chloride (PVC) shells making up the air chamber for the pneumatic activation. Valves are likewise made of pericardium. Sealing of the chambers was tested statically up to 300 mm Hg with no air or fluid leakage. The device was tested for 60 continuous days in a mock loop, demonstrating hydrodynamic performance adequate for ventricular assist. Micrographs (confocal laser and scanning electron microscopy) were obtained of several pericardium areas, especially on the flexing regions that are a transition between the wet and dry regions. No sign of damage to the pericardium was observed either with the naked eye or at the microscopic level. From the hydraulic performance and materials viewpoints, a completely pericardium-lined pulsatile VAD displaying a polymeric structure that avoids unpredictable bending and limits strain is feasible. The results warrant further studies regarding biocompatibility and strength advantages.

Mechanical behavior and stability of the internal membrane of the InCor ventricular assist device.

This paper describes and analyzes the mechanical behavior of the internal membrane of the InCor VAD (Heart Institute [InCor], University of São Paulo, Brazil), applying the knowledge and tools of structural engineering analysis. This membrane plays an important role in the operation of the ventricular assist device (VAD) because it separates the blood chamber from the pneumatic one, transmitting the pneumatic load to the blood, thus making the desired blood flow possible. The loading repeats itself every time the VAD beats. Therefore the performance, reliability, and durability of the membrane are critical for the performance of the VAD. The mathematical model is based on the large deflection theory of thin shells and on the finite element method. The snap-through instability phenomenon, which is responsible for transmission of the pneumatic load to the blood, was observed in the membrane both when modeled mathematically and experimentally. Principal stresses and strain distributions were obtained with this model at certain load levels along the pre- and postbuckling paths.

Nonstimulated cardiomyoplasty improves hemodynamics in myocardial-infarcted rats.

Cardiomyoplasty has been proposed as an alternative surgical treatment for congestive heart failure. The girdling effect of the muscle wrap is believed to reduce diastolic wall stress. We tested the hypothesis that nonstimulated or passive cardiomyoplasty (CDM) would reduce hemodynamic deficits in rats with experimentally induced myocardial infarction (MI). Four groups of animals were studied: intact (C, n = 6), CDM (n = 6), MI by ligation of the left coronary artery (n = 6), and left latissimus dorsi CDM performed 14 days post-MI (MI + CDM, n = 6). All groups were studied 8 weeks after MI and/or CDM or from the beginning of the experiment in controls. MI rats had a lower mean arterial pressure and higher end-diastolic pressure (EDP) compared with controls. End-diastolic pressure (EDP) and the left ventricular-body weight ratio (LV/BW) were reduced in the MI group after CDM. These data suggest that passive girdling of the heart provided by CDM may improve post-MI cardiac function.

Influence of biopump with and without intraaortic balloon on the coronary and carotid flow.

BACKGROUND: The objective of this study was to evaluate the influence of biopump used for left ventricular assistance on the coronary and carotid flows in dogs with normal heart. The efficacy of the simultaneous use of an intraaortic balloon pump to compensate the possible deleterious effects of the circulatory assistance with continuous flow was also analyzed. METHODS: Fifteen dogs were studied. The hemodynamic evaluation included serial measurements of the classic parameters. Carotid and coronary blood flows were obtained by electromagnetic transducers. RESULTS: The hemodynamic evaluation did not show significant statistical changes. The use of circulatory-isolated assistance with biopump shows reduction (24.6% +/- 6.1%) in coronary flow, in relation to the control situation and the concomitant use of biopump and intraaortic balloon pump showed similar coronary flow. Regarding carotid flow, a similar trend was observed in relation to the positive influence of the pulsatile flow with an intraaortic balloon pump without statistical significance (p = 0.0582). CONCLUSIONS: The biopump reduces the coronary flow in dogs. The use of intraaortic balloon pump with the biopump increases the coronary flow significantly, reaching similar values to those observed without the circulatory assistance.

A simplified single pump circuit for cardiac bypass with autogenous oxygenation.

A simplified extracorporeal circulation (ECC) assemblage with autogenous oxygenation (AO) using a single centrifugal pump was tested in dogs. The transpulmonary gradient was obtained by increasing pressure in the right atrium through volume expansion and decreasing it in the left atrium by collecting the blood from the pulmonary veins in a reservoir placed below the level of the animal, generating a siphon effect. This arrangement dispenses with a right side pump. The heart was electrically fibrillated after perfusion was started and defibrillated at the end of the bypass. This ECC circuit allowed the maintenance of adequate hemodynamic and blood gas parameters during the bypass. The operating field and the mobility of the heart were equivalent to that of conventional cardiopulmonary bypass (CPB). We conclude that the use of a single centrifugal pump simplifies the autogenous oxygenation approach, making it a practical choice for the coronary artery bypass graft (CABG) procedure.

Canine latissimus dorsi muscle: an apparatus for isometric force measurements.

This paper describes a device used to measure the isometric forces generated during electrical stimulation of the canine latissimus dorsi muscle in vivo with a preserved neurovascular supply. This device uses 2 strain gauge force sensors linked to a movable alignment frame to which the muscle is attached. The muscle length is controlled by the application of known weights to the system. The device has a frequency of response of 17.5 Hz and compliance of approximately 0.1 mm N(-1), and its experimental performance was tested in the anesthetized mongrel dog.

A dedicated prosthesis for open thoracostomy.

Due to our dissatisfaction with the mutilation caused by the skin-lined open thoracostomy, we have developed a dedicated prosthesis that is expected to avoid or to substitute for the classic operation. The prosthesis is a corrugated silicone tube with an oval flange at one end (to fix it internally) and a mobile ring on the other (to fix it externally). It is inserted at the bottom of the empyematic cavity after 3 cm of a rib is removed. We have used it in 20 patients whose empyema was secondary to pneumonia (12) or complications of pneumonectomy (4), lobectomy (2), decortication (1), or pleuroscopy (1). Six of those patients have already been cured and their prosthesis removed after 54 to 305 days. In 1 with a persistent postpneumonectomy bronchopleural fistula the device was removed after 299 days and the patient was submitted to a limited thoracoplasty. Six other patients still have unresolved cavities and have been using the prosthesis for 63 to 302 days. Seven patients died of their underlying disease (bilateral pneumonia, 2; acquired immunodeficiency syndrome, 2; mesothelioma, 1; heart failure and pulmonary embolism, 1; unknown, 1) after using the prosthesis for 11 to 160 days. In those patients from whom the prosthesis already has been removed, the scar looks like those commonly seen after removal of an ordinary chest tube. Based on these early favorable results we feel most encouraged to persist in this research. Nevertheless, we are aware that a larger number of patients and a longer follow-up will be necessary before we may make definitive recommendations.

Extracorporeal circulation with autogenous oxygenation: hemodynamic and gasometric parameters.

Ten experimental perfusions with autogenous oxygenation were performed in mongrel dogs to evaluate the efficacy of the procedure in maintaining normal hemodynamic the efficacy of the procedure in maintaining normal hemodynamic conditions and adequate blood gases for 1 h. Blood was drained from the right and left atria and pumped to the pulmonary artery and aorta, respectively. Two closed circuits containing compliant chambers and roller pumps were utilized. Artificial ventilation with an FiO2 of 50% were used in 5 animals and with an FiO2 level of 30% in the other 5. EKG, cardiac output, aortic, pulmonary artery, and left atrium pressures were registered. Pulmonary tissue was biopsied after perfusion. The heart was electrically fibrillated after perfusion was established and defibrillated at the end of the bypass. The procedure was able to maintain blood gases and pulmonary, aortic, and left atrial pressures within normal ranges during the perfusion. The mobility of the heart and the access to all coronary arteries was excellent. Clinical central nervous system evaluation, EKG tracings, and pulmonary histological exams showed no adverse effects of perfusion. We conclude that the technique employed may present a suitable proceeding for extracorporeal circulation in closed heart surgeries, and its clinical application should be evaluated as a safe and economical alternative.

Effects of muscle length, frequency of stimulation, and fatigue on the isometric tension in canine latissimus dorsi.

An experimental protocol was designed to study the mechanical response of the canine latissimus dorsi muscle stimulated to contract isometrically. Active and passive tensions were measured with the muscle's initial length varying within 10% of its physiologic length in situ. The force-frequency relationship was obtained at frequencies of stimulation of 1, 10, 15, 30, and 60 Hz. Muscle fatigability was assessed during 3 min of successive contractions. Tests were performed in pedicled muscles of anesthetized mongrel dogs (n = 10). Force-length characteristics were found to affect evoked tension markedly. Maximal active tension was generated near the muscle length in situ. Specific isometric tension measured with unit pulse stimulation was 2 +/- 0.4 N/cm2, and the time to peak twitch was 92.8 +/- 2.67 ms. With 60 Hz of stimulation frequency, the tension was 9.31 +/- 0.32 N/cm2, and the time to peak tension was 216.05 +/- 16.28 ms. After the fatigue test, the tension generated decreased to 62.5% of its initial value, and this decline was paralleled by the rate of tension development and tension relaxation.

Clinical comparison of blood oxygenators: a retrospective study.

The results for platelet count (PC), activated clotting time (ACT), postoperative bleeding, and hemoderivatives usage in cardiac surgeries were crossed against the type of oxygenator used. These were two bubble and one membrane type. A sample of the surgery population for each type was selected at random. Thus, the patients in this study were divided into 3 groups: BA: 87 patients, bubble oxygenator; BB: 87 patients, bubble oxygenator; M: 73 patients, membrane oxygenator. The groups were statistically similar (p > 0.05) for age, body surface area, cardiopulmonary bypass (CPB) time, and prevalence of cardiac disease. The rate of PC 15 min after CPB end and before its beginning was BA, 0.48 +/- 0.02; BB, 0.49 +/- 0.02; M, 0.55 +/- 0.03. The rate of ACT after protamine administration and before CPB was BA, 1.22 +/- 0.03; BB, 1.16 +/- 0.03; M, 1.16 +/- 0.03. Volume (ml) of total postoperative bleeding (POB) was BA, 904 +/- 72; BB, 963 +/- 73; M, 867 +/- 83. Patient percentage that used hemoderivatives (HD) was BA, 86.3%; BB, 88.5%; M, 90.0%. No statistical difference was found between groups (p > 0.05). This study indicates that although membrane oxygenators have better theoretic and experimental biocompatibility, no significant difference in PC, ACT, POB, and HD usage was observed in the clinical setting. All values are expressed as the mean +/- standard error of the mean.

Design, manufacturing, and testing of a paracorporeal pulsatile ventricular assist device: São Paulo Heart Institute VAD.

This paper describes the design of a ventricular assist device (VAD), its manufacturing, and testing. The VAD presented is pulsatile, with a free-floating membrane, smooth internal surfaces, and pericardial valves. It comprehends also a pneumatic driving unit capable of operating in the "full to empty," EKG synchronized or asynchronous modes. In vitro tests were performed to assess its mechanical durability, hydrodynamic performance, and hemolysis. To optimize cannulas and implant techniques, we performed in vivo tests in 22 sheep and 8 calves. In these tests, we also evaluated hemolysis and the device's capacity to normalize hemodynamic parameters during induced cardiac failure. The VAD worked for 4,000 h without failure in a mock circulatory loop. In full to empty mode, it displayed a rate-mediated "Starling-like" performance. Optimum output was achieved with a systole duration of 40% of the cycle. The in vitro hemolysis index (IH) was 6.7 +/- 2.1. Hemolysis in animal experiments was clinically nonsignificant. In calves with induced cardiac failure, the VAD was able to normalize hemodynamic parameters within 120 min.

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

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.

A pathway for information transmission to the inner ear. Application to cochlear implants.

The use of cochlear implants as an aid to neurosensory deafness is becoming an established procedure. The transmission of a processed speech signal is accomplished either transcutaneously via radiofrequency or percutaneously by connector coupling. Whereas the former is sensitive to electromagnetic interference, the latter increases the risk of infection. To overcome these disadvantages, an infrared (IR) system for transmission through the tympanic membrane was devised and tested. The transmitter/receiver consisted of an IR light emitting diode (LED; 920 nm) and a photovoltaic cell. The LED was placed inside the auditory canal of four dogs and the photovoltaic cell in the tympanic cavity over the cochlear promontory. A sinusoidal signal modulation was applied to the LED. The emitted signal was detected undistorted after crossing the tympanic membrane, with an average absorbance of 20%. High frequency cut-off was adequate for cochlear implant purposes and audio prosthetic devices in general. The authors conclude that the tympanic membrane may be used as a translucent sealed interface to transmit data in the audio range to the middle and inner ears, with small power loss, good frequency response, and immunity to interference.

A non-conventional reniform heart valve bioprosthesis with improved performance.

Conventional bioprosthetic heart valves have been designed with circular mounting rings. This article describes a mitral bioprosthetic valve consisting of three bovine pericardial leaflets with a "reniform" base. Its shape resembles that of the mitral anulus, and therefore, it provides a better anatomic fit. Hydrodynamic comparisons were made between conventional valves (CV) and equivalent sized reniform valves (ERV) that would adapt to the same anulus. Under steady flow of 30 L/min, pressure drops were compared in CVs and ERVs. For CV sizes 27, 29, and 31mm, the ratios of pressure drops compared with ERVs were 2, 1.49, and 1.30, respectively. With the same flow rate, the ratios of effective orifice areas (EOA) for CVs and ERVs in sizes 27, 29, and 31mm were 1.41, 1.21, and 1.14, respectively. Under pulsatile flow (mean flow, 5 L/min, 100 beats/min [bpm]), the pressure drop across CVs was averaged for sizes 27, 29, and 31mm, and found to be 1.51-fold the averaged pressure drops for ERVs. In addition, ERV sizes 27, 29, and 31mm had EOAs averaging 1.24-fold those of CVs. Similarly, for an 80 bpm frequency, the pressure drops across CVs for the three sizes averaged 1.48-fold that of ERVs. The EOAs of ERVs were 1.22-fold those of CVs averaged for the three sizes.

Alternative parameters for evaluating the performance of skeletal muscle in cardiac assistance.

This article describes a system designed to study the force, intramuscular pressure (IP), thickening (TH), and electromyographic (EMG) activity of the latissimus dorsi muscle in response to electrical stimulation. Experiments were carried out on fresh unconditioned muscles freed from the left flank insertion and fixed to contract isometrically. Statistical analysis of the data obtained demonstrated that IP and EMG activity were linearly related to force. The thickening of the muscle was found to be sensitive only to large variations in force, in a linear fashion.