A polyurethane trileaflet cardiac valve prosthesis: in vitro and in vivo studies.
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Biomedical subjects
Publications and source records attributed to W E Pae.
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A ventricular-assist pump was used to support the circulation in eight patients who could not be separated from cardiopulmonary bypass after open-heart operations. In five patients with left ventricular failure, the systemic circulation was maintained with pumping from the left atrium to the aorta for 7.0 +/- 1.8 days (mean +/- S.E.M.); three of these patients were well four to 17 months after surgery. In two patients with biventricular failure, right and left ventricular bypass supported the circulation, but neither patient survived. One other patient had isolated right ventricular failure; pumping from the right atrium to the pulmonary artery maintained the pulmonary circulation for 2.2 days. This patient lived for 18 months. Use of the ventricular-assist pump in our patients provided complete support of the systemic or pulmonary circulation or both. Profoundly depressed ventricular function is potentially reversible if technical problems in employing the pump can be avoided.
Left ventricular bypass may offer significantly better salvage of left ventricular myocardium in patients who remain hemodynamically unstable in spite of aggressive medical therapy and intra-aortic balloon support. Indeed, those 25 percent of patients refractory to intra-aortic balloon pumping may be salvageable with the prompt institution of left ventricular pumping assistance; however, just as early initiation of intra-aortic balloon pumping is critical, the early identification of balloon pumping failures and the institution of left ventricular bypass pumping may lead to a lower incidence of patients dependent on circulatory assistance and a higher rate of primary weaning. The results of left ventricular pumping assistance may indeed be totally different than those achieved with the intra-aortic balloon pump under these same conditions, because of the marked left ventricular unloading and hence the greater reduction in myocardial consumption of oxygen. The self-perpetuating cycle of progressive irreversible cardiac damage and shock may be broken, resulting in salvage of critical myocardial mass. Thus, cases of pumping dependence may be uncommon. There is also reason to believe that the heart without anatomically correctable lesions might function satisfactorily, but with a low cardiac reserve. Successful clinical application of left ventricular pumping assistance and subsequent analysis of therapeutic results demand a carefully devised protocol. This must be based on knowledge of the natural history of the disease and the results of previous sound clinical and experimental studies.
Stenosis remains a significant problem in vascular anastomoses performed in the growing patient. This study compares the growth of vascular anastomoses performed with either polypropylene or polyglycolic acid sutures. End-to-end infrarenal aortic anastomoses were performed in 18 piglets. Twelve were performed with polypropylene; in six all sutures were placed in a continuous fashion (Group 1A), and in the other six the posterior sutures were continuous and the anterior were interrupted (Group B). Six anastomoses were performed with polyglycolic acid sutures placed in a continuous fashion (Group 2). The animals were killed 6 months following operation. The abdominal aorta was removed, measured, burst tested, and subjected to histologic studies. All anastomoses were patent. There were no burst failures at 300 mm Hg mean pressure. All polypropylene sutures in Group 1A and the continuous portion in Group 1B had straightened without breaking. Straightening without polypropylene suture breakage resulted in stricture in three Group 1A anastomoses and one Group 1B anastomosis; there was intraluminal polypropylene suture material in two Group 1A and five Group 1B anastomoses. Bowstring formation of the straightened, continuous portion of the polypropylene suture in two Group 1A anastomoses and one Group 1B anastomosis resulted in adherent thrombus. Group 2 anastomoses were without stricture and were grossly indistinguishable from adjacent normal vessel. Histologic examination showed varying degrees of chronic inflammation in the polypropylene anastomoses but negligible inflammation in the polyglycolic acid anastomoses. These results suggest that continuous suture techniques with polypropylene in growing vessels may result in stenosis and/or thrombosis. Moreover, synthetic absorbable polyglycolic acid sutures will be of use in vascular anastomoses in growing patients and in cases in which exacting technique with minimal postsurgical inflammation may be crucial to patency.
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Following a posterolateral myocardial infarction, a 57-year-old man developed severe shock which did not respond to catecholamine infusion and intra-aortic balloon counterpulsation. Implantation of a left ventricular assist pump was planned, but at sternotomy free ventricular rupture was identified and repaired. Repair of free-wall ventricular rupture is uncommon because of infrequent antemortem diagnosis. A more aggressive surgical approach of instituting left ventricular assist pumping in those patients with cardiogenic shock refractory to medical therapy and intra-aortic balloon pumping should yield the additional benefit of repair of the rather common but rarely recognized lesion of ventricular rupture.
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Retrospective analysis of 14 patients undergoing circulatory support for postcardiotomy cardiogenic shock during the past 3 yrs has demonstrated the ability of the profoundly depressed myocardium to recover. Four patients were totally weaned from circulatory support and 2 are long-term survivors. Our results suggest that improved survival is dependent on the absence of certain peri-operative complications. To improve future clinical results we suggest that prompt application of assist pumping is necessary to eliminate prolonged cardiopulmonary bypass times and subsequent massive bleeding; those circulatory support systems requiring systemic anticoagulation are of no value in the treatment of postcardiotomy cardiogenic shock; the use of atrial cannulation may be advantageous in certain patients to eliminate critical inflow obstruction, further prolongation of cardiopulmonary bypass, and additional myocardial damage; and that the high incidence of right ventricular failure that is refractory to medical therapy makes the ability to support both ventricles mandatory.
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A controlled study was undertaken to quantitate and compare the effect of left ventricular bypass (LVB) and left atrial bypass (LAB on left ventricular infarct volume (LVIV). After baseline studies, the left anterior descending coronary artery in each of 30 mongrel dogs was ligated 1-1.5 cm from its origin. After baseline ischemic studies, control dogs (group 1--10 dogs), LAB dogs (group 2--10 dogs), and LVB dogs (group 3--10 dogs) were monitored for four hours. Final infarct size was determined by the nitroblue tetrazolium staining technique. Heart rate, mean arterial pressure, and total systemic flow (TSF) showed no significant difference between control and left heart bypass groups. In group 1, the LVIV was 27.7 +/- 6.5 g/100 g left ventricle (LV). In group 2, left heart bypass (LHB) flow was 90 +/- 4% of TSF. The pressure time index (PTI) was 2845 +/- 52 mm Hg-sec/min. The PTI demonstrated no significant difference from cntrols. In group 2, LVIV was 22.5 +/- 6.0 g/100 g LV. LVIV was reduced 18.8% from controls (p less than 0.08). In group 2, LHB was complete. Left ventricular decompression (group 3) resulted in a PTI of 328 +/- 76 mm Hg-sec/min. The PTI was significantly different (p less than 0.001) from groups 1 and 2. The LVIV was 12.6 +/- 5.1 g/100 g LV. LVIV was reduced 54.5% from controls (p less than 0.001) and 44.0% from group 2 (p less than 0.001). These results suggest that LVB may be useful, not only in supporting the circulation in the patient with myocardial infarct and cardiogenic shock, but also in limiting infarct size.
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A transcutaneous energy transmission system (TETS) has been used to power the Penn State motor driven ventricular assist device in nine calf experiments, for a total of 316 days of cumulative in vivo experience. This is seen as an important step toward a completely implantable ventricular assist system and total artificial heart. The TETS converts an external 12 volt DC source via inductive coupling to a regulated 14 volt output voltage for use by the motor controller. A maximum output power of 70 watts is available. In calf experiments, the TETS output power averaged between 8 and 12 watts. The motor controller was not implanted in these experiments, awaiting further development of the miniaturized electronics. The TETS output was returned percutaneously to the external motor controller, allowing the TETS output to be monitored directly. System efficiency, from DC source to DC output, and including losses in 12 feet of cable, ranged from 55% to 70%, depending upon supply voltage, motor load, and degree of coil coupling. The subcutaneous coil was well tolerated, demonstrating only temporary, mild, superficial induration.
Between September 1992 and April 1995, 19 patients at the authors' institution received pneumatic, pulsatile left ventricular assist devices (LVADs) for bridging to cardiac transplantation. The mean (+/- SD) age of the patients was 51 +/- 14 years (range, 19-64 years). Nine (47%) patients had end-stage idiopathic cardiomyopathy, five (26%) had ischemic cardiomyopathy, and five (26%) other recipients were in cardiogenic shock caused by acute myocardial infarction (AMI). Fifteen (79%) patients were supported with an intraaortic balloon pump or centrifugal LVAD at the time of LVAD insertion (duration, 5.5 +/- 4.1 days). Aprotinin was given to limit bleeding; heparin, followed by warfarin sodium, was used for anticoagulation. A vigorous exercise and nutrition protocol was followed. Cardiac index averaged 2.94 +/- 0.87 L/min/m2 immediately after the implantation procedure. No patient required placement of a right VAD. Average duration of LVAD support was 45 +/- 39 days (range, 3-153 days). Major complications included bleeding requiring reoperation (three patients); cerebrovascular accident (three patients); and severe dysrhythmias requiring direct current cardioversion (four patients). Fourteen (74%) patients underwent transplantation, with one patient still being mechanically supported. All of the patients receiving transplants were discharged from the hospital. Of the individuals who died while supported with the LVAD, 75% were patients with AMI. Timely application of LVADs as part of the interdisciplinary management of end-stage heart disease has generated excellent results for transplant candidates. Right ventricular dysfunction has not necessitated right VAD placement in the authors' experience. Patients with AMI have a higher risk of death while being supported with the device than do more chronically ill recipients.
In this study, a method to determine the existence of prosthetic heart valve cavitation in vivo is presented. Pennsylvania State University Left Ventricular Assist Devices (LVADs) were implanted in two separate calves for this study. Björk-Shiley Monostrut (Irvine, CA) 27 mm and 25 mm valves with Delrin occluders were used in the mitral and aortic positions, respectively. A high fidelity, piezoelectric pressure transducer was mounted approximately 1.25 cm proximal to the mitral valve and measured the high frequency pressure fluctuations caused by cavitation bubble formation and collapse after valve closure. The root mean square (RMS) value of the mitral pressure signal during a 5 ms interval after valve closure was used as a measure of cavitation intensity. The pressure signals observed in vivo were similar to ones observed in vitro with the same type of pressure transducer and were associated with the visually observed cavitation. The percentage of beats with cavitation increased from 20.3% to 67.7% when pump filling was decreased by increasing beat rate. A blood test conducted during post-operative days 1-3 showed a significant increase in plasma hemoglobin during the low filling condition. However, blood tests conducted later (post-operative days 7-44) did not show a significant change in plasma hemoglobin during low filling conditions.
Total Artificial Heart (TAH) development at Penn State University and 3M Health Care has progressed from design improvements and manufacturing documentation to in vitro and in vivo testing to characterize the system's hemodynamic response and energetic performance. The TAH system is completely implantable and intended for use as an alternative to transplantation. It includes a dual pusher plate pump and rollerscrew actuator, welded electronics and battery assembly, transcutaneous energy transmission system, telemetry, and a compliance chamber. In vitro testing was conducted on a Penn State mock circulatory loop with glycerol/water solution at body temperature. Tests were performed to characterize the preload and afterload response, left atrial pressure control, and power consumption. A sensitive preload response was demonstrated with left atrial pressure safely maintained at less than 15 mm Hg for flow rates up to 7.5 L/min. Variations in aortic pressure and pulmonary vascular resistance were found to have minimal effects on the preload sensitivity and left atrial pressure control. In vivo testing of the completely implanted system in its final configuration was carried out in two acute studies using implanted temperature sensors mounted on the electronics, motor, and energy transmission coil in contact with adjacent tissue. The mean temperature at the device-tissue interface was less than 4 degrees C above core temperature.
The development of a completely implanted total artificial heart at our institution has progressed to successful in vivo and in vitro testing of a device that is nearing clinical testing. This system consists of a 70 cc stroke volume pump originally designed to be used in men of average stature. Implantation of this system remains limited by patient size; hence, many women and adolescent patients will likely be precluded from support because of their smaller stature. A system similar in design, but with a 50 cc stroke volume pump has been developed. The first in vivo study of this device has been undertaken. A calf was supported for 33 days. The animal was extubated and ambulatory within the first 6 hours of implantation, and remained healthy until the thirty-third postoperative day when it suffered an embolic neurologic event. The pump and operating system worked flawlessly throughout the period of support. Further in vivo and in vitro testing will be undertaken. Development of a scaled down total artificial heart system expands this type of circulatory support to those critically ill patients previously deemed poor candidates because of their smaller body habitus.
We report the case history of a 47-year-old man who underwent orthotopic heart transplantation for ischemic cardiomyopathy. At the time of cardiectomy, the patient was found to have a persistent left superior vena cava draining into the coronary sinus and complete absence of his right superior vena cava. The donor heart had been removed without knowledge of this venous anomaly; consequently, the donor's superior vena cava and innominate vein were not harvested. The persistent left superior vena cava was cannulated for cardiopulmonary bypass. The recipient's heart was excised along the atrial ventricular groove, preserving the persistent left superior vena cava and coronary sinus. The atrial cuffs of the recipient and donor were fashioned for atrial-to-atrial anastomoses. Successful endomyocardial biopsies have been performed through the femoral veins after transplantation.