A multipurpose circulatory support system has been developed as both a temporary and permanent device in total artificial hearts (TAHs) and ventricular assist devices (VADs). The multipurpose concept was derived from the development of a totally implantable electromechanical, one-piece TAH. The blood pump is pneumatically driven in short-term use and is electromechanically driven in long-term or permanent use. Both TAH and VAD versions consist of the same components, except for the actuation mechanism. The common components are a compact pumping chamber with the same configuration, a blood contacting surface biolized with gelatin, a pusher-plate, a Hexsyn rubber diaphragm (University of Akron, Akron, OH) and bovine pericardial valves. Both TAHs and VADs have 63 ml of stroke volume, and the VADs are compact compared with other available investigational device exemption devices. Currently, 1 week survival has been achieved using the electromechanical TAH and 2 week survival using the electromechanimcal VAD without anticoagulation. Results suggest that the currently developed system could be applied in varied patients as a temporary device after cardiotomy, a long-term device for bridge to transplantation, or a permanent device for end-stage heart disease.

Assisted Circulation↗

PubMedDate not supplied

The role of pulsatility in end-organ microcirculation after cardiogenic shock.

To estimate the effectiveness of pulsatility in end-organ microcirculation after cardiogenic shock, experimental studies using swine were done. Cardiogenic shock was produced in 14 pigs by ligating the left anterior descending branches so that mean aortic pressure dropped to 60% of the control value. After inducing shock, left atrial to ascending Ao bypass was initiated. A pneumatic pulsatile pump (Zeon Medical Inc, Tokyo, Japan) was used in seven pigs (Group P) and a centrifugal pump (BP-80, BioMedicus Inc, Minneapolis, MN) in seven (Group NP). In both groups, about half the usual cardiac output was supported for 3 hr, maintaining mean aortic pressure at approximately 100 mm Hg. The pulse pressure was 36.6 +/- 4.6 mm Hg in Group P, and 14.3 +/- 1.5 mm Hg in Group NP. Epicardial and endocardial regional flows recovered after assist in both groups. There were no significant differences between the two groups. However, liver tissue flow, renal cortex flow, and stomach mucous flow in Group P was significantly higher than those of Group NP after support (p < 0.05). In addition, arterial blood ketone ratio in Group P was 0.61 +/- 0.13 vs 0.39 +/- 0.06 in Group NP, a significant difference (p < 0.05). These results suggest that in uneven blood flow distribution of end organs after cardiogenic shock, pulsatility was effective in improving and maintaining function and microcirculation of end organs, preventing multiorgan failure.

Animals↗

PubMedDate not supplied

Clinical evaluation of the Gyro Pump C1E3 as a cardiopulmonary bypass pump.

The Gyro Pump C1E3 is a new centrifugal pump with numerous features, including a ceramic pivot bearing system, secondary vanes, and an eccentric inlet port. To evaluate its biocompatibility, antithrombogenicity, and produced hemolysis, we used the Gyro Pump during cardiopulmonary bypass (CPB) for coronary artery bypass grafting (CABG) cases to compare it with the BioMedicus pump. From September 1998 to February 1999, 30 consecutive patients underwent CABG under conventional CPB. Fifteen patients were supported by the Gyro Pump C1E3 (Group G), and the remaining 15 patients, by a BioMedicus BP-80 pump (Group B). In both groups, flow rate was equivalent. Blood samples were taken as follows: preoperative, 60 minutes after the end of the procedure, and at postoperative days (POD) 0, 1, and 2. We evaluated the plasma free hemoglobin (free Hb) as an indication of hemolysis; beta-thromboglobulin (beta-TG) and platelet factor four (PF-4) as an indication of platelet deterioration; C3, C4, CH50 for complement activation; coagulation parameters, fibrinolytic factor, thrombomodulin, nitric oxide (NO), and endothelin as an indication of endothelial deterioration. This was the first clinical sized Gyro Pump CIE3. De-airing from the pump was easily accomplished via the eccentric oblique inlet port. The system, including its console, was easily and simply controlled. Perioperative laboratory data were not markedly changed in either group with demonstrated equivalence for biocompatibility and hemolysis. After pumping, no thrombus formation or pivot wear were observed inside the pump. This atraumatic, small centrifugal pump appears well suited not only for CPB but also for circulatory support.

Aged↗

PubMedDate not supplied

Endoscopic pericardial fenestration for a patient with sustained lupus pericarditis.

A 57-year-old woman was diagnosed in January 1982 with SLE based on ANA 1:640, positive LE cell preparation, proteinuria (3+), and pericarditis. In 1984, 1994, and 1997, the pericardial effusion was noted to have increased without signs of disease exacerbation or cardiac tamponade, and pericardial drainage was repeated to control the effusion. A massive pericardial effusion developed in August 1997. After tuberculosis, hypothyroidism, neoplasm, and progression of SLE were ruled out, we decided to perform pericardial fenestration. A safe and minimally invasive pericardial fenestration was successfully completed endoscopically. Pathologic study of the specimen revealed chronic pericarditis. We consider endoscopic pericardial fenestration to be useful for at risk patients with pericarditis to control the effusion and establish a differential diagnosis.

Endoscopy↗

PubMedDate not supplied

A unique, efficient, implantable, electromechanical, total artificial heart.

A completely implantable, one piece electromechanical total artificial heart (TAH) intended for permanent human use was developed. It consisted of left and right conically shaped pusher-plate blood pumps sandwiching a thin centerpiece with a compact, efficient electromechanical actuator. The actuator consisted of a direct current brushless motor; a planetary roller screw fit the space between the two conically shaped pusher-plates. The rotational motion of the motor was converted to the rectilinear motion of the rollerscrew to displace the left and right pusher-plates in the left master alternate mode. The diameter of the assembled TAH was 97 mm, with a central thickness of 82 mm. The overall weight was 620 g, with a displaced volume of 510 ml. The pump provided flows of 3-8 L/min with a preload of 1-15 mmHg against an afterload of 100 mmHg. The net efficiency ranged from 15% to 18%. This model showed good fit in the pericardial space of heart transplant recipients (body weight, 77 kg).

Cardiac Output↗

PubMedDate not supplied

A biolized, compact, low noise, high performance implantable electromechanical ventricular assist system.

An implantable electromechanical ventricular assist system (VAS) intended for permanent human use was developed. It consisted of a conically shaped pumping chamber, a polyolefin (Hexsyn) rubber diaphragm attached to a pusher-plate, and a compact actuator with a direct current brushless motor and a planetary rollerscrew. The outer diameter was 97 mm, and the total thickness was 70 mm. This design was chosen to give a stroke volume of 63 ml. The device weighs 620 g, with a total volume of 360 ml. The pump can provide 8 L/min flow against 120 mmHg afterload with a preload of 10 mmHg. The inner surface of the device, including the pumping chamber and diaphragm, was made biocompatible with a dry gelatin coating. To date, two subacute (2 and 6 day) calf studies have been conducted. The pump showed reasonable anatomic fit inside the left thorax, and the entire system functioned satisfactorily in both the fill-empty mode using the Hall effect sensor signals and the conventional fixed rate mode. There were no thromboembolic complications despite no anticoagulation therapy. The system now is being endurance tested greater than 10 weeks (9 million cycles). This VAS is compact, low noise, easy to control, and has excellent biocompatibility.

Animals↗

PubMedDate not supplied

Anatomic fit study for development of a one piece total artificial heart.

A fit study was conducted to define anatomic constraints to total artificial heart (TAH) insertion in 26 human orthotopic cardiac transplant recipients, and the parameters necessary for designing a totally implantable TAH were obtained from the excised heart. A multiadjustable fitting device was made (height, 118 mm; width, 81 mm; diameter, 97 mm), and with this model, 15 fitting and measuring studies were conducted to validate the design and demonstrate anatomic compatibility. Satisfactory fit of the contour model was observed in all cases. The model was placed through a sternotomy wound in the pericardial space. In addition to this mock-up fit study, the anatomic dimensions of the connection points to the TAH and the excised hearts also were measured. With the prototype model based on these data, a fit verification study was done in 11 recipients. Satisfactory fit in the pericardial space without compression of adjacent structures was observed in seven of 11 patients. This study suggests that the newly designed model of an anatomically and surgically practical configuration could be implanted in most patients in this population as a completely implantable cardiac prosthesis.

Anthropometry↗

PubMedDate not supplied

Intraoperative determination of mediastinal constraints for a total artificial heart.

The anatomic constraints to mediastinal fit of a total artificial heart (TAH) were largely neglected during the early developmental stages, precipitating failure due to compression or torsion of intrathoracic conduits and vascular structures. Cadaveric studies quantifying anatomic constraints are limited by postmortem factors causing distortion of critical structures. This study defines the anatomic constraints and parameters necessary for designing an implantable TAH. Importantly, these parameters were measured in 12 consecutive patients undergoing orthotopic cardiac transplant (mean body surface area, 2.0 +/- 0.1 m2) after native heart amputation. A full sized contour model of the cylindrical TAH (diameter, 97 mm; width, 78 mm) was inserted into the pericardial cavity to verify fit, which was found adequate in each case, with no identifiable compression of adjacent vascular structures. Intraoperative measurements obtained define intrathoracic and pericardial constraints for a cardiac prosthesis (mean pericardial dimensions: length, 133.0 mm; width, 154.0 mm; depth, 129.0 mm). The parameters measured will provide useful reference for other prosthetic devices, since they were obtained intraoperatively rather than postmortem. The current dimensions of our TAH were found to be acceptable for orthotopic implantation.

Adult↗

PubMedDate not supplied

Hemodynamic and hemolytic features of the St. Jude Medical valve prostheses.

We performed valvular replacement in 86 cases (108 valves, 43 males, 43 females) from July 1978 to July 1981 with St. Jude Medical valves which utilize two discs made of pyrolytic carbon and employ a bileaflet central opening system. Ages ranged from 13 to 68 years (average 42.3). For all cases in this study, we performed anti-coagulant therapy. The incidence of thromboembolic complication was zero. With regard to postoperative clinical evaluation on valve function and chronic hemolysis, we compared the cases of St. Jude Medical valves with those of Starr-Edwards (S.E.) valves (aortic: Model 2320, mitral: Model 6400), Carpentier-Edwards (C.E.) valves and cases of open mitral commissurotomy. As for valve function such as left atrioventricular diastolic pressure gradient, mitral effective orifice area both at rest and on exercise, the St. Jude Medical valve yielded best results. Next was the C.E. and third was the S.E. The results of the St. Jude Medical valve group and those of the open mitral commissurotomy group were equivalent. In comparison with ball type cardiac valve prostheses and bioprostheses, the St. Jude Medical valve has excellent hemodynamic characteristic. Concerning hemolysis, the St. Jude Medical was below only the C.E., however the degree of hemolysis was so low that the St. Jude Medical valve holds great promise as central flow mechanical valve prostheses.

Adolescent↗

PubMedDate not supplied

Anatomic constraints for a total artificial heart in orthotopic heart transplant recipients.

The anatomic constraints and design parameters for a heart prosthesis have not yet been defined in heart transplant recipients (i.e., the population most eligible for total artificial heart implantation). The parameters regarding anatomic constraints were measured in 26 consecutive patients undergoing orthotopic heart transplantation (median body surface area 1.9 m2) after cardiectomy. A full-sized contour model of the cylindric total artificial heart (diameter 97 mm; width 81 mm) was inserted into the pericardial cavity to decide the pump configuration and to verify its fit. The dimensions of this model were based on the miniature electromechanical total artificial heart that is currently under development. Fit was found to be adequate in most of the cases with no identifiable compression of adjacent vascular structures. The median intraoperative measurements that define pericardial constraints for a heart prosthesis were pericardial length (130 mm), width (160 mm), and depth (140 mm). We also took measurements from the excised hearts, which should provide a useful reference for other prosthetic devices. The current dimensions of our implantable total artificial heart were found acceptable for orthotopic implantation. Length of the pericardium and cardiothoracic ratio were identified as variables related to adequacy of fit.

Adult↗