Sequence and task analysis of instrument use in common laparoscopic procedures.

BACKGROUND: In the area of instrument evaluation, one aspect that still requires objective assessment is the dynamics of instrument maneuver and exchange. If we could gain a better understanding of these phenomena, we could improve the design of the instruments themselves. METHODS: A total of 29 laparoscopic procedures were videotaped and reviewed using time motion analysis. Instrument multifunctionality was determined using a standardized list of laparoscopic maneuvers. State transition diagrams were utilized to document the sequence of instrument exchanges. RESULTS: The curved dissector, atraumatic grasper, and cautery scissors were identified as the most multifunctional instruments; each was able to perform five distinct maneuvers. Instrument sequences were found to consist of a three-part dissect --> clip --> cut cycle and a two-part dissect --> suction cycle of instrument exchange. CONCLUSION: This study demonstrated that laparoscopic instruments are often used to perform a variety of maneuvers in addition to their primary function. Furthermore, there are common patterns in instrument exchange that provide a potential source of design parameters for improved surgical efficiency.

A virtual reality surgical trainer for navigation in laparoscopic surgery.

A virtual reality trainer was designed to familiarize students and surgeons with surgical navigation using an angled laparoscopic lens and camera system. Previous laparoscopic trainers have been devoted to task or procedure training. Our system is exclusively devoted to laparoscope manipulation and navigation. Laparoscopic experts scored better than novices in this system suggesting construct validity. The trainer received favorable subjective ratings. This simulator may provide for improved navigation in the operating room and become a useful tool for residents and practicing surgeons.

Modifications in surgical implantation of the Penn State electric total artificial heart.

BACKGROUND: Two modifications of the surgical implantation protocol for the Penn State Total Artificial Heart (ETAH) were evaluated: Phrenic nerve ischemia was prevented by minimizing dissection and traction; and hemostasis was augmented and ETAH cuff anastomoses reinforced by using fibrin glue. METHODS: Thirteen Holstein calves underwent orthotopic surgical implantation of the Penn State ETAH between February 1998 and August 2000. Mean hemodynamic and laboratory chemistry variables from the first postoperative week were compared between calves receiving the original (n = 7) and modified (n = 6) protocol. RESULTS: Calves assigned to the modified protocol displayed an improvement in the Po2/FiO2 ratio compared to original (419.4 +/- 17.5 vs 336.3 +/- 35.4, respectively; p = 0.05). All additional parameters were equivalent between groups. The percent survival of animals receiving the modified protocol at 2, 4, and 12 weeks was higher than that of animals that underwent the original protocol. Original-protocol calf deaths consisting of hemothorax (n = 3), and respiratory failure (n = 1) were prevented in the modified protocol. CONCLUSIONS: Our results suggest that manipulations in surgical protocol may promote increased survival in calves implanted with the Penn State ETAH.

The LionHeart LVD-2000: a completely implanted left ventricular assist device for chronic circulatory support.

Management of patients with end-stage cardiac disease remains a vexing problem. Limitations in medical management and a fixed supply of donor organs for cardiac transplant have a continued impact on this growing population of patients. Mechanical circulatory support has proved very successful as a means of bridging patients to cardiac transplant when all medical options have been exhausted. The development of a chronic system of circulatory support has been underway at the Pennsylvania State University for nearly 30 years. These efforts have been recently merged with the industrial partnership with Arrow International toward the development of the LionHeart LVD-2000 (Arrow International, Reading, PA) completely implanted left ventricular support system. We present an overview of the system, details of implantation, a review of preclinical studies, and a synopsis of the first European implants. Early results have demonstrated the system to be safe, effective, and reliable. Transcutaneous energy transmission and the compliance chamber have been validated.

An investigation of the in vivo stability of poly(ether urethaneurea) blood sacs.

In this paper we investigate the biostability of a series of Biolon blood sacs that were utilized in electric total artificial hearts for time periods of up to 19 weeks. A battery of experimental probes, including scanning electron microscopy (SEM) and X-ray photoelectron spectroscopy (XPS), were used to characterize the bulk and surface properties of explanted and control blood sacs. Gel permeation chromatography (GPC) experiments showed that generally there was a dramatic increase in average molecular weight at longer implantation times. However, SEM and GPC observations suggest significant deterioration of the flex regions of right blood sacs after 17 weeks of service. XPS experiments indicated appreciable silicon and hydrocarbon concentrations on blood-contacting surfaces both before and after implantation, and we speculate as to their origin.

Dynamic in vitro and in vivo performance of a permanent total artificial heart.

In vivo characterization studies were performed to compare the dynamic in vivo performance of the Penn State/3M Health Care electric total artificial heart to existing in vitro data. Fully implanted systems were utilized including the artificial heart, controller, backup batteries, compliance chamber, and transcutaneous energy transmission. Catheters were implanted to measure central venous pressure (CVP), left atrial pressure (LAP), right atrial pressure (RAP), pulmonary artery pressure (PAP), and aortic pressure (AoP). Cardiac output (CO) was determined from the implanted controller, and systemic vascular resistance (SVR) was calculated. Steady state data were collected for each animal along with data regarding the transient responses to changes in preload and afterload. Preload was manipulated through volume changes. Afterload changes were accomplished through vasoactive agents. Increased preload caused little change in cardiac output because the pump output was nearly maximum at baseline. LAP, AoP, and SVR increased with increasing RAP. Decreased preload caused a reduction in CO, LAP, and SVR. Afterload increase resulted in a slight decrease in flow and an increase in system power and SVR. Afterload reduction was accompanied by a decrease in preload and a concomitant reduction in flow. Overall, the system response was similar to the response observed in vitro.

A long-term ventricular assist system.

An implantable, electrically powered pump that will provide tether-free circulatory support is being developed. The blood pump consists of a seamless polyurethane sac within a polysulfone case. Björk-Shiley Monostrut valves provide unidirectional flow. The blood sac is compressed by a pusher plate with a stroke of 1.9 cm and actuated by a brushless direct-current electric motor and motion translator. The current unit is completely sealed, and inductive coupling techniques provide the electrical energy. The system has an implantable electronic control system as well as a battery that provides 30 minutes of operation when the external coil is disconnected. During normal operation, however, the pump is powered by a portable battery pack or by house current. The unit can pump 8.5 L/min at physiologic pressures. Twenty-six animals have had circulatory support for a period of more than 1 week. The average period of pumping was 62 days; the longest was nearly 8 months. Experiments were terminated in 18 animals because of pump-related problems and in 8 because of biologically related problems. Studies to date are very encouraging and suggest that, with further refinement, a reliable 2-year assist pump that will have important clinical application can be developed.

Lower extremity amputations: basis and outcome, a review of the literature.

The authors present a designed approach to lower extremity amputations. The content includes conditions, types, and complications of amputations and emphasizes types of prosthetic devices. This review is intended to summarize the lower extremity amputation.

An electrically powered total artificial heart. Over 1 year survival in the calf.

An electric motor driven orthotopic artificial heart was implanted in a 110 kg female Holstein calf as part of a series of 12 such implants intended to demonstrate the in vivo durability and compatibility of the device. The device uses pusher plates set into motion by a reversing brushless DC motor and roller screw to alternately eject two cylindrical sac type blood pumps. The pumps use Bjork-Shiley Delrindisc convexo-concave or monostrut valves. The left pump provides an 88-90 ml dynamic stroke volume. Woven Dacron grafts and polyurethane coated Dacron/Lycra cuffs are used to attach the device to the major arteries and atria, respectively. A polyurethane conduit and anchoring skin button bring motor wires percutaneously to an extracorporeal controller. The controller provides balanced cardiac output sensitive to atrial or aortic pressures, without operator intervention. The system is hermetically sealed and uses a simple compliance sac to maintain thoracic pressure between the pumps. The calf recovered uneventfully from surgery and thrived thereafter. She was killed on the 388th post-operative day because of worsening cardiac insufficiency. The previous three operative survivors in this series lived 131, 134, and 204 days. These results indicate the device's good potential for durability and body compatibility.

An electric artificial heart for clinical use.

Advances in microelectronics, high-strength magnets, and control system design now make replacement of the heart using an implantable, electrically powered pump feasible. The device described herein is a compact, dual pusher plate unit with valved polyurethane sac-type ventricles positioned at either end. The power unit consists of a small, brushless direct current motor and a motion translator. A microprocessor control system is used to regulate heart beat rate and provide left-right output balance. Bench studies lasting for as long as 1 year have been performed. Heart replacement with the electric heart has been performed in 18 calves since 1984. The longest survivor lived for more than 7 months. Among the causes of termination were component failure, thromboembolic complications, and bleeding. No major problem has been identified that precludes prolonged use of the electric heart. In the future the patient with end-stage heart disease will have an electric artificial heart as one therapeutic option.

Current status of permanent total artificial hearts.

Pneumatic total artificial heats, although demonstrating utility as temporary mechanical circulatory support devices, have not demonstrated a great deal of promise as permanent cardiac replacements. The increasing number of patients who would be candidates for total heart replacement suggests a large role for a permanent implantable total artificial heart. To that end, the Pennsylvania State University is developing an electric motor-driven total artificial heart; the results with implants in calves are encouraging. In this device, a roller-screw mechanism is used to translate the rotation of a brushless direct-current motor into rectilinear motion of a pusher-plate assembly, which in turn empties the blood sacs. The total artificial heart of the future will function under automatic control without percutaneous leads, and this should provide the patient with a nearly normal life-style. Although further experimental efforts are necessary to prepare the device for clinical trials, the technology to provide a safe and reliable electric blood-pump system is at hand.

Why is fresh-frozen plasma transfused?

A three-part study to determine the reasons for fresh-frozen plasma (FFP) transfusions at hospitals in southeastern Wisconsin was conducted. During a 1-month period, hospital transfusion services reported that patients undergoing open-heart surgery received 42 percent, medical patients 26 percent, noncardiac surgery patients 23 percent, neonatal patients 1 percent, and other patients 7 percent of the FFP transfused. In the second phase of the study, the records of 102 patients receiving FFP during a 1-month period at two teaching hospitals were reviewed. Justification for the FFP transfusion was provided in the hospital chart for only 11 percent of the transfusion episodes, although abnormal results of coagulation studies or signs of hypovolemia were recorded for an additional 51 percent. Frequently, FFP and red cell (RBC) transfusions were given during the same transfusion episode. In the third phase of the study, clinicians completed a questionnaire specifying their "trigger" for prescribing FFP: bleeding (43% of episodes), abnormal coagulation studies (26%), signs/symptoms of hypovolemia (16%), and "other" (15%). They judged that the FFP transfusion was effective in 47 percent of transfusion episodes and ineffective in only 6 percent. These findings indicate that FFP is used mainly as a source of coagulation factor replacement in hospitals served by The Blood Center of Southeastern Wisconsin, that justification for FFP use rarely is provided in patient records, that both FFP and RBCs are frequently transfused together, and that clinicians believe FFP is beneficial for their patients. Educational efforts addressing appropriate use of FFP should be initiated.

Approaches to the artificial heart. Invited speaker.

Over the last two decades, the implantable artificial heart has evolved from an idea to a device capable of completely supporting the circulation for periods now exceeding 5 months. Although initial animal studies were limited by thromboembolism and device breakage, the usual causes of death in experimental animals are now infection, atrioventricular valve obstruction, elastomer bladder calcification, or inadequate cardiac output because of the relatively rapid growth of the young calves. As a result of the bulky nature of the energy converter and the substantial risk of infection with large diameter percutaneous tubes, clinical use of their air-powered artificial hearts will be limited to patients who are awaiting or being prepared for heart transplantation. Artificial hearts with implanted energy converters are being developed for permanent heart replacement. These devices require well-designed, durable mechanical components and sophisticated control systems. Although initial designs centered around thermal engines powered by a completely implantable nuclear energy source, the excessive cost and potential dangers have shifted the focus away from the nuclear system. Several electrically driven artificial hearts, based on samarium-cobalt magnet brushless direct-current motors, are now undergoing bench testing and will be ready for long-term animal studies within 2 years. This research will culminate with the availability of an "off-the-shelf" electrically powered artificial heart for use in patients with a wide range of nonrepairable forms of end-stage heart disease.