Copulsation balloon for right ventricular assistance: preliminary trials.

BACKGROUND: Options for management of acute right ventricular (RV) failure are limited. This report describes preliminary testing of a temporary RV assist device that acts by direct compression of the RV. The system comprises a pancake-shaped silicone balloon (5 cm diameter) connected to a drive console that delivers a 65-mL pneumatic pulse during cardiac systole. METHODS AND RESULTS: Initial in vivo tests were performed on 6 pigs (weight, 41+/-4 kg). RV wall motion and stroke volume were monitored via transesophageal echocardiography. Acute RV failure was created by graded right coronary ligation, which yielded a 63% reduction in RV stroke volume (39.9+/-8.2 to 14.7+/-1.9 mL; P<0.002). We secured the balloon over the RV free wall by attaching it to the edges of the opened pericardium. The sternum was then reapproximated, and data were collected with the device off and on (every beat). Device placement had no deleterious effect on RV function. Balloon activation returned RV stroke volumes to normal (37.8+/-9.2 mL) and increased mean pulmonary artery pressures from 13+/-2 to 16+/-3 mm Hg (P<0.01). RV compression did not induce or exacerbate tricuspid regurgitation. Mean aortic pressure improved from postinfarction levels but did not return to normal. CONCLUSIONS: We conclude that the pulmonary circulation can be supported in the short term via cardiac compression and that balloon copulsation techniques for short-term RV failure should be tested in long-term models.

A model that predicts morbidity and mortality after coronary artery bypass graft surgery.

OBJECTIVES: This study was performed to develop a method for identifying patients at increased risk for morbidity or mortality after coronary artery bypass graft surgery. BACKGROUND: Postoperative morbidity is more common than mortality and is important because of its relation to cost. METHODS: Univariate and forward stepwise logistic regression analysis was used to retrospectively analyze a group of 1,567 consecutive patients who underwent bypass surgery between July 1991 and December 1992. We developed a model that predicted postoperative morbidity or mortality, or both, which was then prospectively validated in a group of 1,235 consecutive patients operated on between January 1993 and April 1994. A clinical risk score was derived from the model to simplify utilization of the data. RESULTS: The following factors, listed in decreasing order of significance, were found to be significant independent predictors: cardiogenic shock, emergency operation, catheterization-induced coronary artery closure, severe left ventricular dysfunction, increasing age, cardiomegaly, peripheral vascular disease, chronic renal insufficiency, diabetes mellitus, low body mass index, female gender, reoperation, anemia, cerebrovascular disease, chronic obstructive pulmonary disease, renal dysfunction, low albumin, elevated blood urea nitrogen, congestive heart failure and atrial arrhythmias. Observed morbidity and mortality for the validation group fell within the 95% confidence interval of that predicted by the model. Costs were closely related to the incidence of postoperative morbidity. CONCLUSIONS: Analysis of preoperative patient variables can predict patients at increased risk for morbidity or mortality, or both, after bypass surgery. Increased morbidity results in higher costs. Different strategies for high and low risk patients should be used in cost reduction efforts.

Transient ischemia does not limit subsequent ischemic regional dysfunction in humans: a transesophageal echocardiographic study during minimally invasive coronary artery bypass surgery.

OBJECTIVES: This study sought to assess the effects of sequential coronary artery occlusion during minimally invasive coronary artery bypass graft surgery (CABG) on hemodynamic variables and left ventricular systolic function by means of transesophageal echocardiography (TEE). BACKGROUND: Clinical and experimental studies suggest a protective effect of ischemic preconditioning in patients with acute coronary syndromes. However, the effect of repetitive myocardial ischemia on myocardial mechanical function in humans is not completely understood. METHODS: Seventeen patients with left anterior descending coronary artery (LAD) stenosis > or =70% and normal rest left ventricular systolic function referred for minimally invasive CABG underwent intraoperative TEE for assessment of regional left ventricular wall motion and measurement of hemodynamic variables at baseline (baseline 1), during a 5-min coronary occlusion (occlusion 1), after a 5-min reperfusion period (baseline 2) and a during a second coronary occlusion during bypass anastomosis (occlusion 2). RESULTS: Left ventricular wall motion score (LVWMS) increased significantly from baseline (16.0) to occlusion 1 (21.4+/-3.1 [mean +/- SD], p < 0.05) and occlusion 2 (21.8+/-3.1, p < 0.05). No difference in LVWMS was noted between occlusions 1 and 2. Pulmonary artery systolic pressure increased significantly from baseline (25+/-6 mm Hg) to occlusion 1 (32+/-7 mm Hg, p < 0.05) and occlusion 2 (33+/-6 mm Hg, p < 0.05). Pulmonary artery diastolic pressure also increased significantly from baseline (12+/-4 mm Hg) to occlusion 1 (16+/-4 mm Hg, p < 0.05) and occlusion 2 (16+/-4 mm Hg, p < 0.05). No significant differences in pulmonary artery pressures were noted between occlusions 1 and 2. CONCLUSIONS: Ischemic dysfunction was precipitated by the 5-min LAD occlusion, as shown by the increase in LVWMS and pulmonary artery pressure. However, a 5-min coronary occlusion and the resulting ischemia do not alter regional left ventricular systolic function during subsequent ischemia in humans.

Aortic valve replacement and combined aortic valve replacement and coronary artery bypass grafting: predicting high risk groups.

To determine which groups of patients are at highest risk for operative or late mortality, 259 consecutive patients who underwent operation between 1978 and 1984 were studied; 170 underwent aortic valve replacement and 89 underwent aortic valve replacement combined with coronary artery bypass grafting. Multivariate analysis of risk factors selected emergency operation and patient age older than 70 years as the strongest predictors for operative death. Although patients having aortic valve replacement and coronary artery bypass grafting had a higher operative mortality rate (13.5 versus 3.5%), the combined operation had no independent predictive effect on early or late results. At a mean follow-up time of 48 months after surgery, 72% of the survivors of operation were living, 10% were lost to follow-up and 18% were dead. Seventy-seven percent of long-term survivors were in New York Heart Association functional class I or II. The incidence of thromboembolism, paravalvular leak, bacterial endocarditis and hemorrhage each occurred at a rate of less than 1% per patient-year. The factors associated with late death were preoperative age, male sex, left ventricular end-diastolic pressure, cardiac index and functional class. Despite an increase in operative mortality, patients undergoing emergency operation were not at higher risk of late death. Operative mortality is concentrated among several high risk groups. For patients undergoing elective operation, operative mortality is low, especially if the patient is less than 70 years old. Late results are good for all groups of patients undergoing operation, including those who are at greater risk of dying at operation.

Mechanical analysis of midline sternotomy wound closure.

OBJECTIVE: Unstable median sternotomy closure can lead to postoperative morbidity. This study tests the hypothesis that separation of the sternotomy site occurs when physiologic forces act on the closure. METHODS: Median sternotomy was performed in 4 human cadavers (2 male) and closed with 7 interrupted stainless steel wires. The chest wall was instrumented to apply 4 types of distracting force: (1) lateral, (2) anterior-posterior, (3) rostral-caudal, and (4) a simulated Valsalva force. Forces were applied in each direction and were limited to physiologic levels (< 400 N). Four sets of sonomicrometry crystals were placed equidistantly along the sternum to measure separation at the closure site. RESULTS: Sternal separation occurred as a result of the wires cutting through the bone. Less force was needed to achieve 2.0-mm distraction in the lateral direction (220 +/- 40 N) than in the anterior-posterior (263 +/- 74 N) and rostral-caudal (325 +/- 30 N) directions. More separation occurred at the lower end of the sternum than the upper. During lateral distraction, xiphoid and manubrial displacement averaged 1.85 +/- 0.14 and 0.35 +/- 0.12 mm, respectively. Anterior-posterior distraction caused 1.99 +/- 0.04-mm xiphoid displacement and 0.26 +/- 0.12-mm manubrial displacement. During a simulated Valsalva force, more separation occurred in the lateral (2.14 +/- 0.11 mm) than in the anterior-posterior (0.46 +/- 0.29 mm) or rostral-caudal (0.25 +/- 0.15 mm) directions. CONCLUSIONS: These data suggest that sternal dehiscence can occur under physiologic loads and that improved sternal stability may be readily achieved via mechanical reinforcement near the xiphoid. Closure techniques designed to minimize wire migration into the sternum should also be developed.

Protection of the immature myocardium. An experimental evaluation of topical cooling, single-dose, and multiple-dose administration of St. Thomas' Hospital cardioplegic solution.

Low cardiac output in infants after cardiac operations continues to be a problem, yet little experimental work has been done to evaluate the various methods of protecting the immature myocardium. In this study, we have used an isolated working heart model to test three methods of myocardial protection in 3- to 4-week-old rabbit hearts: (1) topical cooling, (2) single-dose cardioplegia plus topical cooling, and (3) multiple-dose cardioplegia plus topical cooling. Myocardial temperature was maintained at 10 degrees C during ischemia, and St. Thomas' Hospital solution was used for cardioplegia. Sets of 18 hearts were subjected to 60, 90, or 120 minutes of ischemia, and within each set six hearts were protected by all three methods. After 90 and 120 minutes of ischemia, the percent recovery of aortic flow (expressed as mean +/- standard error of the mean) was lower in hearts protected with multiple-dose cardioplegia plus topical cooling (61.5% +/- 4.8%, 50.7% +/- 14.2%) than in those protected with topical cooling (92.4% +/- 5.7%, 94.3% +/- 12.8%) or single-dose cardioplegia plus topical cooling (86.4% +/- 5.3%, 90.2 +/- 3.6%). However, adenosine triphosphate, creatine phosphate, and glycogen levels were adequately preserved in all groups. Both topical cooling and single-dose cardioplegia provide effective protection for the immature rabbit heart during ischemia, but multiple-dose cardioplegia plus topical cooling results in inadequate preservation of hemodynamic function, despite adequate preservation of myocardial high-energy phosphate stores.

Pressure support ventilation with a simplified ventilatory support system administered with a nasal mask in patients with respiratory failure.

Thirty-one consecutive patients with respiratory failure in whom treatment with intubation and mechanical ventilation was being strongly considered received alternative ventilatory support by means of a BiPAP ventilatory support system and nasal mask. Laboratory measurements and physical findings were documented before and 1 h after initiation of support. This support improved patient comfort, slowed respiratory rate, and improved oxygenation. Support lasted from 2 h to six days. Seventy-six percent (22/29) of patients recovered from this episode of respiratory failure, avoiding alternative mechanical ventilatory support. There were no complications associated with aspiration, gastric distention, or acute separation from support.

Experimental studies on heterotopic lung transplantation during temporary pulmonary insufficiency.

Survival from reversible forms of severe pulmonary insufficiency remains dismal despite the development of artificial oxygenators. We hypothesized that an intraabdominal heterotopic lung could help maintain adequate oxygenation during acute pulmonary insufficiency. Five mongrel dogs underwent an acute heterotopic lung transplant (HLT). The left atrial cuff was anastomosed to the inferior vena cava, and the left pulmonary artery was anastomosed to the abdominal aorta. The trachea was exteriorized, intubated, and ventilated with a volume-controlled ventilator. Ventilation to the native lungs was discontinued. The heterotopic lung was then ventilated at a rate of 20/min, tidal volume of 15 ml/kg, and inspired concentration (FIO2) of 50 percent. Partial pressure of oxygen (PO2) and mixed venous oxygen saturation (SvO2) were maintained at 53 +/- 5.2 mm Hg and 71 +/- 12 percent, respectively. Flow through the HLT was approximately 20 percent of the systemic cardiac output and did not vary with changes in FIO2, respiratory rate, or positive end-expiratory pressure (PEEP). Four separate animals underwent HLT and were studied 2 to 3 days later. The FIO2 was reduced in the native lungs to 10 percent until SaO2 was less than 90 percent. The HLT was then ventilated at a tidal volume of 300 ml, an FIO2 of 50 percent, and a respiratory rate of 10. Arterial PO2 increased from 62 +/- 4 mm Hg to 75 +/- 2 mm Hg, and SvO2 increased from 75 +/- 2 percent to 82 +/- 3 percent (p < 0.05). Flow through the HLT increased slightly to 27 percent of the systemic cardiac output. We conclude that a HLT can augment oxygenation after induction of moderate hypoxemia, but cannot serve as the sole source for gas exchange because flow through the HLT is limited to less than 30 percent of the cardiac output.

The immature and the mature myocardium. Responses to multidose crystalloid cardioplegia.

This study was designed to determine whether multidose St. Thomas' Hospital cardioplegic solution is as effective for preservation of the immature myocardium during ischemia as it is for the mature myocardium. An isolated working heart model was used. Sets of six hearts from immature (3 to 4 weeks, 500 gm) and mature (24 weeks, 2 kg) rabbits were subjected to 60, 90, or 120 minutes of ischemia. Myocardial protection consisted of infusion of cardioplegic solution every 30 minutes at 4 degrees C in a dose of 10 ml/kg of animal weight and maintenance of hypothermia at 10 degrees C by immersion in a cold saline bath. The percent recovery of preischemic aortic flow was lower in the immature than the mature hearts after 90 minutes (60.3% +/- 7.4% versus 101.8% +/- 4.3%) and after 120 minutes (57.4% +/- 10.6% versus 91.1% +/- 13.6%) of ischemia (results expressed as mean value +/- standard error of the mean, p less than 0.05). There were no differences between the mature and the immature hearts in the recovery of heart rate, left atrial pressure, mean aortic pressure, or glycogen stores. Adenosine triphosphate levels measured at the end of the experiment were not different from control in the immature hearts subjected to 60 or 90 minutes of ischemia, but did decline after 120 minutes of ischemia (18.5 +/- 0.8, 16.9 +/- 1.3, 16.6 +/- 0.6 versus 12.3 +/- 1.8 mumol/gm dry weight, p less than 0.05). Adenosine triphosphate levels in the mature hearts were lower than control in hearts subjected to 60, 90, and 120 minutes of ischemia (18.0 +/- 1.2 versus 13.6 +/- 1.1, 12.8 +/- 0.9, 13.7 +/- 1.5 mumol/gm dry weight, p less than 0.05). Multidose St. Thomas' Hospital cardioplegia does not provide adequate preservation of hemodynamic function in the immature rabbit heart, even though myocardial high-energy stores are well preserved. Additional work is necessary to clarify the mechanism of this finding and to develop appropriate methods for protection of the immature myocardium.

Genetic evolutionary staging of early non-small cell lung cancer: the P53 --> HER-2/NEU --> ras sequence.

INTRODUCTION: The sequence of genetic evolutionary abnormalities that have occurred in a given lung cancer tumor before tumor sampling can be inferred from patterns of intracellular co-occurrence of these abnormalities in tumor cell subpopulations at the time of sampling. The same evolutionary sequences that are present within each lung cancer were evident in intertumor comparisons. METHODS: Correlated cell by cell measurements of cell DNA content, p53, Her-2/neu, and ras proteins were obtained by multiparameter flow cytometry on 46 surgically resected stage I-III primary non-small cell lung cancers. Early evolutionary changes were identified by the fact that they could appear alone in individual cells. Later appearing abnormalities were identified by the fact that they were accompanied by early abnormalities in the same cells. Patients were followed prospectively. Evolutionary patterns observed in individual tumors were correlated with subsequent clinical outcome of patients undergoing surgical resection. RESULTS: Three common patterns were identified: (I) a diploid DNA pathway consisting of the sequence p53 overexpression --> Her-2/neu overexpression --> ras overexpression, (II) an aneuploid DNA pathway with the same p53 --> Her-2/neu --> ras sequence, and (III) a pathway in which none of the intracellular protein measurements made here were abnormal. Fourteen tumors recurred after 11.5 months' median study time. Nine of 12 recurrences in pathways I and II occurred in patients whose tumors were far advanced along these molecular genetic pathways. CONCLUSIONS: Multiparameter cell-based genetic evolutionary studies may be a promising approach for identifying patients with stage I-III non-small cell lung cancer at high risk for recurrence.

Chronic counterpulsation with descending thoracic aortomyoplasty improved cardiac function in animals with heart failure.

Descending thoracic aortomyoplasty uses latissimus dorsi muscle for extraaortic diastolic counterpulsation. We hypothesized that descending thoracic aortomyoplasty could improve ventricular function in dogs (n = 5) with heart failure. The left latissimus dorsi muscle was wrapped around the descending aorta and conditioned for 4 weeks with a burst stimulator (five pulses, 33 Hz, 28 bursts/min). Heart failure was induced by rapid ventricular pacing after conditioning. Left ventricular volume was measured with a conductance catheter. Left ventricular and aortic pressures were measured with a micromanometer. Mean diastolic blood pressure, endocardial viability ratio, left ventricular peak pressure, left ventricular end-diastolic pressure, stroke work, isovolumic relaxation time constant, and the end-systolic pressure volume relation were measured at baseline (after heart failure) and with the descending thoracic aortomyoplasty stimulated at 1:1. Contraction of the descending thoracic aortomyoplasty augmented mean diastolic blood pressure (62 +/- 4 to 71 +/- 3 mm Hg) and endocardial viability ratio (1.0 +/- 0.30 to 1.5 +/- 0.13) (p < 0.05). Left ventricular peak pressure (98 +/- 4 to 88 +/- 3 mm Hg), left ventricular end-diastolic pressure (19 +/- 4 to 14 +/- 4 mm Hg), and stroke work (1048 +/- 124 to 743 +/- 80 mm Hg.cm3) (p < 0.05) were reduced. The end-systolic pressure volume relation increased with descending thoracic aortomyoplasty stimulation (3.7 +/- 0.7 to 4.5 +/- 0.8 mm Hg/mL), and the isovolumic diastolic relaxation time constant significantly decreased (54 +/- 6 to 49 +/- 7 msec) (p < 0.05). We conclude that descending thoracic aortomyoplasty can provide diastolic counterpulsation and reduce stroke work in animals with heart failure.(ABSTRACT TRUNCATED AT 250 WORDS)

Static left latissimus dorsi cardiomyoplasty: effect on left ventricular function.

When the latissimus dorsi is used for ventricular augmentation in cardiomyoplasty, a delay of several weeks occurs before the muscle revascularizes, adheres to the heart, and is transformed to fatigue-resistant status. This study analyzes the effect of static (unstimulated) cardiomyoplasty on left ventricular function. Four mongrel dogs underwent staged left latissimus dorsi cardiomyoplasty. Left ventricular pressure was measured with a micromanometer catheter. Left ventricular volume was measured by sonomicrometry. Cardiac output, heart rate, preload recruitable stroke work, maximum elastance, left ventricular end-diastolic volume, left ventricular end-diastolic pressure, stroke work, and the diastolic relaxation constant were measured before and immediately after cardiomyoplasty with the myoplasty static. Results, expressed as mean +/- standard error of the mean, showed no significant differences in indexes of systolic function (stroke work, 1017 +/- 223 gm.cm to 984 +/- 403 gm.cm; preload recruitable stroke work, 110 +/- 13 gm.cm/cm3 to 115 +/- 19.8 gm.cm/cm3; maximum elastance, 10.38 +/- 5.6 mm Hg/ml to 13.59 +/- 6.5 mm Hg/ml; cardiac output 4.51 +/- 0.43 L/min to 4.21 +/- 0.34 L/min) or diastolic function (left ventricular end-diastolic volume, 21 +/- 5.2 ml to 20 +/- 5.3 ml; left ventricular end-diastolic pressure, 13 +/- 3.5 mm Hg to 15 +/- 3 mm Hg; diastolic relaxation constant 42.8 +/- 5.2 msec to 42.5 +/- 4.5 msec). Heart rate also remained unchanged (131 +/- 8.9 beats/min to 140 +/- 9.8 beats/min). The static (unstimulated) left latissimus dorsi cardioplasty can be done with little effect on left ventricular systolic or diastolic function in the normal canine heart.

Heterotopic lung transplantation: temporary biologic support for reversible pulmonary insufficiency.

BACKGROUND: The mortality rate resulting from adult respiratory distress syndrome in patients awaiting orthotopic lung transplantation remains high. Providing an "extra" lung may provide a potential solution to support a failing pulmonary system. We hypothesized that using a heterotopic lung transplant can correct hypoxemia and hypercarbia in both the short term and the long term. METHODS: Seven mongrel dogs underwent transplantation of a left lung into the abdomen. Anastomosis between the left atrial cuff and the pulmonary artery of the donor lungs was accomplished to systemic venous and arterial circulations, respectively. The main stem bronchus was exteriorized, intubated, and ventilated. Immunosuppression consisted of prednisone and azathioprine both preoperatively and postoperatively. Progressive levels of systemic hypoxemia and hypercarbia were induced. The heterotopic lung transplant augmented oxygenation with a tidal volume of 300 cc, a fraction of inspired oxygen of 50%, and a respiratory rate of 10 and then 20 breaths/min. Four animals were studied again at 48 hours. Flow through the heterotopic lung transplant ranged from 25% to 33% of the cardiac output. RESULTS: Statistically significant improvements were seen in both systemic oxygenation and ventilation in the short-term experiment. The systemic oxygen pressure improved from 37 +/- 3 mm Hg to 67 +/- 5 mm Hg after ventilation of the heterotopic lung transplant, and the carbon dioxide pressure improved from 56 +/- 1 mm Hg to 43 +/- 2 mm Hg. At 48 hours an improvement in oxygen pressure was noted after ventilation of the heterotopic lung transplant, from 42 +/- 3 mm Hg to 56 +/- 2 mm Hg and an improvement in systemic carbon dioxide pressure was noted after ventilation of the heterotopic lung transplant from 57 +/- 7 mm Hg to 46 +/- 4 mm Hg. CONCLUSIONS: The heterotopic lung transplant was able to provide effective gas exchange and support both oxygenation and ventilation after the induction of acute hypoxemia or hypercarbia, both immediately and at 48 hours after implantation. The heterotopic lung transplant may serve as an alternative mode of temporary support for those with acute respiratory insufficiency or as a bridge for those awaiting orthotopic lung transplantation.

Surgical therapy for congestive heart failure: indications for transplantation versus cardiomyoplasty.

Heart transplantation is the procedure of choice for patients with severe congestive heart failure, but many patients are not candidates because of associated medical problems and the lack of donor hearts. Since 1988 we have performed 36 heart transplantations. One and 2-year actuarial survival rates have been 82% and 73%. Sixteen patients who were not candidates for heart transplantation have undergone cardiomyoplasty, a procedure in which the left latissimus dorsi is transposed to the myocardium and paced synchronously with the heart to augment cardiac function. The average age was 55 years (range, 39 to 65 years). Preoperative left and right ejection fractions were 24.9% +/- 2.1% and 43% +/- 4.5%. Eleven patients were in the New York Heart Association class IV, and five patients were in class III. Four operative deaths occurred, and three additional deaths occurred within 6 months of surgery. Nine patients became long-term survivors, and seven of nine patients are alive at a mean follow-up of 29 months. All patients are in New York Heart Association class I or II. In long-term survivors, mean left ventricular ejection fraction increased from 24.9% +/- 2.1% to 31.8% +/- 3.5% (p less than 0.01). All but one of the operative and early deaths occurred in patients with biventricular failure (n = 6). One operative death and no early deaths occurred in patients with normal right ventricular ejection fraction. This initial experience suggests that cardiomyoplasty may be helpful for heart failure patients with preserved right ventricular function, but heart transplantation should be the therapy of choice for biventricular failure.

Ergometric studies of untrained skeletal muscle demonstrate feasibility of muscle-powered cardiac assistance.

The feasibility of biomechanical circulatory assistance hinges on the capacity of skeletal muscle to generate significant hemodynamic work. This study quantifies linear contractile energetics via a customized hydraulic ergometer. Six normal canine latissimus dorsi (LD) muscles (200 +/- 25 g) were evaluated. The muscles were not mobilized; thereby their collateral circulation was preserved. The humeral insertion of the LD muscle was transected and connected to the ergometer. Preload was adjusted to return the LD muscle to its in situ length, and one pulse train was delivered every second. The resulting contractions generated peak pressures of 134 +/- 17 mmHg with mean pressures during shortening of 102 +/- 12 mmHg. Flow rates averaged 5.45 +/- 0.26 l/min. Mechanical work output was calculated at 1.14 +/- 0.18 J/contraction, yielding an average power production of 4.57 +/- 0.72 W during shortening. Continuous LD output power, measured at 5.76 +/- 0.90 mW/g, compares favorably with the 3.48 mW/g typically generated by a 350-g human heart. We therefore conclude that skeletal muscle of sufficient mass can sustain work rates suitable for cardiac assistance despite the 50% power losses typically experienced after muscle training.

A permanent prosthesis for converting in situ muscle contractions into hydraulic power for cardiac assist.

The key to utilizing muscle power for circulatory support lies with the development of a practical scheme by which contractile energy may be collected and efficiently delivered to the bloodstream. This work describes initial in vitro testing of a prototype muscle energy converter (MEC) designed to transform the power of in situ muscle contractions into hydraulic form. The MEC resembles a simple piston pump and is designed for implant beneath the humeral insertion of the latissimus dorsi muscle. Bench tests were conducted to measure component function and to characterize device performance under various hydraulic loads. Under simulated muscle-pull conditions, MEC energy transfer capacity was found to be 170 mJ/stroke while operating at peak efficiencies (i.e., > 98% of input power converted into hydraulic energy and preload work). Transfer efficiencies dropped from 96 to 38% as mean generated pressures increased from 23 to 36 N/cm2 due to metal bellows flexion. These results demonstrate that a significant amount of contractile energy can be efficiently transformed to hydraulic power via this mechanism.

Method for measuring long-term function of muscle-powered implants via radiotelemetry.

Long-term remote monitoring of muscle-powered implants has been made possible with development of an adjustable workload that can be remotely monitored to assess device function. This technique obviates the need for percutaneous access lines and allows test animals to remain untethered, eliminating deleterious effects caused by infection, sedation, or animal stress. Hardware components include a latex bladder fixed within a hermetically sealed canister, multichannel implantable telemetry unit, and subcutaneous access port (for pressure charge adjustment). To validate this method, in vitro tests were performed by using a third-generation muscle energy converter designed to function as an implantable hydraulic pump. Two channels of telemetered pressure data were collected and used to calculate six indexes of device function. Calculated parameters were then compared with measured values to determine accuracy. Correlation between measured and calculated parameters was high in all instances, with most estimates yielding errors of <3%. These results demonstrate the utility of this approach and support its use as a means to monitor muscle-powered devices during long-term animal trials.

A muscle-powered energy delivery system and means for chronic in vivo testing.

Electrically stimulated skeletal muscle represents a potentially unlimited source of energy for the actuation of motor prostheses. Devices to harvest and deliver contractile power have proven mechanically feasible, but long-term efficacy has not been demonstrated. This report describes recent refinements in muscle energy converter (MEC) design and details the development of an implantable afterload chamber (IAC) designed to facilitate implant testing. The IAC comprises a fluid-filled bladder housed within a titanium cylinder that connects directly to the MEC. A vascular access port allows percutaneous measurement and adjustment of air pressure within the housing and provides a means both to monitor MEC function and to control hydraulic loading conditions. Data from in vitro tests show that IAC pressure mirrors changes in MEC-piston displacement over a wide range of actuation speeds and stroke lengths. Stroke lengths and actuation forces calculated from IAC pressure readings were typically found to be within 5% of measured values. This testing scheme may yield important information in regard to the ability to harness energy from in situ muscle over prolonged periods.

Diuresis in hemodynamically compromised patients: continuous furosemide infusion.

We have used continuous infusion of furosemide to achieve diuresis in patients who are stable but hemodynamically compromised after heart operations. With a loading dose of 20 mg and a continuous infusion of 4 to 10 mg of furosemide per hour, mean 24-hour urine output was 5.7 L (238 +/- 65 mL/h). Potassium replacement was 115 +/- 20 mmol [115 +/- 20 mEq/L]. Cardiac index, central venous pressure, and diastolic pulmonary artery pressure did not change significantly, even though hemodynamic support was decreased in each patient. Continuous furosemide infusion is a simple, effective, and reliable method to achieve diuresis in select patients.

Successful left ventricular assist after a first and second heart operation.

Progressive coronary artery disease and recurrent symptoms developed in a 57-year-old man. Nine years earlier he had undergone coronary artery bypass grafting and was supported with a centrifugal left ventricular assist device. He underwent redo coronary artery bypass and again required left ventricular assistance. The patient recovered and was discharged on the 15th postoperative day. He is doing well 1 year after operation and has good left ventricular function.