[Contrapulsation using the intra-aortic balloon in the postoperative period following extracorporeal circulation (apropos of 8 cases)].
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OBJECTIVE: Investigate the effect of relaxation training/thermal biofeedback on blood circulation in the lower extremities of diabetic subjects. RESEARCH DESIGN AND METHODS: Diabetic subjects (n = 40) aged 17-73 yr were volunteers recruited through the University of Wisconsin-La Crosse, the local ADA Chapter, and a medical clinic. A within-subjects experimental design was used. During phase 1, all subjects used a self-selected relaxation method and recorded toe temperatures daily. During phase 2, subjects were taught a biofeedback-assisted relaxation technique designed to elicit sensations of warmth in the lower extremities and increase circulation and temperature. Subjects relaxed at home with the use of a designated relaxation tape. They measured and recorded toe temperatures. Each phase lasted 4 wk. RESULTS: Toe temperature and blood volume pulse (BVP) data were gathered at the beginning and end of phases 1 and 2. Paired t tests compared the means of temperature percent change scores between 1 and 2. Mean temperature change scores were 8.73% (phase 1) and 31.38% (phase 2) (t = -8.00, df = 39, P less than 0.001). Mean BVP change scores were 2.33% (phase 1) and 22.47% (phase 2) (t = -9.24, df = 35, P less than 0.001). Based on eta squared, 71% of the BVP increase in phase 2 was attributed to the relaxation technique. A multiple regression analysis indicated that none of the other examined variables affected by diabetes were significant predictors of BVP increase. CONCLUSIONS: Data indicate that diabetic patients show significant increases in peripheral blood circulation with this technique. This noninvasive method could serve as an adjunct treatment for limited blood flow in some complications of diabetes.
Radiographic features of the Swan-Ganz catheter and the complications associated with its use are described. Pulmonary infarcts develop subsequent to wedging of the catheter in a peripheral position, failure to deflate the balloon after use, and maintenance for morethan 72 hours. The radiology of the infarct is usually classical in appearance, i.e., pleural-based density which resolves in 14-21 days. The frequency of pulmonary ischemia may BE related to compromise of the venous and collateral arterial circulation in intensive care unit patients in whom the catheter is used.
Congestive heart failure remains a leading cause of morbidity and mortality in the United States, and alternatives to heart transplantation are urgently required. Mechanical circulatory support by ventricular assist devices and total artificial hearts have the potential to provide an alternative to heart transplantation if a small, durable, biocompatible, and totally implantable system is available. In this article, current technologies for mechanical circulatory support by implantable devices are reviewed and the current status and future prospects of the CorAide and MagScrew technologies, which have been developed and tested at the Cleveland Clinic Foundation, are presented.
The Pierce-Donachy ventricular assist device (VAD) was used as an attempted bridge to orthotopic cardiac transplantation in 12 patients aged 13 to 55 years. Ischemic (4 patients), dilated (4 patients), acute viral (1 patient), postpartum (1 patient), and hypertrophic cardiomyopathy (1 patient), along with a failed transplant (1 patient), were the causative factors of end-stage cardiomyopathy in these patients. All patients were candidates for orthotopic cardiac transplantation but sustained refractory cardiogenic shock (cardiac index less than 2 L/min/m2). Left VADs were placed in all patients; 7 also required right VADs. Four patients died of hemorrhagic complications less than 24 hours after VAD insertion. Ventricular assist device stabilization was successful in 8 patients and support ranged from eight hours to 64 days. Seven patients successfully underwent orthotopic cardiac transplantation. One died postoperatively of hemorrhagic complications, 6 were discharged from the hospital, and 1 patient died at 3 months of cytomegalovirus infection. Five patients are long-term survivors. The Pierce-Donachy VAD is an effective means for supporting critically ill patients with end-stage cardiomyopathy and cardiogenic shock before orthotopic cardiac transplantation. Death is related to hemorrhagic, rather than infectious or thromboembolic, complications. Patients successfully stabilized with the VAD can undergo orthotopic cardiac transplantation with acceptable mortality and morbidity rates.
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A specific cannula allowing single site transaortic inflow and outflow cannulation for centrifugal assist devices is described. The cannula is inserted through a straight 18 mm collagen coated Dacron tube anastomosed to the anterior aspect of the ascending aorta. The inflow conduit of the cannula is positioned into the left ventricle through the aortic valve, and the end hole of the outflow conduit is positioned in the ascending aorta. The cannula was evaluated in vivo in 3 adult pigs by the institution of a centrifugal pump for left ventricular support. Optimal flow varied between 5 and 6 L/min and mean aortic pressure between 55 and 70 mm Hg throughout the 3 days of left ventricular support. Recently, we employed this cannula in a patient who was not able to be weaned from cardiopulmonary bypass for the institution of left ventricular support using a centrifugal pump. The cannula provided effective inflow and outflow drainage with an optimal flow of 5.2 L/min throughout the 72 h of support. The patient was successfully weaned from support on the fourth postoperative day. This rational transaortic approach of cannulation using this specific cannula is a refined implantation technique which allows direct left ventricular inflow drainage, reduces the time of implantation, spares left ventricular myocardium, avoids bleeding that is sometimes encountered at other cannulation sites, and avoids compression of the heart by cannulas.
Since 1995, the Baylor Group has been developing a totally implantable NEDO BVAD system. This 10-year program was completed in March 2005, and preparation for clinical trials is underway. This article summarizes the entire 10-year NEDO program and describes the strategy for clinical trials. The project aimed to achieve: (1) dual centrifugal pumps with the ability of full biventricular support, (2) a compact system implantable into small adults, (3) a totally implantable system with transcutaneous energy transmission system (TETS), (4) a durable system with a lifetime of over 5 years, and (5) a system free of thrombus and with minimal hemolysis. The final goals are to complete preclinical system evaluations and commence the clinical trials in the near future. In vitro studies have demonstrated a pump capacity of over 8.5 l/min and an Index of Hemolysis of <0.004 g/100 l. The pump-bearing life expectancy was over 5 years. To date, eight pumps endured in vivo studies of over 3 months without complications, including thromboembolic events. The in vitro endurance studies of eight pumps are longer than 1 year. There were no mechanical malfunctions or pump failure. A stepwise clinical trial is being planned: Step1, a wearable BVAD/VAD will be clinically studied; Step 2, the BVAD/VAD will be implanted intracorporeally without TETS; and, Step 3, a totally implantable system will be clinically evaluated. The NEDO BVAD system has completed preclinical testing. Clinical trial preparation is underway.
The design concept and first in vitro and in vivo results of a long-term implantable ventricular assist device system based on a microaxial blood pump are presented. The blood-immersed parts of the pump consist of a single-stage impeller and a proximally integrated microelectric motor. Both parts are surrounded by a pump housing currently made of polycarbonate to allow visible access to the blood-exposed parts. A titanium inflow cage attached to the tip of the housing is directly implanted into the left ventricular apex. The outflow of the pump is connected to the descending aorta by means of an e-PTFE graft. The overall dimensions of the device are 12 mm in outer diameter and about 50 mm in length. The calculated lifetime of the device is up to 2 years. The system underwent long-term durability tests, hydraulic performance tests, dynamic stability tests, and in vitro hemolysis and thrombogenicity tests. Furthermore, animal tests have been performed in adult Dorset sheep. In a first series, the pump has been placed extracorporeally; in a second series, the pump was completely implanted. Mean duration of the animal experiments of the second series was 31 days (range 8-110 days, n=14); no anticoagulation was administered over the whole test period. Blood data revealed no significant changes in blood cell counts, ionogram, or any other value. No end-organ dysfunction induced by long-term support could be observed, nor did the pathology reveal any evidence of thromboembolic complications.
BACKGROUND: Mammographic density is one of the strongest predictors of breast cancer risk. The mechanism by which breast density increases breast cancer risk is unclear although it has been hypothesized that breast density reflects cumulative exposure to estrogens. METHODS: To evaluate this hypothesis, we conducted a cross-sectional study among 520 postmenopausal women in the Nurses' Health Study that examined the relation between circulating sex hormones and mammographic density. Women were postmenopausal and not taking exogenous hormones at the time of blood collection and mammogram. Percent breast density was measured from digitized mammograms using a computer-assisted method. Circulating estrone, estradiol, androstenedione, testosterone, DHEA, DHEA sulfate, sex hormone-binding globulin, progesterone, and prolactin were measured in plasma. RESULTS: In contrast to the prior hypothesis, circulating estrogens were inversely related to percent mammographic density. The mean percent mammographic density was 25.6% among women in the lowest quartile of circulating estradiol compared with 14.4% among women in the highest quartile [Spearman correlation (r) = -0.22, P < 0.0001]. Circulating estrogens alone explained 1% to 5% of the variation of mammographic density. Body mass index was positively associated with circulating estradiol levels (r = 0.45, P < 0.0001) and inversely related to percent mammographic density (r = -0.51, P < 0.0001). After adjustment for body mass index, there was no association between estradiol and breast density (r = 0.01, P = 0.81). Likewise, there was no relation between the other sex hormones measured or prolactin and mammographic density after adjustment for body mass index. CONCLUSION: These findings indicate that in postmenopausal women, mammographic density is independent of circulating sex hormone levels.
Forty-one patients, distributed among four centers, had left (33 patients), right (five), or bilateral (three) temporary ventricular assistance with textured (24) or smooth (17) surfaced diaphragm pumps, during an evaluation supported by the National Institutes of Health. Cardiac failure had occurred in 39 postoperative patients (after aorta-coronary bypass [23], valve replacement [four], both [nine], or other [three]), with total cardiopulmonary bypass time mean 306 minutes (range 69 to 600). Two patients had cardiomyopathy. Death of 35 nonsurvivors was due to myocardial necrosis (14), hemorrhage (nine), cerebrovascular accidents (three), infection (three), and other (six). Mean duration of support in all patients was 62 hours. In 16 patients (40%) whose condition improved, cardiac assist duration was mean 127 hours (range 48 to 264), compared with mean 19 hours (range 1 to 120) in 25 who did not. Of 17 patients in whom duration of support exceeded 72 hours, 15 (88%) improved, 11 were weaned, and six survived long term. Tissue examination (in 33 patients) by biopsy at pump implantation or autopsy revealed coagulation or contraction band myocyte necrosis, with or without hemorrhage, in 26 patients; of these, 10 improved and six were long-term survivors. Pump-related complications (two) included pulmonary embolism, most likely related to a cannulation site thrombus, and an aortic cannulation site infection in one patient each. This study suggests that mechanical cardiac assist may be accomplished with a low complication rate; should not necessarily be denied to patients with existing necrosis, because myocardial necrosis does not preclude improvement or survival; and frequently leads to functional myocardial recovery if patients survive early noncardiac complications, often the result of long duration of cardiopulmonary bypass.
OBJECT: We conducted a prospective study to determine whether or not combined emergency percutaneous cardiopulmonary support (PCPS) and coronary reperfusion treatment are useful for acute myocardial infarction (MI) patients with unsynchronized electric shock-resistive ventricular fibrillation (VF). PATIENTS AND METHODS: Thirty-two acute MI patients who lapsed into the refractory VF were entered into the study. Group 1 consisted of 19 patients with VF outside the hospital, and Group 2 consisted of 13 patients with VF immediately after arrival at the hospital. The primary endpoint was successful reperfusion, return of spontaneous circulation and good recovery without neurologic disability. RESULTS: The infarct-related arteries showed a significant difference between Groups 1 and 2. However, the two groups had similar rates of successful reperfusion (84.6% vs 94.7%, respectively) and return of spontaneous circulation (89.5% vs 84.6%, respectively). The rates of good recovery were similarly low in both groups (5.3% vs 15.4%, respectively). CONCLUSION: Combined emergency PCPS and reperfusion treatment produced high return of spontaneous circulation, however the neurologic outcome was low.
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Since January 1985, the Heart Transplant Program at Washington University Medical Center, St. Louis, has performed 89 heart transplantations in 86 patients. Twenty patients (23%) have required preoperative mechanical support of circulation or respiration prior to transplantation. The Bio-Medicus centrifugal pump (Bio-Pump) formed the basis of our circulatory support system during the period of this report. Nine patients were placed on the Bio-Pump with the intention of bridging them to transplantation. Six patients required left ventricular assistance; in 2, the device was inserted because they could not be weaned from cardiopulmonary bypass. Two patients required biventricular assistance, 1 because she could not be weaned from cardiopulmonary bypass at the end of a cardiac operation. Extracorporeal membrane oxygenation was necessary in 1 patient for right ventricular decompensation and cardiac arrest four hours after orthotopic cardiac transplantation. One of these 9 patients died on circulatory support, and in another, a complication developed that precluded transplantation. The remaining 7 patients (78%) underwent a successful transplant procedure after an average of 1.6 days of circulatory support (range, 0.5 to three days), and all are long-term survivors of transplantation. There has been 1 late death at 17 months from a cerebrovascular hemorrhage. In summary, the centrifugal pump provides excellent short-term circulatory support for individuals who would otherwise die before cardiac transplantation.
Between July 1987 and March 1989, 11 patients underwent left ventricular support with the Novacor left ventricular assist system irrespective of apparent degree of right ventricular failure. The first 2 patients died of multisystem organ failure while on support. All the remaining patients survived the support period, and actuarial survival after transplantation was 100% at 6 months and 89% at 1 year. In no patient did bacterial infection develop during support or after transplantation. Right ventricular ejection fraction before implantation of the left ventricular assist system was lower than 15% in 6 of 8 patients, yet it increased twofold during left ventricular support. The need for excessive inotropic support (2 patients) or temporary (four days) mechanical right ventricular support (2 patients) while on the left ventricular support system appeared to be related to elevated pulmonary vascular resistance during support in association with large preimplantation ventricular volumes. It appears that even patients with compromised right ventricular performance can be supported long term with a left ventricular assist device. Patients with elevated pulmonary vascular resistance may require temporary right ventricular support.
BACKGROUND: To assess the relative efficacy of cardiac transplantation after mechanical circulatory support with a variety of support systems, we analyzed our consecutive series of patients who had and did not have mechanical support before transplantation. METHODS: A review of 209 patients undergoing cardiac transplantation from 1984 to May 1995 was performed. Group 1 consisted of 110 patients who were maintained on oral medications while awaiting transplantation, and group 2 consisted of 60 patients who required intravenous inotropic support. Group 3 included 39 patients who had transplantation after mechanical circulatory support for cardiogenic shock. The indication for device implantation was acute onset of cardiogenic shock in 38 patients and deterioration while awaiting transplantation in 1 patient. The support systems were an intraaortic balloon pump in 13 (subgroup 3A), a ventricular assist device in 7 (subgroup 3B), and a total artificial heart in 19 patients (subgroup 3C). RESULTS: After transplantation, infection was more common in group 3 (56%) than in group 1 (28%) or group 2 (32%) (p = 0.005). Survival to discharge was lower for group 3 (71.7%) than for group 1 (90.9%) or 2 (88.3%) (p = 0.009). For mechanically supported patients, survival to discharge was 84.6% in subgroup 3A, 71.4% in subgroup 3B, and 63.1% in subgroup 3C (p = not significant). CONCLUSIONS: Transplantation after mechanical support offers acceptable results in this group of patients for whom the only alternative is certain death. Patient selection and perioperative management remain the challenge to improving these results.
Donor heart and ventricular assist device excision can be extremely difficult at the time of heart transplant. We present a strategy of hypothermic circulatory arrest established with ventricular assist device cannulas for difficult heart transplants. The device inlet or outlet cannulas already in place, or both, are used to complement the safe cannulation sites available. This approach permits controlled excision of the recipient heart and device, easy access to convert to standard ascending aorta and bicaval cannulation, and minimizes the donor graft anoxia time. Two case reports are presented.
Mechanical ventricular assist with a centrifugal pump with or without anticoagulation for an extended period has been used in 41 patients with postcardiotomy ventricular failure. Left ventricular, right ventricular, and biventricular assist were required. The efficacy and safety of mechanical ventricular assist have been documented. Marked improvement in survival has been observed in the more recent part of this series, and is attributed to earlier employment of the assist device, maintenance of better flow rates near physiological levels, and use of biventricular assist to provide effective circulatory support. Mechanical ventricular assist is easy to use, and the conversion from ordinary cardiopulmonary bypass is also easy. Therefore, mechanical assist provides a very effective means of temporary circulatory assist.