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E Kreuzer

Publications and source records attributed to E Kreuzer.

At least 37 records · Page 2Linked to original sources
PubMed1999

Coronary risk factor management for the prevention and treatment of graft vessel disease in heart transplant patients.

There is increasing evidence that atherogenic risk factors largely contribute to the pathogenesis of graft vessel disease (GVD) after heart transplantation. Initial endothelial damage of the transplant heart derives from reperfusion ischemia during operation, repeated infections, and rejection episodes. Immunosuppressive medication considerably increases low density lipoprotein (LDL) cholesterol, lipoprotein(a), and fibrinogen blood levels, which in turn further damage the endothelium of the graft coronaries. Probably, this interplay of immunological and atherogenic factors accounts for the rapid development of GVD and its poor prognosis. The rapidity of the disease process makes it necessary to eliminate important risk factors as early and as efficiently as possible. Therefore, we studied whether heart transplant patients could benefit from a combined treatment of statins and apheresis heparin extracorporeal LDL/fibrinogen precipitation (HELP), which has already been shown to be beneficial for the treatment of advanced coronary artery disease. Such a combined treatment allows simultaneous and drastic reduction of LDL, lipoprotein(a), and fibrinogen blood levels and significantly prevented GVD. Moreover, it did not affect the prevention of rejections and infections, respectively.

Blood Component Removal↗
PubMed1998

Down-regulation of surface monocyte lipopolysaccharide-receptor CD14 in patients on cardiopulmonary bypass undergoing aorta-coronary bypass operation.

OBJECTIVES: Major operative trauma like aorta-coronary bypass operation may lead to postoperative immunodisturbance, putting the patient at an increased risk for infection and sepsis. The monocyte/macrophage system and the endotoxin receptor CD14 are important in the early recognition and elimination of invading bacteria. The aim of this study was to analyze changes in membrane-associated CD14 and soluble CD14 during and after cardiac involving cardiopulmonary bypass. METHODS: We studied numbers of leukocytes, monocytes, and monocyte subpopulations, expression of monocyte membrane-associated CD14 and plasma levels of soluble CD14 in 10 patients (63 +/- 8 years of age), who underwent elective cardiopulmonary bypass. RESULTS: Cardiopulmonary bypass induced marked postoperative monocytosis, which was maximal 20 hours after the operation (485 +/- 242 cells/microl before, 1080 +/- 264 cells/microl 20 hours after surgery). Expression of membrane-associated CD14 on classical CD14++ monocytes decreased significantly by 40%, reaching a nadir 20 hours after surgery (p < 0.05). At the time of maximal membrane-associated CD14 suppression, the levels of soluble CD14 measured by enzyme-linked immunosorbent assay were clearly increased (3.2 +/- 1.0 microg/ml before versus 5.6 +/- 1.0 microg/ml 20 hours after, p < 0.001). No significant change of the percentage of small (alpha) and large (beta) forms of soluble CD14 was found. CONCLUSIONS: Cardiopulmonary bypass leads to reduced membrane-associated CD14 expression on peripheral blood monocytes and increased levels of soluble CD14 through shedding or secretion of membrane-associated CD14 from the cell surface. These findings indicate that bypass is associated with significant monocyte activation.

Blotting, Western↗
PubMed1998

Asymptomatic right atrial leiomyosarcoma with tricuspid valve obstruction in a young female patient.

Primary cardiac leiomyosarcomas of the heart are rare tumors usually diagnosed post-mortem. Like other sarcomas located in the heart, it causes symptoms by obstruction or occlusion of cardiac cavities, local invasion, embolization or by systemic manifestations. We present an unusual case of a previously healthy young female patient who was accidentally diagnosed with a cardiac tumor of unknown origin during routine physical examination in May 1997. Until a few days prior to elective cardiac surgery for diagnostic purposes in June 1997, no clinical symptoms were present. To our surprise, a primary right atrial leiomyosarcoma was found which almost completely occluded the right atrium and destroyed the tricuspid valve. Despite the combination of surgical removal and adjuvant chemotherapy the patient died 3 weeks after the operation due to progressive tumor disease and development of congestive heart failure and lung embolism.

Adult↗
PubMed1998

Expansion of CD14+CD16+ monocytes in critically ill cardiac surgery patients.

We have asked whether critically ill cardiac valve surgery patients identified by a high APACHE II score exhibit an increase in the number of proinflammatory CD14+CD16+ monocytes. A group of 12 patients was studied over a period of 5 days post cardiac valve surgery for changes in blood monocyte populations. Patients were selected on day 1 post surgery to either be in good clinical condition (APACHE II Score of < or = 14; N = 9) or to be critically ill (APACHE II score of > or = 24; N = 3). The < or = 14 patients had an uneventful course and could leave the ICU after 2-3 days. Among the > or = 24 patients two showed a decrease of the score to < or = 14 within the 5 days of observation and they could leave the ICU thereafter. One > or = 24 patient (patient #2) had a persistently high score and finally died on day 28. Analysis of blood monocytes on day 1 post surgery revealed that the < or = 14 patients had normal values of CD14+CD16+ monocytes (44 +/- 9/microliter). By contrast the > or = 24 patients had increased values of these cells with 243 +/- 106 cells per microliter on day 1. The numbers of CD14+CD16+ monocytes returned to the control range over the 5 days of observation in 2 of the > or = 24 patients concomitant with the improvement of the APACHE II score. CD14+CD16+ monocytes remained, however, at a high level in patient #2, the patient with persistently high APACHE II score.

APACHE↗
PubMed1998

Pentoxifylline decreases the incidence of multiple organ failure in patients after major cardio-thoracic surgery.

We assessed the safety and efficacy of intravenous pentoxifylline [3,7-dimethyl-1-(5-oxohexyl)-xanthine] in patients at risk for developing multiple organ failure after major cardio-thoracic surgery in a single-center, randomized, placebo-controlled study. Of 816 consecutive patients who underwent major cardio-thoracic surgery, 40 who had Acute Physiology and Chronic Health Evaluation II score values > or = 19 at the first postoperative day after the surgery were included. Patients were randomized to receive either placebo (control; n = 25) or intravenous pentoxifylline treatment (pentoxifylline; n = 15) at a dosage of 1.5 mg/kg/h as an adjunct to standard supportive therapy. Main outcome measurements were duration of required ventilator support, intensive care unit stay, and incidence of renal failure. Thirty-seven patients were eligible for evaluation. No significant adverse events related to pentoxifylline treatment were observed. The duration of mechanical ventilation was significantly greater for control patients (8.3 +/- 3.1 days) compared with pentoxifylline-treated patients (3.1 +/- .9 days; p < .05). Patients treated with pentoxifylline experienced fewer days on hemofiltration (1.2 +/- .8 vs. 6.8 +/- 3.3; p < .05) and a shorter intensive care unit stay (5.2 +/- 1.1 vs. 11.4 +/- 3.1 days). There were no intergroup differences in mortality. Mortality was 33% in the pentoxifylline group and 36% among control group patients. In conclusion, supplemental pentoxifylline treatment may decrease the incidence of multiple organ failure in patients at risk of systemic inflammatory response syndrome after cardiac surgery. Additional studies are required to determine the validity of the observed effects.

APACHE↗
PubMed1998

Single-center randomized trial comparing tacrolimus (FK506) and cyclosporine in the prevention of acute myocardial rejection.

BACKGROUND: To compare the efficacy and safety of tacrolimus and cyclosporine in heart transplantation, this single-center, prospective, randomized, open-label clinical trial was undertaken. METHODS: Seventy-three adult patients were randomly assigned at the time of transplantation to receive either tacrolimus (n=43) or cyclosporine (n=30) as the primary immunosuppressant. Ten of the 43 patients in the tacrolimus group received the drug intravenously in the perioperative period; all other patients received only oral tacrolimus. RESULTS: With a mean follow-up of 27 months, patient survival rates (tacrolimus 83%, cyclosporine 81%) were similar. Fewer patients experienced acute rejection in the tacrolimus group (79%) than in the cyclosporine group (100%), but the difference was not statistically significant. The number of infections and dialysis and insulin requirements were similar for the 2 treatment groups, but the proportion of patients requiring multidrug antihypertensive regimens was lower in the tacrolimus group (12.5% vs 50.0% at month 6; p=.025). The interpatient variance in pharmacokinetic parameters in a subset of 10 patients was much higher after the first oral dose of tacrolimus than at steady-state (eg, first-dose time at which maximal concentration is reached (t(max)): 3.5+/-2.5h, steady-state t(max): 2.0+/-0.7h), and patients treated with intravenous tacrolimus (n=13) rather than oral tacrolimus (n=30) reached target concentrations faster and with less interpatient variability (eg, at day 0: 9.72+/-10.9 ng/mL intravenously vs 3.31+/-8.1 orally). CONCLUSIONS: Tacrolimus was associated with similar efficacy and safety profiles compared with cyclosporine. The higher interpatient variance in absorption associated with oral tacrolimus during the first few days after transplantation would suggest that intravenous tacrolimus should be used during the perioperative period.

Administration, Oral↗
PubMed1998

[Control of the patency of coronary artery bypasses with contrast enhanced magnetic resonance angiography].

Contrast-enhanced 3D magnetic resonance angiography (MRA) has the potential for being a reliable method for CABG visualization and CABG patency determination in early postoperative period. 3D reconstruction was helpful in delineating CABG course and in several cases in detecting stenosis of coronary arteries. Compared to coronary angiography MRA is a non-invasive examination technique without iodine contrast medium and X-ray and is practicable in 30 min with minimal risk and low costs.

Aged↗
PubMed1997

Aggressive lowering of fibrinogen and cholesterol in the prevention of graft vessel disease after heart transplantation.

BACKGROUND: A combined treatment of statins and extracorporeal H.E.L.P.-apheresis (Heparin-mediated Extracorporeal LDL/fibrinogen Precipitation) has already been shown to be beneficial for coronary artery disease (CAD). Presumably high levels of LDL cholesterol, Lp(a), and fibrinogen also increase the risk for graft vessel disease (GVD). Therefore, we studied whether this concept can be applied in GVD, based on the hypothesis that GVD is an accelerated form of CAD. METHODS AND RESULTS: For comparison of statin treatment alone with the combined treatment, two matched groups of 10 cardiac transplant recipients were studied during a mean period of 3.6+/-1.0 years. Both groups were comparable in clinical characteristics, immunosuppressive medication, baseline plasma Lp(a), and high fibrinogen levels. Group I had normal LDL-C levels (3.36+/-0.60 mmol/L). Simvastatin alone was administered in this group to counteract the LDL-increasing effect of the immunosuppressive medication. Group II had marked hypercholesterolemia (LDL-C, 6.07+/-1.89 mmol/L), which was treated, in addition to simvastatin, with H.E.L.P.-apheresis weekly. GVD was assessed by coronary angiography. Simvastatin alone kept LDL-C levels within baseline limits but could not prevent GVD in 7 of 10 patients. In contrast, the combined treatment prevented GVD in 9 of 10 patients (P=.006) by simultaneous and drastic reduction of 48% LDL-C (P=.006), 35% fibrinogen (P=.002), and 47% Lp(a) (P=.006) below baseline. Both treatments were well tolerated and did not affect prevention of graft rejection and infections. CONCLUSIONS: A strategy of early, drastic lowering of fibrinogen, LDL-C, and Lp(a) helps to prevent GVD.

Adult↗
PubMed1997

Long-term results of total repair of tetralogy of Fallot in adulthood: 35 years follow-up in 104 patients corrected at the age of 18 or older.

Long-term survival after surgical repair of tetralogy of Fallot (TOF) is reported to be excellent if the patients are corrected in childhood. However, age at operation has been demonstrated as an important risk-factor. The aim of our study was to investigate whether adult patients also benefit from surgery. From December 1958 to May 1977, 739 patients underwent a correction of their TOF with pulmonary stenosis at our institution. Foreigners (n = 52) and those who moved to a foreign country (n = 13) were excluded from further analysis. Sixteen patients were lost during follow-up (98% complete). Of the remaining patient population (n = 658; mean age: 12.2 +/- 8.6 years; range 2-67 years), 104 patients were 18 years or older at the time of correction. Operative (n = 25) and one-year (n = 8) deaths were excluded for long-term calculations, resulting in a study group of 71 patients. Actuarial 10, 20, 30, and 35-year survival rates were 94%, 93%, 83%, and 72% respectively, and not different from normal life expectancy. The most common cause of death was congestive heart failure (n = 3), followed by myocardial infarction (n = 2) and sudden death (n = 2). Parameters influencing longterm survival could not be detected. At follow-up (mean 27.7 years), more than 80% (n = 48) of the 58 survivors reported themselves to be in NYHA functional class I or II and 95% (n = 55) were in a better condition than before the operation. Repair of tetralogy of Fallot in adulthood shows excellent results with normal life expectancy for the patients.

Adult↗
PubMed1997

Comparison of early IgM-enriched immunoglobulin vs polyvalent IgG administration in score-identified postcardiac surgical patients at high risk for sepsis.

STUDY OBJECTIVE: To address the relevance of the IgM component in polyvalent immunoglobulins in sepsis treatment by comparison of the clinical course under polyvalent IgG vs IgGMA therapy in postcardiac surgical patients at high risk for sepsis and to reassess the prognostic validity of sequential changes in acute physiology and chronic health evaluation (APACHE II) scores during treatment. DESIGN: Prospective, randomized clinical trial. SETTING: Cardiac surgical ICU in a university hospital. PATIENTS: Among 870 consecutive patients after elective open-heart surgery, 29 (3.3%) met the previously validated high-risk criterion (APACHE II score > or = 24 on the first postoperative day) with a mean APACHE II score-predicted mortality risk of 63%. INTERVENTIONS: In addition to standard therapy, 27 of these patients were randomized to receive commercially available IV IgG (Polyglobin N, n = 14, total dosage: 18 mL/kg) or IgGMA (Pentaglobin, n = 13, total dosage: 15 mL/kg). MEASUREMENTS AND RESULTS: The two groups were comparable in baseline disease severity and concurrent therapy. The extent of score-quantified improvement in disease severity during treatment was similar in both groups (mean fall in APACHE II scores within 4 days; IgG, -6.9; IgGMA, -5.2), as were score-defined improvement rates (rate of patients with score decrease > or = 7 within 4 days: IgG, 57%; IgGMA, 54%) and in-hospital mortality (IgG, 29%; IgGMA, 31%) (all p = NS). There was a strong association between the decrease over time in APACHE II scores during therapy and prognosis (mortality rates in patients with vs without score-assessed improvement: 0% vs 67%, p = 0.0002). CONCLUSIONS: IgG and IgGMA were associated with a comparable improvement in disease severity in score-identified postcardiac surgical patients at high risk for sepsis. Given the design as an efficacy rather than an equivalence study, this hypothesis derived from our results needs independent validation in larger trials. Sequential APACHE II score changes were reconfirmed as a prognostically valid quantitative measure of disease progress during sepsis therapy.

APACHE↗
PubMed1997

Surgical therapy for coronary artery disease in patients with a left ventricular ejection fraction of 25% or less.

BACKGROUND: In patients with advanced coronary artery disease (CAD) and markedly decreased left ventricular ejection fraction (EF) symptoms of myocardial ischemia and insufficiency may be complicated by ventricular arrhythmias. Appropriate surgical therapy must be tailored to the individual symptoms. The aim of this study was to compare the different current methods. METHODS: From 9/1990 to 9/1994 138 patients with coronary artery disease and a left ventricular EF of < or = 25% were operated. Patients with dominating Angina pectoris and vital myocardium were revascularized (ACB; n = 17); two of these patients were 12 and 37 months p.o. transplanted. Because of dominating dyspnea, diffuse CAD and missing AP heart transplantation seemed indicated (HTX; n = 102). In two of these patients ventricular assist devices were implanted as a bridge to transplantation; both patients survived. Patients with malign tachycardias received either an implantable cardio-defibrillator (ICD; n = 16) or had arrhythmia surgery (ARS; n = 3). Patients of the HTX-Group were younger (54 vs 60 years; p < 0.05), had more often previous surgery (28% vs 20%) and were in worse conditions (NYHA 3.5 vs 3.0; p < 0.05). RESULTS: The main cause of death after transplantation was multi-organ failure (MOF; 14/102; 13.8%). The best long-term survival (87% after 3.2 years, p < 0.01 vs HTX)-with low average functional classes (NYHA 2.9)-had the patients after ICD implantation. The best quality of live (NYHA 1.1; p < 0.01 vs ICD)-associated with a high mortality due to preoperatively impaired organ-systems (62% operative survival, 57% 4-years survival)-was achieved by transplantation. In patients with a history of ventricular arrhythmias, who are waiting for a transplantation, the implantation of an ICD should be considered. Bypass surgery as well as arrhythmia surgery showed good survival (1-year survival 82% and 66% respectively) and functional results (NYHA 1.7 and 1.5 respectively).

Arrhythmias, Cardiac↗
PubMed1997

Tacrolimus: a superior agent to OKT3 for treating cases of persistent rejection after intrathoracic transplantation.

Acute myocardial rejection refractory to treatment still contributes significantly to patient death after intrathoracic transplantation. A historical series of 25 patients who received OKT3 (5 mg/day for 10 days) was compared with our current experience with 14 patients treated with tacrolimus (0.1 mg/kg/day targeting whole blood concentrations of 13 to 18 ng/ml): all 39 patients having persistent rejection unresponsive to treatment at the time of conversion. Mean periods of follow-up were 842.9 days and 342.6 days, respectively. Actuarial 1-year patient survival rates were 64.0% and 76.2% for the OKT3 and tacrolimus treatment groups, with most of the deaths in the OKT3 group occurring early (p = 0.064). Causes of death for patients receiving OKT3 included acute rejection (n = 5), infection (n = 3), carcinoma (n = 2), multiorgan failure (n = 1) and graft vessel disease (n = 1). The two deaths in the tacrolimus treatment group were the result of infections. Eighty percent of patients treated with OKT3 subsequently experienced further rejection episodes, in many cases necessitating methotrexate therapy. In contrast, only one patient (7.1%) from the tacrolimus group was diagnosed with rejection after conversion (p < 0.001). In conclusion, when compared with OKT3 therapy, a switch in baseline immunosuppression from cyclosporine to tacrolimus seems to be markedly more effective, as well as being safe for the treatment of persistent acute rejection.

Actuarial Analysis↗
PubMed1996

Early prediction of outcome in score-identified, postcardiac surgical patients at high risk for sepsis, using soluble tumor necrosis factor receptor-p55 concentrations.

OBJECTIVE: To investigate the prognostic value of increased serum concentrations of soluble tumor necrosis factor (TNF) receptors in patients at high risk for sepsis. DESIGN: Prospective study. SETTING: Cardiac surgical intensive care unit in a University Hospital. PATIENTS: Those 27 of 870 consecutive postcardiac surgical patients who met a previously validated high-risk criterion for imminent sepsis (Acute Physiology and Chronic Health Evaluation II [APACHE II] score of > or = 24 on the first postoperative day [day 1]). In this population, systemic inflammatory response syndrome was present in 96% of the patients and the in-hospital mortality rate was 30%. In addition, ten postcardiac surgical patients with an uncomplicated course (mortality rate 0%) were studied for comparison. INTERVENTIONS: Blood sampling for measurements of serum concentrations of TNF and soluble TNF receptors 55 kilodalton (TNF receptor-p55) and 75 kilodalton (TNF receptor-p75) on days 1, 2, 3, and 5. MEASUREMENTS AND MAIN RESULTS: Compared with the ten patients with an uncomplicated course (group A), the high-risk patients had significantly higher baseline (day 1) serum concentrations of soluble TNF receptor-p55 (9.2 vs. 4.2 ng/mL) and soluble TNF receptor-p75 (9.2 vs. 5.5 ng/mL). These high-risk patients could be further differentiated into two subgroups: one (B) with a prompt decrease in APACHE II score and a good prognosis (mortality rate 0%) and another (C) with a persisting high risk of sepsis and mortality rate (40%, p < .05). Although baseline APACHE II score was similar in both high-risk subgroups, soluble TNF receptor-p55 concentrations were significantly higher in subgroup C compared with subgroup B already at baseline (10.7 vs. 4.7 ng/mL). The receiver operating characteristic curve for subgroup classification by soluble TNF receptor-p55 was in a discriminating position with an area (0.773 +/- 0.096), confirming soluble TNF receptor-p55 as a predictor of mortality. TNF and soluble TNF receptor-p75 concentrations were less predictive at baseline. CONCLUSIONS: This study suggest that increased soluble TNF receptor-p55 concentrations in the serum of postcardiac surgical patients allow earlier prognostication of subsequent hospital course than APACHE II scores alone. This study further suggests that the combination of physiologic scores and cytokine receptor measurements could improve the predictive power of early postoperative risk stratification.

APACHE↗
PubMed1995

Significance of prophylactic urodilatin (INN: ularitide) infusion for the prevention of acute renal failure in patients after heart transplantation.

Acute renal failure is a serious problem following heart transplantation. In first uncontrolled clinical trials, Urodilatin revealed beneficial effects in the prophylaxis and therapy of acute renal failure following heart and liver transplantation. Here, we present the first randomized, placebo-controlled, double-blind study on 24 patients following heart transplantation to investigate whether prophylactic i.v. Urodilatin infusion can prevent acute renal failure requiring renal replacement therapy. Postoperative drug management was characterized by intravenous application of high furosemide, cyclosporine, and vancomycin doses. Urodilatin infusion was started postoperatively with a dose of 40 ng / kg bw / min for 6 days. 6 of the 12 patients in the Urodilatin group and 6 of the 12 patients in the placebo group had a stable diuresis (3 - 4 l / day) during the study period of 6 days. In contrast, the remaining 6 patients of each group developed oliguria / anuria and required subsequent hemofiltration / hemodialysis. Cumulative duration of hemofiltration (88 +/- 7.39 hours in the placebo treated patients versus 44 +/- 5.35 hours in the Urodilatin treated patients, p < 0. 05) as well as frequency of hemodialysis (3.0 +/- 0.49 times in the placebo group vs 1.2 +/- 0.29 times in the Urodilatin group, p < 0. 05) were significantly reduced using Urodilatin. Mean arterial blood pressure was stable during the Urodilatin infusion period and was not different to that observed in placebo patients. We conclude that Urodilatin does not reduce the incidence of acute renal failure and the subsequent requirement for hemofiltration / hemodialysis in our patient population, but seems to reduce the duration of hemofiltration and frequency of hemodialysis compared to the placebo group.

Acute Kidney Injury↗
PubMed1995

[Intra-aortic balloon counterpulsation as percutaneous therapy option in cardiogenic shock].

Six months after sustaining a posterior wall myocardial infarction a 40-year-old man had a further infarction in the anterior wall region. After thrombolysis treatment with recombinant tissue plasminogen activator the patient was at first symptom-free and haemodynamically stable, but 48 hours later another anterior wall re-infarction occurred with cardiogenic shock. Despite infusions of catecholamines at highest dosage and successful coronary angioplasty the circulation became critically unstable and percutaneously introduced intraaortic balloon counterpulsation (IABCP) was commenced. As the haemodynamics improved catecholamine dosage was markedly reduced and then discontinued over the subsequent 24-48 hours and inspiratory oxygen concentration of the ventilated patient was decreased from 100% to 40%. After a total of 5 days the IABCP catheter was removed without complication. The cardiac pump action showed further improvement in the following days. 6 months later the patient's condition was stable in grade II-III (New York Heart Association classification) heart failure. This case illustrates the place of IABPC as a highly effective treatment option in myocardial infarction with cardiogenic shock, especially when combined with interventional revascularisation procedures.

Adult↗
PubMed1995

Experience with the Novacor left ventricular assist system as a bridge to cardiac transplantation, including the new wearable system.

The three components of the Novacor left ventricular assist system, compact controller, battery, and back-up battery, have been miniaturized in the development of the wearable system. Therefore patients can be fully mobilized receiving mechanical circulatory support while awaiting heart transplantation. Between February 1992 and April 1994 a total of eight patients with decompensated heart failure (6 dilated cardiomyopathy, 1 acute myocarditis, 1 ischemic cardiomyopathy) were treated with the Novacor left ventricular assist systems. In the most recent four cases the wearable system (N100P) was used. Patients' ages ranged from 17 to 49 years. In five patients severe failure of the right side of the heart was present at the time of implantation. Hemodynamic stabilization was achieved in all patients during the 2 to 122 days (mean 30.8 +/- 42.5 days) of support. The following parameters were measured on average before and 24 hours after implantation of the left ventricular assist system: mean arterial pressure 70 +/- 11 versus 87 +/- 13 mm Hg (p < 0.05), cardiac index 1.71 +/- 0.42 versus 3.23 +/- 0.74 L/min/m2 (p < 0.05), pulmonary capillary wedge pressure 27.1 +/- 4.4 versus 9.9 +/- 5.2 mm Hg (p < 0.01), mean pulmonary pressure 41 +/- 9 versus 27 +/- 6 mm Hg (p < 0.05), and right ventricular ejection fraction 16.7% +/- 10.3% versus 22.0% +/- 11.6% (not significant). Patients who received the wearable system were capable of managing their own power supply during the bridging period and were able to walk to the hospital park and shopping area. One patient had a serious pulmonary infection, which was treated successfully, and two patients had a cerebrovascular accident, which resolved in one and resulted in a minor residual deficit in the other. All eight patients received a heart transplant. One patient died early after transplantation and seven patients are alive and well. In summary, the wearable Novacor left ventricular assist system provides major advantages regarding quality of life of patients during mechanical circulatory support. However, there is a remaining risk of thromboembolism despite anticoagulation therapy.

Adolescent↗
PubMed1994

Chimeric monoclonal CD4 antibody--a novel immunosuppressant for clinical heart transplantation.

The murine CD4 monoclonal antibody (mAb) M-T412 effectively downregulates T-helper-inducer function, while exhibiting high affinity and specificity for an epitope formed by the V1 and V2 domain of CD4. The antibody was chimerized by combining the murine VH and VL parts to the constant region of a human IgG1 kappa immunoglobulin. This chimeric CD4 monoclonal antibody (chim CD4 mAb) cM-T412 was used for adjunct immunosuppression in addition to standard triple-drug therapy for patients after orthotopic (n = 10) and heterotopic (n = 1) heart transplantation (HTx). cM-T412 was administered intraoperatively and postoperatively on days 1-7, 9, 11, 13, 17, and 21. A control group of similar composition (10 orthotopic, 1 heterotopic HTx) was conventionally treated in an adjunct fashion with antithymocyte globulin (ATG) until cyclosporine (CsA) in serum had reached therapeutic levels. Over the total observation time (mean: 600 days), the number of acute rejection episodes per 100 patient days was 0.26 in the cM-T412 group versus 0.41 in the control group, indicating a reduction of nearly 40%. Four of the 11 patients in the CD4 group have thus far not experienced any rejection crisis compared with two out of 11 in the control group. The mean time to the first rejection episode was 43.7 days in the CD4-treated patients versus 25.3 days in the control group. In addition the interval to the second rejection episode was longer in CD4 patients than in controls. Furthermore, patients treated with chim CD4 mAb had fewer episodes of infection during the first year after HTx (0.49 vs. 0.91 per 100 pt. days) and had a better overall survival rate (91% vs. 73%) than control group pts. No anaphylactic reaction was observed. The only adverse event probably related to cM-T412 infusion was a transient decrease of blood pressure in one patient. Although this study has only a limited number of patients, addition of cM-T412 to standard triple drug therapy appears to be an effective, specific, and well tolerated adjunct to current immunosuppression that offers a new approach for an improved immunomodulatory regimen after heart transplantation.

Adult↗