Enoximone therapy as pharmacological bridging to cardiac transplantation.

Keeping pre-transplant patients alive while waiting for a suitable donor is still a major challenge. New pharmacological agents which can provide improved hemodynamics are urgently needed in patients with severe heart failure who are on the waiting list for cardiac transplantation. Intravenous enoximone therapy (an initial 0.5 mg/kg bolus, then 1.25-5.0 mcg/kg/min infusion) was administered to 35 transplant candidates with progressive heart failure despite optimal drug regimen including digoxin, diuretics, and ACE-inhibitors. In 18 out of 35 patients complete hemodynamic, echocardiographic, neurohumoral, and Holter-ECG studies were performed before and 24 hours after intravenous enoximone infusion. Patients were then continued on chronic oral therapy of 100 mg twice a day. Enoximone infusion increased the cardiac index (CI) (1.78 +/- 0.45 l/min/m2 vs 3.04 +/- 0.83 l/min/m2; p < 0.001) and stroke volume index (SVI)(22.33 +/- 9.45 ml/m2 vs 32.28 +/- 7.29 ml/m2; p < 0.05) and decreased wedge pressure (PCP)(24.1 +/- 11.98 mmHg vs 17.78 +/- 8.76 mmHg; p < 0.05) while mean arterial pressure (MAP) was unchanged. Left ventricular ejection time (LVET)(225.1 +/- 26.9 ms vs 242.2 +/- 25.8 ms; p < 0.05) was increased whereas other echocardiographic parameters were unchanged (Left ventricular end-diastolic dimension LVEDD, left ventricular end-systolic dimension LVESD, fractional shortening FS, early diastolic relaxation parameter Te). Plasma neurohumoral parameters did not change (Aldosterone, epinephrine, renin, atrial natriuretic factor) except for a significant drop in norepinephrine (936.7 +/- 443.2 pg/ml vs 522.4 +/- 287.6 pg/ml; p < 0.05). Holter-ECG parameters (ventricular premature beats VPB, couplets, ventricular tachycardia VT) were not influenced by enoximone infusion.(ABSTRACT TRUNCATED AT 250 WORDS)

[Primary results and long-term outcome of an ambulatory, cardiac rehabilitation model (phase II) after myocardial infarct, dilatation treatment and heart operation]. / Primärergebnisse und Langzeiteffekt eines ambulanten, kardialen Rehabilitationsmodells (Phase II) nach Myokardinfarkt, Dilatationsbehandlung und Herzoperation.

From October 1994 to July 1996, 128 patients (30 women, 98 men) participated in an outpatient cardiac rehabilitation program (phase II). Our objectives were to demonstrate risk-factor modification and increased work-load capacity resulting directly from the rehabilitation in terms of primary results and long-term effects, 6 months (n = 59) and 12 months (n = 30) after termination of the program. We observed how many of the patients were able to be occupationally re-integrated after completion of phase II rehabilitation. During the 4-week program, the work-load capacity increased significantly from 1.2 W/kg to 1.5 W/kg (p < or = 0.05). After 6 months (1.4 W/kg) and 1 year (1.5 W/kg), consistently high workload capacities were noted. Total cholesterol decreased significantly from 247 mg/dl to 201 mg/dl (p < or = 0.05) during the 4-week program. After 6 months (219 mg/dl) and 1 year (210 mg/dl) significant reductions persisted (p < or = 0.05). Similar results with LDL-cholesterol were seen: 185 mg/dl before entering the program, 146 mg/dl after 4 weeks, 158 mg/dl after 6 months and 151 mg/dl after 1 year. Triglyceride levels showed a significant reduction (p < or = 0.05), 189 mg/dl before entering in the program, 148 mg/dl after 4 weeks, 143 mg/dl after 6 months, and 135 mg/dl after 1 year. The HDL-levels increased slightly as a long-term effect, i.e., from 51 mg/dl to 49 mg/dl during the 4 week program, and 57 mg/dl after 6 and 12 months. Of the patients questioned (n = 73), 73% found the program very good, 27% said it was good, and no patient was dissatisfied. Of the 63 patients who were actively employed before becoming ill and later entered our program, 51 (81%) were able to be immediately re-integrated into their previous occupation. In several cases this re-integration took 7 weeks. Seven (11%) patients applied for pension, and 5 (8%) patients remained unemployed on sick-leave.

[Outcome of a four-week ambulatory cardiac rehabilitation (phase II) on cardiovascular risk factors, physical fitness and occupational reintegration in patients after myocardial infarct, dilatation treatment and heart operation]. / Auswirkungen einer vierwöchigen ambulanten kardialen Rehabilitationsmassnahme (Phase II) auf kardiovaskuläre Risikofaktoren, körperliche Belastbarkeit und berufliche Reintegration bei Patienten nach Myokardinfarkt, Dilatationsbehandlung und Herzoperation.

From October 1994 to July 1996, 128 patients (30 women, 98 men) participated in an outpatient cardiac rehabilitation program (phase II). Our objectives were to demonstrate risk-factor modification and increased workload capacity resulting directly from the rehabilitation in terms of primary results and long-term effects 6 and 12 months (n = 118, Figure 1) respectively 1.5 and 2 years (n = 87) after termination of the program (Tables 9 to 12). We observed how many of the patients were able to be occupationally reintegrated after completion of phase-II rehabilitation. Workload capacity significantly increased from 1.2 W/kg upon entry to 1.5 W/kg (p < or = 0.05) upon completion of 4 weeks cardiac rehabilitation. Workload capacity remained consistently high at 6 months and 1 year (1.5 W/kg) and at 1.5 and 2 years (1.7 W/kg). Total cholesterol decreased significantly from 247 to 201 mg/dl (p < or = 0.05) during the 4-week program. Significant cholesterol (p < or = 0.01) reductions persisted at 6 months (216 mg/dl) and 1 year (215 mg/dl). After 1.5 and 2 years, the total cholesterol was less than 14% and 17% below the mean of cholesterol at the beginning of the program. Similarly, LDL cholesterol was 185 mg/dl before entering the program, 146 mg/dl after 4 weeks, 151 mg/dl after 6 months and 149 mg/dl after 1 year. Triglyceride levels showed a significant reduction (p < or = 0.01) with levels 189 mg/dl before entering the program, 148 mg/dl after 4 weeks, 151 mg/dl after 6 months and 154 mg/dl after 1 year. LDL cholesterol and triglyceride levels did not significantly increase after 1.5 and 2 years. The HDL cholesterol increased slightly as a long-term effect (from 51 mg/dl before entering the program to 55, 56 and 54 mg/dl after 1, 1.5 and 2 years, respectively). Seventy-three percent of the patients questioned (n = 73) found the program very good, 27% said it was good and no patient was dissatisfied. Fifty-one (81%) of the 63 patients who were actively employed before becoming ill and later entering our program were immediately able to be reintegrated into their previous occupation. In several cases reintegration took 7 weeks. Seven (11%) patients applied for pension, 5 (8%) patients remained unemployed on sick-leave.

[Planimetric quantification of aortic valve stenoses using multiplanar transesophageal echocardiography]. / Planimetrische Quantifizierung von Aortenklappenstenosen mittels multiplaner transösophagealer Echokardiographie.

Standard techniques used in order to quantify the severity of aortic valve stenoses in clinical practice comprise: transthoracic echocardiography, namely, by determining maximum and mean transvalvular gradients and evaluating aortic valve areas, as well as invasive techniques which quantify aortic valve areas through hemodynamic pressure measurements and application of the Gorlin formula. Since the introduction of the multiplane TEE technique, it has become feasible to scan the aortic valve in a strictly horizontal plane and quantify the aortic valve orifice by planimetry. In this study, we investigated 23 patients with various degrees of aortic valve stenoses. We compared aortic valve areas, which had been planimetrically determined by multiplane TEE scans, and mean aortic valve gradients (standard TEE technique) with pressure gradients and valve areas derived from hemodynamic measurements obtained during cardiac catheterization, and have found that the valve areas as well as the mean pressure gradients correlate well.

Low-dose enoximone therapy in pre-transplant patients: hemodynamic, echocardiographic, and neurohumoral findings.

Keeping pre-transplant patients alive while waiting for a suitable donor to be found is still a major challenge. New pharmacological agents which can provide improved hemodynamics are urgently needed in patients with severe heart failure who are on the waiting list for cardiac transplantation. Intravenous enoximone therapy (an initial 0.5 mg/kg bolus, then 1.25-5.0 mcg/kg/min infusion) was administered to 18 transplant candidates with heart failure progression despite optimal drug regimen including digoxin, diuretics, and ACE-inhibitors. Complete hemodynamic, echocardiographic, and neurohumoral studies were performed before and 24 h after intravenous enoximone infusion. Enoximone infusion increased cardiac index (1.78 +/- 0.45 l/min/qm vs. 3.04 +/- 0.83 l/min/qm; p < 0.001) and stroke volume index (22.33 +/- 9.45 ml/qm vs. 32.28 +/- 7.29 ml/qm; p < 0.05) and decreased wedge pressure (24.1 +/- 11.98 mmHg vs. 17.78 +/- 8.76 mmHg; p < 0.05) and systemic vascular resistance (1700.8 +/- 555.8 dyn x s x cm-5 vs. 952.8 +/- 384.0 dyn x s x cm-5; p < 0.001). Heart rate and mean arterial pressure were unchanged. Left ventricular ejection time (225.1 +/- 26.9 ms vs. 242.2 +/- 25.8 ms; p < 0.05) was increased, whereas other echocardiographic parameters were unchanged (left ventricular end-diastolic dimension, left ventricular end-systolic dimension, fractional shortening, early diastolic relaxation parameter Te). Plasma neurohumoral parameters did not change (aldosterone, epinephrine, renin, atrial natriuretic factor) except for a significant drop of norepinephrine (936.7 +/- 443.2 pg/ml vs. 522.4 +/- 287.6 pg/ml; p < 0.05).(ABSTRACT TRUNCATED AT 250 WORDS)

[The PreFord Study. A prospective cohort study to evaluate the risk of a cardiovascular event (overall-collective) as well as a prospective, randomized, controlled, multicentre clinical intervention study (high-risk-collective) on primary prevention of cardiovascular diseases in the Ford Motor Company employees in Germany]. / Die PräFord-Studie. Prospektive Kohortenstudie zur Bewertung des Risikos für ein kardiovaskuläres Akutereignis (Gesamtkollektiv) sowie eine prospektive, randomisierte, kontrollierte, multizentrische klinische Interventionsstudie (Hochrisikoteilkollektiv) in der Primärprävention von Herz-Kreislauferkrankungen bei Mitarbeitern der Firma Ford in Deutschland.

The PreFord Study is a multicenter prospective cohort study to evaluate guideline based risk management on primary prevention of cardiovascular diseases. Furthermore a randomised controlled trial (RCT) will be designed to analyse the effect of a special intervention program. 40,000 employees of the Ford Motor Company, Visteon Company and Deutz Company in Germany will be included, monitored for ten years and the following primary endpoints will be investigated: 1. evaluation and comparison of established and newly developed risk-scores, 2. the relative impact of single and combined cardiovascular risk factors on cardiovascular diseases, 3. the influence of a novel occupationally integrated ambulant rehabilitation program in combination with a guideline oriented optimal drug therapy within a high risk group on the primary endpoint: risk reduction by, 4. the influence of this intervention on secondary endpoints: death, myocardial infarction and stroke, combined appearance of angina pectoris and hospitalisation, occurrence of cerebral circulatory disorder and hospitalisation, occurrence of peripheral occlusive arterial disease and hospitalisation and single cardiovascular risk factors and cost-benefit-analysis. Beginning with an cross sectional study there will be a systemic screening of cardiovascular risk profiles, of anthropometric data and different lifestyle-factors. Based on these data participants will be differentiated into three risk-groups according to the risk score of the European Society of Cardiology (risk of a lethal primary acute cardiovascular event: I < or = 1%; II > 1-< 5% and III > or = 5%). In the following longitudinal study different strategies will be applied: Group I: low risk (< 0.5% per year): repetition of the investigation after five and ten years. Group II: middle risk, (0.6% to 1.4% per year), repetition of the investigation every two years, instruction of the patients general practitioner (GP) with respect to a risk factor oriented and evidence based treatment. Group III: high risk, (> 1.5% per year or >15% within the next 10 years) will be randomised into two interventional groups. The first one, the intervention-group "PreFord" will perform an occupational integrated rehabilitation program (2,5-3 hours twice a week, for 15 weeks according to the BAR guidelines) with a following engagement in heart-groups and an annual repetition of the check-ups. The second group, the "classic" intervention-group will be treated evidence based in cooperation with their GP. As a result of this long term interventional study efficient, area wide implementable and economically feasible prevention concepts with special regards to operational healthcare will be developed and evaluated. Core elements will be exercise- and lifestyle-oriented concepts as well as guideline-based pharmacotherapy.