Implementation of evidence-based therapy in patients with systolic heart failure from 1998-2000.

BACKGROUND: In recent years, the incidence of systolic heart failure has increased. Besides a complete revascularization, guideline-based medication represents the most effective therapeutic approach. AIM: Analysis of adherence of guideline-recommended and actual medication during inpatient cardiac rehabilitation as well as under subsequent outpatient conditions. METHODS: From 01/1998 to 12/ 2000, 1346 consecutive patients (64 +/- 10 years, 73% male, LVEF 36.3 +/- 8%, 88% ischemic, 6.7% valvular cardiomyopathy, 5.3% other causes, 11.8% atrial fibrillation) were included in a singlecenter prospective register. Medication was recorded at discharge and after the follow-up period of 731 +/- 215 days. Trends in prescription rates were analyzed based on nonparametric correlations (Spearman's-Rho). Changes in medication from in- to outpatient settings were analyzed using exact McNemar test. RESULTS: At discharge 75.3% (67.9%/68.9%/ 86.6% in 1998/1999/2000, p <0.001) of the patients were treated as recommended. This rate dropped to 68.3% at followup (p <0.0001). Mortality within the follow-up period was low (12.6%). CONCLUSION: It could be shown that from 1998 to 2000 inpatient guideline conformity was implementable adequately. Outpatient conformity was significantly lower. Although a high proportion of correctly prescribed CHF medication could be demonstrated, a further effort to improve guideline adherence in the management of heart failure patients is desirable.

Experience with INR self-management: patient selection and complication rates.

BACKGROUND: INR self-management can reduce the risk of complications for patients with indication of long-term oral anticoagulation therapy. However, little is known about early indicators of complication risk. METHODS: In a prospective study on 330 consecutive patients all participants were informed about oral anticoagulation by a structured teaching program. The two groups were divided as to whether they received usual medical care provided by a family physician (n=220) or self-management (n=110) on a portable coagulation monitor (CoaguChek System). After a mean follow up of 13.3+/-4.4 months, the participants of the study were interviewed by a structured questionnaire to obtain information about hemorrhagic and thromboembolic complications as well as survival. RESULTS: In comparison to patients under usual care, patients with INR selfmanagement were significantly younger (58 vs 64 years) and had fewer comorbidities (diabetes and hypertension) as well as a higher ejection fraction (53.6 vs 51.1%). Indication for anticoagulation, age and heart rhythm explained 58% of the differences between the management groups. There was no significant difference in the overall complication rates between the two groups (usual care vs selfmanagement): major bleeding 0.5 vs 0.9%, cerebral embolism (TIA or stroke) 1.9 vs 0.9%, hospital admission 2.3 vs 1.8%. A high BMI (OR=1.5; 95% CI 1.06-1.25; p=0.001) or a high therapeutic INR range (OR=2.42; 95% CI 1.16-5.1; p=0.019) is associated with a higher complication rate. CONCLUSIONS: Complication rates for patients with long-term oral anticoagulant therapy did not differ significantly between usual care and self-management. Rather, the patient's body weight and the requirement of high anticoagulation intensity drive the complication risk under both management systems.

Self-management of oral anticoagulation in nonvalvular atrial fibrillation (SMAAF study).

UNLABELLED: Most patients with atrial fibrillation are at risk of suffering thromboembolic events. This risk can be reduced by twothirds by efficient anticoagulation. This prospective multi-center trial investigated whether the quality of treatment can be improved by self-management in patients with atrial fibrillations (SMAAF Study) compared to conventional patient management by the family doctor. METHODS: Two thousand patients suitable for self-management were to be randomized into the two arms of the study. In the period of investigation from December 1999 to July 2001, only 202 patients (64.3+/-9.2 years, 69.3% men) consented to participate. The study was discontinued prematurely since the number of patients was too low. As a consequence, the group comparison is confined to the evaluation of the INR values measured using the two-tailed t test. RESULTS: Of the 202 patients included, 101 were assigned to the self-management group (64.6+/-9.6 years, 71.4% men) and 101 (64.1+/-8.9 years, 61.4% men, n.s.) were assigned to the group managed by the family doctor. The total number of INR measurements was 2 865. This comprised 2 072 measurements in patients under self-management and 793 in the family doctor group. The values were within the target range significantly more frequently (p=0.0061) in patients under self-management (67.8%) as compared to the family doctor group (58.5%). There was a trend with regard to the time within target range, but the difference was not significant (178.8+/-126 days as compared to 155.9+/-118.4 days). In the self-management group, there were two severe hemorrhages, and there was one thromboembolic event in the family doctor group. CONCLUSION: Management of oral anticoagulation by INR self-management in patients with atrial fibrillation is not inferior to conventional care.

[Acceptance of a patient passport in secondary prevention of coronary heart disease]. / Akzeptanz eines Patientenpasses in der Sekundärprävention der koronaren Herzkrankheit.

BACKGROUND AND OBJECTIVE: Over the long term a large percentage of patients exhibit inadequately managed cardiovascular risk factors following an acute cardiac event. It remains unclear whether the patients would accept a health pass and which sociodemographic variables have an effect on the number of its users. PATIENTS AND METHODS: 437 patients (25% women, 69 +/- 10 years; 75% men 63 +/- 10 years) with diagnosed coronary heart disease were issued a health pass before being discharged from in-patient rehabilitation care. Besides their medical history, the passes contained the patients' latest values for hypertension, glucose, lipids, body mass index (kg/m(2)), and smoking. How many patients actually use the health pass was checked by the patients' physicians after 3, 6, and 12 months. In addition, cardioprotective drugs and cardiac events were logged. RESULTS: 185 (44%) of the patients used the pass continually over the course of one year. These patients tended to be older (> or = 60 years vs. < 60 years, p = 0.023), to be white-collar workers (white-collar vs. blue-collar, p = 0.043), and to have a higher level of education (> 10th class vs. < or = 10th class, p = 0.039) compared to "non-users". CONCLUSION: The acceptance of a passport is low, because fewer than half the patients used it in connection with the secondary prevention of coronary heart disease. Therefore the health pass in its present form did not show up as a useful device in patient care, particularly in single persons and those of a low sociodemographic status.

Cardiac rehabilitation in patients with implantable defibrillators. Feasibility and complications.

OBJECTIVE: We examined patients with implantable cardioverter defibrillators (ICD) in order to demonstrate their safe participation in a standard rehabilitation program. DESIGN: Prospective cohort study of a consecutive series of patients after ICD implantation. Setting Inpatient rehabilitation center. PATIENTS AND METHODS: A total of 118 patients (73.7% male, mean age 60+/-11 years) took part for 23 +/- 4 days in a standard inpatient rehabilitation program including physical activity, psychological care, heart function seminars, and resuscitation exercises with family members. The following noninvasive tests were performed: symptomlimited exercise testing, two-dimensional echocardiography, Holter monitoring, telemetric ICD interrogation, optional fluoroscopy or X-ray examination of the thorax, and (in some patients) defibrillation threshold testing. RESULTS: Out of 118 patients 101 patients (85.6%) participated in regular ergometer training during which the initial workload of 23 +/- 11 Watts could be increased to 45 +/- 18 Watts. An individual conditioning program was assigned to 15% (n = 17) patients, thereby enabling the inclusion of all patients in the rehabilitation process. Under these conditions 12 patients (10%) experienced ICD malfunctions requiring therapy. As a consequence of all cardiac function tests, ICD reprogramming was necessary in 26 patients (22.1%). CONCLUSION: Following ICD implantation, patients may participate in a standard rehabilitation program without serious complications and with a significant increase in physical capacity. However, ICD malfunction occurs in approximately 10% of patients. Additional tests performed by skilled medical staff and appropriate technical equipment allows the ICD program to be optimized.

[Background and evaluation plan of a study on self-management of anticoagulation in patients with non-valvular atrial fibrillation (SMAAF Study)]. / Hintergrund und Prüfplan der Studie zum Selbstmanagement der Antikoagulation bei Patienten mit nichtvalvulärem Vorhofflimmern (SMAAF-Studie).

The objective of this open, randomized, multicenter study is to investigate the benefits and economic efficiency of self-management of oral anticoagulation in patients with atrial fibrillation (SMAAF study) in comparison with a group of patients given conventional care by a general practitioner or specialist. Two thousand patients suitable for self-management will be assigned at random to either the self-management group or the control group. The numbers of thromboembolic and hemorrhagic complications requiring treatment during the 2-year follow-up period will be recorded as the primary end point. The secondary endpoint variables will be maintenance of the INR value in the individual target range, INR variance, the course of complications over time, and the cost efficiency of self-management compared with the routine procedures. The last of these parameters will include the diagnostic and/or therapeutic measures carried out, the duration of inpatient hospital treatment, and the social consequences (subsequent rehabilitation treatment, inability to work, forced retirement). The estimate of the required number of patients was based on the assumption that during long-term anticoagulant therapy within the framework of primary and secondary prevention 4% of patients with chronic non-valvular atrial fibrillation would have severe thromboembolic of hemorrhagic complications each year. Since this rate can be halved by self-management, a one-tailed chi 2-test of 80% power and a 5% significance threshold would require n = 997 patients per group. The results of the SMAAF study will establish the socioeconomic benefits of self-management in patients with non-valvular atrial fibrillation.

[Secondary prevention in coronary patients after inpation rehabilitation]. / Sekundärprävention Koronarkranker nach stationärer Rehabilitation.

BACKGROUND AND OBJECTIVE: [corrected] Data on impressive improvements in the prognosis and clinical progress of patients with coronary heart disease (CHD) through consistent reduction of risk factors and administration of cardioprotective drugs have led to the formulation of guidelines by professional associations. The aim of this prospective, multicenter cohort study (PIN: Post-Infarkt-Nachsorge = Postinfarction Aftercare) was to determine the extent to which these recommendations are implemented in the long term in patients who have had an acute coronary event and are undergoing rehabilitation therapy. PATIENTS AND METHODS: From January to May 1997, 2441 patients at 18 rehabilitation centers (22% women, 65 +/- 10 years; 78% men, 60 +/- 10 years) with diagnosed CHD following an acute cardiac event were enrolled in the study. Risk factors and pharmacologic therapy were recorded by the patients' GPs on a standardized questionnaire on admission to and discharge from rehabilitation therapy (RT) as well as after 3, 6, and 12 months. New clinical events were documented by questioning the patients and their attending physicians. RESULTS: After an impressive reduction of cardiovascular risk factors during RT, the percentage of patients with blood pressure values > 140/90 mmHg rose from 8% to 25% after 12 months (p < 0.001). 11% vs 17% of the patients had glucose levels > 140 mg/dl and 29% vs 51% had total cholesterol levels > 200 mg/dl (p < 0.001). 5% of the patients smoked at the time of discharge, 10% after one year. Compared to the time of discharge, significantly fewer beta-receptorblockers, lipid-lowering drugs, angiotensin converting-enzyme (ACE) inhibitors, and acetylsalicylic acid were prescribed. During follow-up observation, 886 patients suffered one or more clinical events, of which 69% occurred in the first six months. CONCLUSION: The interventional success of in-patient rehabilitation therapy is not sustained in the long term. This could be due to deficient implementation of guidelines for the secondary prevention of CHD, as the cardiovascular risk factors exceed pathological limits in a large proportion of patients and the prescription of cardioprotective medications is less than optimal.