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Biomedical subjects

H Heidrich

Publications and source records attributed to H Heidrich.

At least 19 recordsLinked to original sources

Complete ulcer healing as primary endpoint in studies on critical limb ischemia? A critical reappraisal.

OBJECTIVES: Although complete ulcer healing is the mandatory primary efficacy criterion in current European guidelines for drug trials in critical limb ischemia (CLI), the appropriateness of this endpoint has been questioned for some time. We carried out a systematic review to assess the value of this endpoint in studies on reconstructive measures, considered to be the standard of care for CLI. METHODS: A computerized literature search (1985-2005) was performed to track down clinical studies on endovascular and surgical interventions by using the search terms CLI and ulcer healing and their synonyms. RESULTS: 1,914 papers on revascularization in CLI were identified. Complete ulcer healing was reported in 17 studies (0.9%). Among these, there were no randomized controlled trials, five prospective cohorts on endovascular procedures, and six retrospective cohorts for endovascular and surgical procedures, respectively. If healing rates or time to ulcer healing were available, they differed greatly between the studies without consistent correlation to types of therapy. CONCLUSIONS: In past and current literature, complete ulcer healing is not a consistently reported criterion for success of revascularization in CLI. Thus, its appropriateness for efficacy assessment of drug studies in CLI patients has to be questioned.

Diabetic Angiopathies↗

Concomitant neurological and orthopaedic diseases in the presence of peripheral arterial disease: a prospective study.

BACKGROUND: The symptoms of peripheral arterial disease (PAD) can be masked by neurological or orthopaedic diseases with identical symptoms, which may result in faulty therapy decisions, if the diagnosis is solely based on the reported complaints and angiographic or duplex ultrasonographic findings. A prospective study was therefore performed to find out how often established PAD is accompanied by neurological or orthopaedic pictures that can blend into the PAD symptoms. PATIENTS AND METHODS: The examination was performed in 235 patients with PAD of Fontaine's stages II to IV, 125 were women and 110 men; the mean age was 71 years (41 to 95 years). They were systematically examined for angiologic, neurological and orthopaedic diseases. RESULTS: 44% of the patients enrolled in the study suffered from a neurological disease, 45% from an orthopaedic disease and 24.7% from both a neurological and an orthopaedic disease. The frequency of concomitant diseases depended on the stage of PAD. In Fontaine's stage II, alterations due to arthrosis or arthritis were found in 12% of the patients, peripheral neuropathies in 14%, radiculoneuropathies in 16% and malpositions of the foot in 16%. In Fontaine's stage III, arthrosis and arthritis were predominant at a percentage of 38.5%; peripheral neuropathies were diagnosed in 15.4% of the patients. Patients with Fontaine's stage IV most often showed peripheral polyneuropathies at 42.1% and malpositions of the foot at 28.4%. CONCLUSIONS: Because of the frequency of neurological and orthopaedic pictures with identical symptoms, a differential diagnosis before the initiation of a PAD therapy is imperative.

Adult↗

[Vasoactive agents and prostanoids in the therapy of PAD: facts, questions, disproven assumptions].

In the view of the AkdA (Drug Committee of the German Medical Profession), the efficacy in intermittent claudication is currently proven only for Naftidrofuryl, whereas in the opinion of the DGA (German Society of Angiology) also that of prostaglandin E(1) is proven. Both drugs are indicated if neither walking exercise nor vascular or endovascular reconstruction are feasible. In critical limb ischaemia (Fontaine stage III/IV), the efficacy of prostaglandin E(1) and iloprost is proven according to both the treatment recommendations of the DGA and the ACC/AHA Guidelines. The AkdA also agrees with the administration of prostanoids, even though it considers their efficacy not sufficiently proven in accordance with CPMP criteria. Here, prostaglandin E(1) is approved for the treatment of Fontaine's stage III/IV regardless of its etiology, whereas iloprost is approved only for the treatment of thrombo-angiitis obliterans.

Arterial Occlusive Diseases↗

Prostaglandin E1 infusion therapy in dry age-related macular degeneration.

OBJECTIVE: The pilot study is intended to show whether prostaglandin E1 (PGE1) infusions are able to stop the gradual vision loss in dry age-related macular degeneration (AMD) and, further, to stabilize or improve visual acuity. METHODS: With PGE1 infusions 11 patients with different forms of dry AMD were treated and compared with a control group of 10 untreated patients with dry AMD. The target parameter was the visual acuity, as determined with the ETDRS logMAR charts. Other examinations performed during the study were tests of contrast vision, colour vision and central visual fields, as well as autofluorescence and fluorescein angiography and multifocal electroretinography. RESULTS: On termination of the infusions, six patients showed an increase in visual acuity by at least one line, an improvement that was seen in eight patients 2 months after the end of the infusion therapy. After 6 months, one patient exhibited an improvement of visual acuity by three lines and three patients an improvement by one line. Five patients were found to show no change of their baseline acuity values after 6 months, while two patients exhibited an impairment by one line. The visual acuity in the dry AMD control group without PGE1 treatment had decreased by 0.8 lines on the average after 6 months. Contrast vision, central visual fields and the multifocal electroretinogram showed improvements on the termination of infusions and up to 2 months later; no substantial change of these parameters, as compared with the baseline findings, was seen 6 months after the termination of infusions. SUMMARY: This pilot study suggests that PGE1 infusions have a stabilizing or improving effect on the visual acuity of patients with dry AMD. Owing to the limitations of a pilot study, these results should, however, be validated in a larger, randomized and blinded study.

Aged↗

Are there predictors for the outcome of a PGE1 treatment in peripheral arterial disease with critical limb ischaemia?

BACKGROUND: In a multivariate retrospective analysis was conducted to examine whether and to what extent PGE1 is therapeutically effective and whether there are predictors of response. PATIENTS AND METHODS: The examination included 767 patients (448 women, 319 men) of a mean age of 71.2 years and with peripheral arterial disease (PAD) having existed for 44.7 months on the average. They suffered from critical limb ischaemia (Fontaine's stages III/IV) and showed average tcpO2 values at the instep of 2 mmHg (0 to 15) and average systolic malleolar artery pressures of 18 mmHg (0 to 35 mmHg). Between 1989 and 2001, the patients had received treatments in hospital with i.v. PGE1 doses (2x20 microg or 1x60 microg/day) for an average of 34.2 days (mean of responder- and non-responder group). Patients were called responders when pain had markedly decreased or disappeared, necroses had been reduced or healed completely, and vascular reconstruction, PTA or amputations were not necessary. RESULTS: The clinical analysis showed 82.4% of the patients to be responders and 17.6% to be non-responders. It was demonstrated that the outcome of the therapy was not dependent on the supine or sitting tcpO2, the malleolar artery pressure, the patient's age or sex, the duration of PAD, the number or kind of concomitant diseases, the patient's general condition, the localization and number of vascular occlusions, the kind of prior therapy, or the number of previous amputations, although differences in some of the parameters, while clinically irrelevant, were found to be statistically significant. They are not predictors of the outcome of a PGE, therapy. CONCLUSIONS: Even in extremely bad haemodynamic situations at the beginning of a therapy (malleolar artery pressures from 0 to 35 mmHg, tcpO2 0 to 15 mmHg, multilevel occlusive disease, multiple previous operations and concomitant diseases), PGE, therapies of more than 20 days - on the average 35.6 days (mean of responder group) - duration allow clinically relevant positive results to be achieved.

Age Distribution↗

Frequency of asymptomatic peripheral arterial disease in patients entering the department of general and internal medicine of a general-care hospital.

BACKGROUND: The fact that a high prevalence of asymptomatic peripheral arterial disease (PAD) in the population has repeatedly been noted in recent years, without there being data as to how often asymptomatic PAD has to be anticipated in inpatients treated for divergent internal diseases led us now to performing a screening study in a general-care hospital. PATIENTS AND METHODS: The study population consisted of 990 patients (51.8% women, 48.2% men) with a mean age of 65.2 years (40-93 years) who had to be treated in a hospital for various internal diseases in the period from January 1994 to January 1995. Their case histories were taken, and their clinical findings and the ankle/brachial indices as calculated from Doppler ultrasonographic measurements of the systolic pressures in the malleolar and brachial arteries were used to ascertain how many of the patients presented with asymptomatic and symptomatic PAD. Further the frequency of risk factors (smoking, hypertension, diabetes mellitus, lipid disorders) was recorded for either patient group. RESULTS: The study showed that 6% of the 990 patients suffered from symptomatic PAD and that of the remaining 931 patients, 43.7% were diagnosed, on the basis of the ankle/brachial index (ABI) (< or = 0.9), to have asymptomatic PAD, while 56.3% showed no indication of PAD. CONCLUSIONS: The high number of cases of asymptomatic PAD among inpatients who underwent internal treatment--a percentage well above the figures published so far for outpatients--allows the conclusion that the determination of the ABI is well suited to screen patients older than 50 years even in a hospital setting so that early secondary prophylaxis can be initiated.

Adult↗

Frequency of non-vascular accompanying diseases in patients with peripheral arterial disease.

BACKGROUND: Since there are so far no relevant figures on the frequency of non-vascular associated diseases in patients with peripheral arterial disease (PAD), an analysis was carried out to determine how frequently co-morbidity is found in such patients. PATIENTS AND METHODS: In the course of a retrospective analysis, 1693 patients (55.4% men, 44.6% women/average 68.6years) with peripheral arterial diseases (PAD) of Fontaine stage II to IV were examined to find out how often cardiopulmonary, gastrointestinal, haematological, endocrinological, neurological, orthopaedic, urological-nephrological, psychiatric diseases and tumours were seen. RESULT: Coronary ischaemic heart disease was present in 63.1% of the cases, heart failure existed in 20.7%, hypertension in 57.9%, endocrine and metabolic diseases in 60.4%, gastrointestinal diseases in 14.8%, pulmonary diseases in 14.5%, psychological and behavioural deficiencies in 16.2%, orthopaedic diseases in 21.6%, haematological diseases in 9.0%, urological diseases in 16.9%, chronic renal insufficiency in 7.3% and malignant tumours in 5.8%. CONCLUSIONS: The frequency of non-vascular comorbidity in patients with PAD necessitates systematic interdisciplinary diagnosis prior to any therapy decision to take into account the patient's associated diseases, life expectancy and current quality of life.

Aged↗

Hemostatic and fibrinolytic effects of systemic prostaglandin E1 therapy in patients with peripheral arterial disease.

BACKGROUND: The study was designed to evaluate if there is any evidence of a hyperfibrinolytic bleeding-risk under systemic treatment with prostaglandin E1 (PGE1) of patients with peripheral arterial disease (PAD). PATIENTS AND METHODS: The in vivo effect of PGE1 on the fibrinolytic and hemostatic process was tested on 15 patients before and after treatment with Alprostadil for 21 days using D-dimers (DD), fibrinogen, prothrombin time (PT), partial thromboplastin time (PTT), antithrombin (AT), ProC-Global, plasminogen, plasminogen activator inhibitor activity (PAI), alpha 2-antiplasmin, coagulation factor XII, basal and activated fibrinolytic capacity (fib. cap.). RESULTS: There was no significant difference in DD, fibrinogen, PT, PTT, AT, ProC-Global, plasminogen, PAI, alpha 2-antiplasmin, coagulation factor XII, basal and activated fibrinolytic capacity observed after the treatment. CONCLUSION: Summarizing this study there is no hyperfibrinolytic bleeding-risk after the systemic therapy with Alprostadil to be expected.

Aged↗

[DRG-based cost analysis of inpatient conservative treatment of stage III/IV peripheral arterial occlusive disease].

UNLABELLED: DRG-based cost analysis of inpatient conservative treatment of PAD stage III/IV BACKGROUND: In a prospective study carried out by the German Society of Angiology and the DRG Competence Center, Munich, the question was investigated whether the costs of conservative treatment of patients with PAOD stage III/IV (DRG F65) are adequately represented within the current G-DRG system. METHODS UND PATIENTS: Between September 1 and December 16, 2002, a total of 704 patients with DRG F65 (peripheral vascular diseases) were evaluated at 8 angiologic centers in Germany. Apart from the length of hospital stay, the total costs (cost equivalents) were calculated using a method developed by the DRG Research Group at the University of Münster. Moreover, the study population was compared with a German calculation sample for the DRGs F65A/B, as published by InEK. RESULTS: As it turned out, conservatively treated patients with PAOD stage III or IV (DRGs F65A/B) cause significantly (p < 0.001) higher costs and have significantly (p < 0.001) greater lengths of hospital stay than patients who were also assigned to DRG F65 because of other vascular diseases. At the same time it became clear that angiologic centers treat twice as many patients with critical limb ischemia in comparison with the German average. The reimbursement hitherto estimated by InEK covers not even half the cost actually produced by conservative treatment of PAD stage III/IV. CONCLUSION: To ensure a performance-related reimbursement, a new basis DRG for patients with PAD stage III/IV has to be created, as has ben proposed by the German Society of Angiology. Otherwise, adequate conservative therapy in accordance with existing guidelines, of patients who cannot be treated surgically or interventionally will not be possible any more in the future.

Arterial Occlusive Diseases↗

Vital capillary microscopic findings in the nailfold of patients with diabetes mellitus.

BACKGROUND: Preliminary investigation done in 100 healthy adults and 20 healthy children had shown that the interpretation of significance of changes in capillary morphology need to be corrected, since capillary changes previously considered to be pathological are also to be found in large numbers in healthy subjects. Against this background, the question has now been investigated whether the capillary microscopic findings in diabetics deviates from those found in normals, and whether the duration of the diabetes, its treatment, its sequelae, or concomitant diseases have any influence on the capillary microscopic appearance. PATIENTS AND METHODS: In 100 patients aged between 44 and 88 years with type 2 diabetes vital capillary microscopy was carried out on all ten fingers in the usual manner. The evaluation of the video recordings was done only when all the examinations had been completed--by two examiners blinded to the clinical data. RESULTS: It was shown that 66% of the patients demonstrated pathological capillary microscopic findings. These findings included pathologically increased apical and non-apical dilatations (32%), haemorrhagic extravasations (20%) and branchings (45%). No differences were found between the therapy groups (insulin--oral medication) nor was any relationship between the appearance of capillary changes and the duration of diabetes observed. Diabetics with concomitant diabetic sequelae (polyneuropathy), demonstrated no differences in capillary morphology as compared with diabetics with no such sequelae. CONCLUSION: Diabetics are found to have an increased incidence of pathological capillary morphology taking the form of increased apical dilatations, branchings and haemorrhagic extravasations. Neither the treatment, nor the duration of the illness, nor diabetic sequelae appeared to have any influence on the capillary microscopic changes.

Adult↗

[What is the value of determining walking distance in peripheral arterial occlusive disease on the treadmill and in daily life? Prospective correlation study].

AIM: To investigate the question whether and how walking distances measured under standardized conditions on the treadmill and on the level correlate with the patients walking ability under everyday conditions. PATIENTS AND METHOD: In 49 patients (33 men, 16 women, age 34 to 84 years) with Fontaine Stage II peripheral arterial occlusive disease the pain-free and absolute walking distance on the treadmill were measured under standardized conditions, as also the walking distance on the level at freely selected speed. RESULT: It was found that the pain-free walking distance under everyday conditions was about 2 to 3 times longer than that measured under standardized conditions on the treadmill.

Adult↗

Randomized reliability study evaluating constant-load and graded-exercise treadmill test for intermittent claudication.

The aim of this randomized study was to compare the reliability of the treadmill test at constant-load (C-test, 3 km/hr; fixed grade of 12%) recommended in Germany with that of the graded-exercise test (G-test, 3 km/hr; increase in grade of 3.5% every 3 minutes) propagated in the United States. In 50 patients with an absolute claudication distance (ACD) in the C-test of between 50 and 400 m, the two treadmill tests were carried out in randomized order on one and the same day, and repeated on 3 days within 1 week. For the initial claudication distance (ICD), the intraclass correlation was 0.88 in the C-test and 0.87 in the G-test. For the ACD the coefficients were identical at 0.91. The within-subject variation (CVwithin) in the C-test and G-test was 25% and 27% for the ICD and for the ACD 24% and 21%, respectively. The between-subject variation was very similar with 72% and 73% (ICD) and with 78% and 68% (ACD). However, in ACDs below 100 m and between 100 to 150 m, the C-test showed significantly smaller coefficients of variation than the G-test: 13% vs 81% and 14% vs 50%, respectively. In conclusion, the results showed that both C-test and G-test are equally well reproducible.

Analysis of Variance↗

[Heparin-induced thrombocytopenia with unfractionated heparin. A prospective study of inpatient treatment of internal medicine patients].

AIM: To investigate the influence of unfractionated heparin on heparin-induced thrombocytopenia (HIT) type II. PATIENTS AND METHOD: In 162 patients with internal diseases treated therapeutically of prophylactically with unfractionated heparin (heparin sodium, heparin calcium), we carried out a prospective study to determine the incidence of HIT type I and II. 55.6% of the patients were female (n = 90) with an average age of 76.5 years (range: 25 to 96 years) and 44.4% male (n = 72) with an average age of 67.5 years (range: 17 to 93 years). A platelet count was taken regularly before the start of heparin treatment, on the first day of treatment and then every second day from day 5 to 20. Whenever HIT II was suspected, an HIPA test was performed. RESULT: Type I HIT occurred in 10%, type II in 3% of the cases. Two of the 5 patients with type II developed severe thrombotic complications. CONCLUSION: In view of the high incidence of HIT, regular platelet counts should always be carried out in patients receiving heparin treatment.

Adult↗

The Incidence of Occult Malignant Diseases in Patients With Deep Venous Thrombosis of the Pelvis and Lower Limb

In 318 patients (155 men, 163 women) with an average age of 58.8 years (range 16-97 years), a retrospective study was carried out to determine the incidence of occult malignancies in patients with deep venous thrombosis affecting the pelvis and lower limb, confirmed by phlebography or duplex ultrasonography. It was found that, overall, 7.5% of all patients had occult malignant diseases, the most common being bronchial carcinoma (16%), colonic and renal carcinomas (12% each), and prostatic and pancreatic carcinoma (8% each). Of the patients with occult malignancy, 88% were older than 55 years. This fact shows that acute phlebothromboses may be a paraneoplastic early syndrome more often than was previously thought, and that patients older than 50 should always be screened for the presence of a tumor.

Journal Article↗

The Incidence of Heparin-Induced Thrombocytopenias

The incidence of heparin-induced thrombocytopenia (HIT) types I and II was investigated retrospectively in 500 heparin-treated patients. In our department of internal medicine 500 patients were treated with unfractionated, middle- or low-molecular heparin (s.c. or i.v.) during 1995 as inpatients. Excluded were patients with other known causes of thrombocytopenia. There were 306 females (61%), mean age 76 years (17-98 years) and 194 males (39%), mean age 73 years (24-93 years). The incidence of HI type I was 4.4% and of HIT type II 0.6% with a positive heparin-induced-platelet-activation test (HIPA test). In addition, HIT type II was suspected in another 1.4% of cases with negative or missing HIPA test. Because of our results on the incidence of HIT type I and type II a close control of thrombocyte count during heparin therapy is necessary. In the case of HIT type II disease, heparin therapy must be stopped immediately.

Journal Article↗