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Biomedical subjects

E Grube

Publications and source records attributed to E Grube.

At least 37 records · Page 2Linked to original sources

Determinants of mortality after cardiac surgery: results of the registry of the Arbeitsgemeinschaft Leitender Kardiologischer Krankenhausärzte (ALKK) on 10 525 patients.

BACKGROUND: Mortality from cardiac surgery is an essential indicator of quality and forms the basis of treatment strategy decisions in eligible patients. No contemporary complete data on unselected adult cardiac surgery patients are available in Germany. METHODS AND RESULTS: A registry was started in June 1997 of all patients referred to surgery from 85 cardiology centres in Germany. The registry was intended to include 10 000 patients and this number was reached in March 1998. Follow-up of the patients was by simple questionnaire, reporting the date of surgery, major complications, and symptomatic improvement. If the questionnaire was not returned, a reminder letter was sent and, if necessary, further telephone investigations were performed. This resulted in 99.9% complete data. Of 10 525 patients operated on, 3.91% had died by 30 days after surgery. The overall operative mortality was 4.57%, which included 69 patients who died after more than 30 days from complications related to surgery. By multivariate analysis, the following predictors of mortality were identified: previous surgery, emergency or complex operation; age >75 years, female gender, cardiac failure, angina CCS class IV, and three-vessel coronary disease. An integral part of the registry was a pre-operative prediction of surgical risk in five categories. This risk estimate revealed a surprisingly correct prediction of the mortality observed. CONCLUSIONS: In a representative unselected group of cardiac surgery patients, operative mortality was 4.57%. Several procedural and clinical parameters were significantly correlated with mortality, but the risk increment by each of these factors was small. Unstructured clinical judgement reliably predicted the operative risk.

Aged↗

[30-day mortality after heart surgery: a pilot project of the Working Party of Directors of Hospital Cardiology Departments].

BACKGROUND AND OBJECTIVE: 30-day mortality after operation is generally accepted as a central standard of quality, especially in regard to cardiac operations. The Working Party of Directors of Hospital Cardiology Departments (Arbeitsgemeinschaft Leitender Kardiologischer Krankenhausärzte, ALKK) in Germany set up a pilot project to analyse whether by direct communication with patients by a database centre the expenditure incurred in collecting complete data can be decisively reduced and full documentation of outcome can in this way be obtained even for a large multi-centre patient cohort. PATIENTS AND METHODS: Between 1.6.1997 and 31.3.1998, data were consecutively collected by questionnaire on all patients registered for a cardiac operation at 85 of the 135 ALKK centres. The questionnaire included data about each patient and the indication for operation as well as the estimate of operative risk, assigned to one of five risk categories by the referring cardiologist either alone or in conjunction with the cardiac surgeon. RESULTS: Until 30.9.1998, the data were obtained on 11,349 patients who had given informed consent (response rate 99.99%), including survival figures. 824 (7.3%) patients had not undergone the planned cardiac surgery, 134 having died before the data of operation. The 30-day postoperative mortality, obtained in 99.99% of the 10,525 patients, was 3.92%. The operative mortality was lowest, at 3.73%, for aortocoronary bypass only (n = 7932), highest for aortocoronary bypass plus valvular operation (n = 785), at 8.04%. There was good agreement between the cardiologists' preoperative risk assessment and the observed mortality. CONCLUSIONS: The 30-day mortality after cardiac operation can be obtained almost completely and with reasonable expenditure even for a large patient cohort. The results confirm that hospital mortality data definitely understate the overall operative risk. The methodology used in this pilot project, namely the inclusion of information from the patients by questionnaire, can also be applied to clinical results in other areas.

Adult↗

Management of arterial puncture site after catheterization procedures: evaluating a suture-mediated closure device.

To overcome the challenge associated with achievement in hemostasis after a catheterization procedure, a suture-based closure device was compared with manual compression in a 600-patient randomized trial. The major study end points included the incidence of vascular complications and the time to ambulation after the procedure. The study included diagnostic or interventional procedures. The suture-mediated closure was performed immediately after the procedure independent of the anticoagulation level, whereas manual compression was performed per hospital protocol with sheath removal relying on normalization of patient's anticoagulation status. A significant reduction in time to achieve hemostasis (7.8 +/- 4.8 vs 19.6 +/- 13.2 minutes, p <0001) and time to ambulation (4.5 +/- 6.5 vs 17.8 +/- 5 hours, p <0001) was associated with use of the suture-mediated closure device. The incidence of vascular complications was similar in the overall population (5.7% for suturing device vs 11.3% for compression) or in the interventional patient subset (8.4% for suturing device vs 9.6% for compression). There was a significant reduction in the incidence of vascular complications in the diagnostic procedure subset (4.4% for suturing device vs 12.1% for compression, p <0.05). Thus, the use of a suture-mediated closure device represents a safe alternative to manual compression. Hemostasis and ambulation can be achieved faster with the suturing device than with manual compression, with a potential reduction in access site complications.

Aged↗

Final report of the European multi-center registry using the Duett vascular sealing device.

Duett, a novel vascular sealing device, was first clinically used in July 1997. A European multi-center registry was established to evaluate the safety and procedural success of the Duett sealing device in a broad range of patients undergoing diagnostic or interventional endovascular procedures. At 25 European sites 1587 patients were enrolled. All patients (> or = 18 years) must have given informed consent for the use of the sealing device after a diagnostic and/or interventional endovascular procedure performed via a femoral arterial approach. Standard length (< or = 10 cm) 5 to 9 F introducer sheaths had to be used. An ACT of < or = 400 s, and any approved GP IIb/IIIa platelet receptor antagonist was permitted. Successful deployment could be achieved in 96.2% (1526/1587 patients) with complete hemostasis within 2 to 5 minutes in over 95% of the patients. The complication-free rate was 96.4%. Arterial occlusions were rare (4 patients) and successfully treated with surgical repair in 1 and with thrombolysis in 3 patients. Pseudoaneurysms occurred in 34 patients, the majority (30/34) were successfully treated with ultrasound-guided compression or resolved spontaneously. The total rate of major complications was 2.6% (41/1587). The final results of the European registry demonstrate that the Duett sealing device can be used with a high procedural success following diagnostic and interventional endovascular procedures. The incidence of major complications is low and comparable to all other approved vascular closure devices and manual compression. CE-mark certification was approved at the end of 1998.

Adolescent↗

Laser angioplasty of restenosed coronary stents: results of a multicenter surveillance trial. The Laser Angioplasty of Restenosed Stents (LARS) Investigators.

OBJECTIVES: This study evaluated safety and efficacy of excimer laser angioplasty for treatment of restenosed or occluded coronary stents. BACKGROUND: Balloon angioplasty of in-stent restenosis is limited by a high recurrence rate. Debulking by laser angioplasty is a novel concept to treat in-stent restenosis. METHODS: A total of 440 patients with restenoses or occlusions in 527 stents were enrolled for treatment with concentric or eccentric laser catheters and adjunctive balloon angioplasty. RESULTS: Laser angioplasty success (< or =50% diameter stenosis after laser treatment or successful passage with a 2.0-mm or 1.7-mm eccentric laser catheter) was achieved in 92% of patients. Adjunctive balloon angioplasty was performed in 99%. Procedural success (laser angioplasty success followed by < or =30% stenosis with or without balloon angioplasty) was 91%. There was neither a significant difference in success with respect to lesion length, nor were there differences between small and large vessels or native vessels and vein grafts. Success was higher and residual stenosis lower using large or eccentric catheters. Serious adverse events included death (1.6%, not directly laser catheter related), Q-wave myocardial infarction (0.5%), non-Q-wave infarction (2.7%), cardiac tamponade (0.5%) and stent damage (0.5%). Perforations after laser treatment occurred in 0.9% of patients and after balloon angioplasty in 0.2%. Dissections were visible in 4.8% of patients after laser treatment and in 9.3% after balloon angioplasty. Reinterventions during hospitalization were necessary in 0.9% of patients; bypass surgery was performed in 0.2%. CONCLUSIONS: Excimer laser angioplasty with adjunctive balloon angioplasty is a safe and efficient technology to treat in-stent restenoses. These data justify a randomized comparison with balloon angioplasty.

Adult↗

Coronary stents: In vitro aspects of an angiographic and ultrasound quantification with in vivo correlation.

BACKGROUND: The validity of quantitative coronary angiography (QCA) after stent placement has been questioned because the optical density of a metallic stent, added to the density of a contrast-filled lumen, could affect border definition. METHODS AND RESULTS: We deployed 3.0- and 4.0-mm Palmaz-Schatz, Wiktor, Multilink, NIR, and InStent stents in precision-cast phantoms. Central lumens of 2.0 mm were created. There was no difference between the "true" diameters of any stented lumen by both QCA and quantitative ultrasonic (QCU) measurement poststenting. QCA systematic error (SE) varied from 0.01 for the Wiktor stents to 0.14 mm for the Palmaz-Schatz stents; the random error (RE) was 0.03 to 0.14 mm. QCU SE varied from 0.05 to 0.11 mm, and RE ranged from 0.01 to 0.07 mm. At the next stage, 4.0-mm Wiktor and Palmaz-Schatz stents were deployed into the phantom lumens; 1.5-, 2.0-, 2.5- and 3.0-mm lumens were created inside the stents. QCA and QCU measurements of 1.5- to 2.5-mm residual lumens were overestimated by 0.1 to 0.3 mm. In the 3. 0-mm residual lumen within the Wiktor stent, QCA underestimated the luminal size by -0.1 mm. There was no QCA inaccuracy for a 3.0-mm lumen within the Palmaz-Schatz stent. In patients, in 25 stented segments in both the Palmaz-Schatz and Wiktor groups, there was no difference between QCA and QCU diameters. CONCLUSIONS: QCU is sufficiently precise for the assessment of the coronary lumen after stenting. QCA can be used as an accurate method of poststent assessment, except when a very mild recurrence within a highly opaque stent is measured. In that instance, QCA may underestimate the luminal diameter.

Coronary Angiography↗

[Percutaneous suture of femoral artery access sites after diagnostic heart catheterization and or coronary intervention. Safety and effectiveness of a new arterial suture technic].

UNLABELLED: The safety and efficacy of a suture-based closure device designed to achieve hemostasis at the femoral access site post catheterization procedures was compared to manual compression in a 600 patients randomized trial (data available for 590 patients). The patients were randomized to percutaneous vascular surgery (PVS) or manual compression after diagnostic (401 patients) and interventional (189 patients) procedures. Two types of PVS devices were used delivering 1 or 2 sutures at the arterial access site. The overall results as well as the results by procedure type demonstrated a significant reduction in time of hemostasis (7.8 +/- 4.8 min vs 19.6 +/- 13.2 min, p < 0.01) and time to ambulation (4.5 +/- 6.5 hours vs 17.8 +/- 5.0 hours, p < 0.01) with the use of the PVS device. The safety results showed no significant differences in the incidence of vascular complications (5.7% for PVS vs 11.3% for compression) in the overall population or in the interventional patients subset (8.4% for PVS vs 9.6% for compression). However, the PVS device demonstrated a significant reduction in the incidence of vascular complications post diagnostic catheterization procedures (4.4 for PVS vs 12.1% for compression, p < 0.05). The incidence of vascular complications and the time of hemostasis was similar in an American multicenter study (STAND II). CONCLUSION: Percutaneous vascular surgery is a safe and effective method to achieve hemostasis post catheterization procedure providing faster hemostasis and ambulation without increasing the rate of complication.

Cardiac Catheterization↗

Effects of octreotide treatment on restenosis after coronary angioplasty: results of the VERAS study. VErringerung der Restenoserate nach Angioplastie durch ein Somatostatin-analogon.

BACKGROUND: The VERAS study (VErringerung der Restenoserate nach Angioplastie durch ein Somatostatin-analogon [Prevention of Restenosis Following Angioplasty With a Somatostatin Analogue]) was a placebo-controlled trial to evaluate the effects of octreotide for the prevention of restenosis after coronary angioplasty. Octreotide is a somatostatin analogue with antiproliferative properties on smooth muscle cell growth in vitro that limits myointimal thickening of arteries in balloon injury models. METHODS AND RESULTS: Patients received either octreotide or placebo, starting 1 hour before angioplasty and continued for 3 weeks. The minimal luminal diameters before and after angioplasty and at 6-month follow-up were analyzed with a digital quantitative algorithm. Of the initial 274 patients recruited, 217 (108 in the octreotide group and 109 in the placebo group) could be analyzed after a complete 6-month evaluation: the minimal luminal diameters were 1.67+/-0.57 mm in the octreotide-treated group and 1.66+/-0.64 mm in the placebo group (two-paired P=.70), and the relative losses were 0.16+/-0.22 and 0.13+/-0.21 (two-paired P=.27). The restenosis rates were also identical in both treatment groups: final diameter stenosis > or =50% (34.3% versus 33.9%, two-paired P=1.0), loss of > or =50% of the initial gain (34.3% versus 33.9%, two-paired P=1.0), and absolute reduction of minimal luminal diameter >0.72 mm (29.6% versus 24.8%, two-paired P=.45). Likewise, there was no difference with regard to the incidence of clinical events (death, myocardial infarction, bypass operations, reintervention). Octreotide was well tolerated, with the exception of gastrointestinal side effects, which were three times more common than in the placebo group. CONCLUSIONS: Octreotide did not reduce the angiographically determined restenosis rate or the incidence of major clinical events after coronary angioplasty.

Adult↗

[Percutaneous suture closure of the femoral artery access after diagnostic heart catheter examination or coronary intervention].

BACKGROUND AND OBJECTIVE: Alternative methods to the conventional one of external compression with a pressure bandage over the site of arterial puncture after percutaneous catheter introduction for coronary angiography or transluminal balloon coronary angioplasty have failed to reduce the rate of vascular complications. This study was undertaken to assess the complication rate of a percutaneously introduced suturing device (Techstar, Perclose). PATIENTS AND METHODS: To achieve immediate haemostasis and thus shorten post-interventional immobilisation the technique of percutaneous suturing of the femoral artery was used in 1030 consecutive patients (793 men, 237 women; mean age 58.6 years) without obstructive vascular disease or local vascular complications. RESULTS: Percutaneous suture closure with primary haemostasis was successful after 137 of 153 coronary angioplasties (89.5%) and after 786 of 977 left heart catheterisations (89.6%). Early mobilisation, after at most 4 hours, was possible in 923 patients with successful suture closure (89.6%). The overall complication rate was 0.78%. CONCLUSION: Percutaneous suture repair of the femoral artery after cardiac catheterisation is a safe and effective method to achieve immediate haemostasis. However, controlled studies are needed to demonstrate harmlessness of early mobilisation.

Angioplasty, Balloon, Coronary↗

Safety of transesophageal echocardiography. A multicenter survey of 10,419 examinations.

BACKGROUND: During the past few years, transesophageal echocardiography (TEE) has been increasingly used in clinical cardiology; data concerning the practicability and safety of the technique, however, are rare. METHODS AND RESULTS: This report analyzes the experience of 15 European centers performing TEE studies for at least 1 year. At the time of this survey, 10,419 TEE examinations had been attempted or performed in these institutions. These TEE examinations were carried out by 54 physicians, 53.7% of whom had been trained in endoscopic techniques. Within the same time period, 160,431 precordial echocardiographic examinations were performed in the 15 institutions; the ratio between TEE and transthoracic studies averaged 9.03 +/- 6.4% (range of the 15 centers, 1.4-23.6%). Of the 10,419 patients, 9,240 (88.7%) were conscious inpatients or outpatients at the time of the TEE examination; the vast majority of the conscious patients did not receive intravenous sedation before TEE. In 201 cases (1.9%), insertion of the TEE probe was unsuccessfully attempted because of a lack of patient cooperation and/or operator experience (98.5%) or because of anatomical reasons (1.5%). In 90 of 10,218 TEE studies (0.88%) with successful probe insertion, the examination had to be interrupted because of the patient's intolerance of the echoscope (65 cases); because of pulmonary (eight cases), cardiac (eight cases), or bleeding complications (two cases); or for other reasons (seven cases). One of the bleeding complications resulted from a malignant lung tumor with esophageal infiltration and was fatal (mortality rate, 0.0098%). CONCLUSIONS: This multicenter survey documents that TEE studies are associated with an acceptable low risk when used by experienced operators under proper safety conditions.

Data Collection↗

[Cardiomyopathy in progressive muscular dystrophy].

A dilated cardiomyopathy with clear signs of left-ventricular functional abnormalities occurred in a 21-year-old man with known Duchenne's progressive muscular dystrophy. Echocardiography and magnetic resonance imaging delineated the regional disorder of ventricular wall motion and defined its segmental extent. With neither method was it possible to analyse texture with demonstration of differential regional involvement. As a noninvasive method echocardiography is suitable for diagnosing Duchenne's cardiomyopathy and monitoring its progression.

Adult↗

[Significance of microproteinuria for early detection of hypertension-induced end organ damage].

To investigate the clinical importance of microproteinuria, we examined the prevalence of microproteinuria and its relation to cardiac structural adaptation in 80 male, middle-aged patients with essential hypertension. Patients with secondary causes of hypertension were ruled out. 14 out of 80 hypertensives (18 percent) were found to have microproteinuria defined as "negative" for urinary protein excretion in the conventional test, but "positive" (above the upper normal limit) in the 24-hour urine samples. Patients with microproteinuria had a similar age and body weight, but a higher systolic and diastolic pressure (161 +/- 14/104 +/- 12 vs 148 +/- 14/97 +/- 9 mmHg, p less than 0.02) and greater creatinine clearance (163 +/- 36 vs 136 +/- 33 ml/min, p less than 0.01) than those with normal protein excretion. Also, hypertensives with microproteinuria had a greater left ventricular mass (241 +/- 57 vs 207 +/- 45 g, p less than 0.05) and greater cross sectional area (22.2 +/- 2.8 vs 20.5 +/- 2.9 cm2, p less than 0.05) evaluated by 2-D guided M-mode echocardiography than the control group. A positive Sokolow-index was more prevalent in patients with microproteinuria than in those without (x2 = 6.2, p less than 0.02). Patients with essential hypertension and microproteinuria (prevalence 21 per cent) were characterized by a higher arterial pressure, by a higher degree of echocardiographic and electrographic evidence of left ventricular hypertrophy. Thus, microproteinuria might serve as a marker for early target organ damage in essential hypertension.

Adult↗

Relation of hemodynamic reaction during stress to left ventricular hypertrophy in essential hypertension.

To elucidate the impact of increased afterload during physical and mental stress on myocardial hypertrophy, a homogeneous population of 73 patients with untreated mild-to-moderate essential hypertension were enrolled in the current study. Left ventricular mass and cross-sectional area, both determined by 2-D guided M-mode echocardiography, were related to blood pressure measured at rest as well as during various stress situations. Left ventricular mass and cross-sectional area correlated with systolic pressure at work site (r = 0.28 and r = 0.23 respectively, P less than .05) and systolic pressure at complete rest (r = 0.35 and r = 0.33, P less than .01). Neither the response in blood pressure to mental arithmetic or a bicycle exercise test performed in the laboratory, nor blood pressure during both stress tests were significantly related to the degree of left ventricular hypertrophy. In addition, patients with a hyperreactive response to mental arithmetic or to the physical stress test did not disclose a greater left ventricular mass than normoreactors. Examining the hemodynamic response pattern during mental arithmetic, we found that patients with vasoconstriction during mental stress had a greater left ventricular mass than individuals with vasodilation during mental stress (244 +/- 73 v 204 +/- 53 g, P less than .05), but this was due to the impact of obesity on left ventricular mass (analysis of covariance: F = 2.1, P = NS). Thus, blood pressure at work site and at rest, but not blood pressure during mental or physical stress, nor the response of blood pressure to both stress tests, was linked to the degree of left ventricular hypertrophy.(ABSTRACT TRUNCATED AT 250 WORDS)

Cardiomegaly↗

[Determinants for myocardial hypertrophy in mild essential hypertension. The effect of sodium chloride on left-ventricular hypertrophy].

The impact of clinical parameters on the pathogenesis of myocardial hypertrophy was examined in 75 male patients with mild essential hypertension. Clinical parameters were age, body weight, sodium excretion (as an estimate for dietary salt intake), systolic and diastolic blood pressure at work, casual blood pressure, resting and stress blood pressure during mental stress test and physical exercise. Left ventricular mass as a parameter for the degree of left ventricular hypertrophy was assessed by 2-D guided M-mode echocardiography. Left ventricular mass correlated with body weight (r = 0.47, p less than 0.002), with body mass index (r = 0.48, p less than 0.001), with systolic blood pressure at the worksite (r = 0.28, p less than or equal to 0.05), and systolic blood pressure at rest (r = 0.35, p less than or equal to 0.01), whereas no correlation was found between casual or stress blood pressure readings during physical exercise and mental stress with the degree of left ventricular hypertrophy. Sodium excretion was related to the end-diastolic diameter of the left ventricle (r = 0.33, p less than or equal to 0.01) and to left ventricular mass (r = 0.35, p less than or equal to 0.01). Multiple regression analysis revealed that sodium excretion over 24 hours, systolic blood pressure at the worksite and body mass index were independent determinants of left ventricular mass. Thus, dietary salt intake was found to modulate the degree of left ventricular hypertrophy independently of the pressure load imposed on the myocardium.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗

Pharmacokinetic and pharmacodynamic properties of ramipril in patients with congestive heart failure (NYHA III-IV).

To investigate the pharmacokinetics and pharmacodynamics of a new angiotensin converting enzyme (ACE) inhibitor, ramipril (HOE 498), in patients with cardiac insufficiency (NYHA III-IV), we performed an open trial with a follow-up of 10 days. Twenty-seven patients (18 females, 9 males), mean aged 62 years (46-83) with severe heart failure, were included. After a single oral dose of 5 mg ramipril, the plasma and urine levels of ramipril, ramiprilat, ACE plasma activity, standard laboratory values, blood pressure and pulse rate were evaluated. The maximal plasma level of ramipril was 57.0 +/- 26.8 ng/ml after 1.4 h; t1/2 was 2.4 +/- 1.2 h. The peak level of ramiprilat was 27.9 +/- 24 ng/ml after 4.6 h; t1/2 for the active compound was 6 +/- 4.2 h. The total recovery of ramipril and metabolites in urine was on average 39 +/- 17.5% within 96 h. Ninety-five percent inhibition of ACE activity was observed in all patients and 80% inhibition lasted 24 h. Systolic and diastolic blood pressure decreased without changes in heart rate. Five patients had mild side effects: hypotension, diarrhea, and dizziness. In conclusion, in patients with severe heart failure, plasma levels of drug and active metabolite were higher and remained measurable longer, with more sustained inhibition of ACE activity than reported in healthy volunteers. This indicates that titration should start with lower doses (1.25-2.5 mg) and that doses above 5 mg may rarely be necessary.

Administration, Oral↗

[Assessment of the severity of mitral valve insufficiency using color Doppler echocardiography].

UNLABELLED: To evaluate different methods for quantification, 55 adult patients with mitral insufficiency were investigated by Doppler color flow mapping (CFM). The maximal area, length and width of the regurgitant jet were determined using apical windows and these were then related to the angiographic findings (Sellers I-IV). In 11/55 patients reliable tracing of the regurgitant flow was not possible because of drop-outs and impaired signal-to-noise ratio. With none of the three systems was a reliable differentiation of moderate to severe forms of mitral incompetence possible because of wide overlapping of the CFM-values in the four angiographic classes. Relating the CFM-values to the diameter or area of the left atrium did not improve the correlations with the angiographic data. At best, the measurement of the maximal area allowed an approximate estimation of the degree of insufficiency: values greater than 6.5 cm2 were not found in patients with Sellers class I or II. Results below this limit could be found in all four angiographic classes. The variability for the estimation of the maximum area (linear regression analysis) was r = 0.96, SEE = 0.07 (intraobserver) and r = 0.94, SEE = 0.08 (interobserver). CONCLUSION: CFM is not a reliable method for classification of mitral regurgitation.

Blood Flow Velocity↗