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Biomedical subjects

H Emanuelsson

Publications and source records attributed to H Emanuelsson.

At least 55 records · Page 3Linked to original sources
PubMed1996

Heparin-coated Palmaz-Schatz stents in human coronary arteries. Early outcome of the Benestent-II Pilot Study.

BACKGROUND: The purpose of the Benestent-II Pilot Study was to evaluate the safety of delaying and eliminating anticoagulant therapy in patients receiving a heparin-coated stent in conjunction with antiplatelet drugs. METHODS AND RESULTS: The study consisted of three initial phases (I, II, III) during which resumption of heparin therapy after sheath removal was progressively deferred by 6, 12, and 36 hours. In phase IV, coumadin and heparin were replaced by 250 mg ticlopidine and 100 mg aspirin. Of the 207 patients with stable angina pectoris and a de novo lesion in whom heparin-coated stent implantation was attempted, implantation was successful in 202 patients (98%). Stent thrombosis did not occur during all four phases, and the overall clinical success rate at discharge was 99%. Bleeding complications requiring blood transfusion or surgery fell from 7.9% in phase I to 5.9%, 4%, and 0% in the three following phases. Hospital stay was 7.4, 6.1, 7.2, and 3.1 days for the consecutive phases. The restenosis rate for the combined four phases was 13% (15% in phase I, 20% in phase II, 11% in phase III, and 6% in phase IV). The overall rate of reintervention for the four phases was 8.9%. At 6 months, 84%, 75%, 94%, and 92% of the patients of phases I to IV, respectively, were event free. For the four phases, the event-free rate was 86%, which compares favorably with the rate observed in the Benestent-I study (80%; relative risk, 0.68 [0.45 to 1.04]). CONCLUSIONS: The implantation of stents coated with polyamine and end-point-attached heparin in stable patients with one significant de novo coronary lesion is well tolerated, is associated with no (sub)acute stent thrombosis, and results in a favorable event-free survival after 6 months.

Aspirin↗
PubMed1996

Effects of a new calcium antagonist, mibefradil (Ro 40-5967), on silent ischemia in patients with stable chronic angina pectoris: a multicenter placebo-controlled study. The Mibefradil International Study Group.

OBJECTIVES: The purpose of this study was to evaluate the effects of mibefradil (Ro 40-5967) on the frequency and duration of episodes of asymptomatic ischemia in patients with stable angina pectoris and to determine the most efficient single therapeutic dose of this drug. BACKGROUND: Mibefradil is a novel calcium channel antagonist that shows a high bioavailability, induces no reflex tachycardia and has no negative inotropic effects. METHODS: In a multicenter, double-blind, placebo-controlled, parallel-design trial, 126 patients with chronic stable angina pectoris were studied. After 1 week of a placebo run-in period, patients were randomized to receive 25, 50, 100, 150 mg of mibefradil or placebo for 2 weeks. Ambulatory 48-h electrocardiographic (ECG) monitoring was performed at the end of both the placebo run-in period and the active treatment period. RESULTS: Compared with placebo, mibefradil was associated with significantly less ischemia as manifested during ambulatory ECG monitoring. In the 150- and 100-mg groups, respectively, the drug resulted in a 73% and 63% reduction in the frequency of episodes of ST segment depression and a 78% and 58% reduction in the total duration of ST segment depression. Highly significant linear dose-response relations were present across all treatment groups for ischemic episodes and ischemia duration (p < 0.001). Electrocardiographic abnormalities related to treatment were first-degree atrioventricular block, sinus bradycardia and short Wenckebach episodes, observed during sleep on Holter monitoring. All ECG events were dose related. CONCLUSIONS: Mibefradil is a new, safe, well tolerated and very effective dose-dependent anti-ischemic calcium channel antagonist.

Angina Pectoris↗
PubMed1996

Angina pectoris treated by thoracoscopic sympathecotomy.

Open surgical sympathectomy has previously been shown effective in relieving severe angina pectoris. The method was hampered by high morbidity and mortality. The authors have developed a minimally invasive technique of dividing only the sympathetic chain endoscopically and obtained good results with no serious complications in patients operated on for severe palmar hyperhidrosis. This method was used in 43 patients with severe angina pectoris who were not eligible for coronary artery bypass grafting or percutaneous transluminal coronary angioplasty. There was no mortality or any severe complications. Some 19 patients became symptom-free while 22 were improved and two unchanged after surgery. The frequency of anginal attacks was significantly reduced, as was the consumption of nitroglycerine tablets. The maximum exercise capacity was significantly increased and ST-segment depression reduced.

Aged↗
PubMed1996

Mortality and morbidity during a period of 2 years after coronary artery bypass surgery in patients with and without a history of hypertension.

OBJECTIVE: To describe mortality and morbidity during a period of 2 years after coronary artery bypass grafting (CABG) in relation to a history of hypertension. PATIENTS: All patients in western Sweden in whom CABG was undertaken between June 1988 and June 1991 and in whom simultaneous valve surgery was not performed were included in the study. DESIGN: A prospective 2-year follow-up study. RESULTS: Patients with a history of hypertension (n = 777) differed from patients without such a history (n = 1348) in that the proportion of women was higher, they were older and more frequently had a history of congestive heart failure, diabetes mellitus, renal dysfunction, cerebro-vascular disease, intermittent claudication and obesity, and the number of smokers and patients with previous CABG was lower. They were also more likely to develop post-operative cerebrovascular complications and signs of myocardia damage. Patients with hypertension tended to have increased mortality during the first 30 days after CABG and the late mortality (between day 30 and 2 years) was significantly higher than in non-hypertensive participants. Whereas the development of myocardial infarction was similar in both groups, the hypertensive study participants more frequently developed stroke during 2 years of follow-up. In a multivariate analysis including age, sex, history of different cardiovascular diseases, smoking, ejection fraction, and the occurrence of three-vessel disease, hypertension did not emerge as an independent predictor of death in the early or late phase or during a total of 2 years of follow-up. CONCLUSION: Among CABG patients, those with a history of hypertension have a different pattern of risk factors. They have a higher mean age, include a higher proportion of women and have a higher prevalence of congestive heart failure, diabetes mellitus, renal dysfunction, cerebro-vascular disease, intermittent claudication, and obesity. They also have an increased frequency of immediate post-operative complications and an increased 2-year mortality, even if a history of hypertension was not an independent predictor of death during 2 years of follow-up.

Blood Pressure↗
PubMed1996

Thrombin inhibition with inogatran for unstable angina pectoris: evidence for reactivated ischaemia after cessation of short-term treatment.

BACKGROUND: The acute coronary syndromes of unstable angina and non-Q-wave infarction are initiated by coronary plaque rupture and subsequent thrombus formation. Thrombin is central to this response as it activates platelets and the coagulation system. In an open design study we assessed the tolerability and safety of the low molecular weight thrombin inhibitor, inogatran, for unstable angina or non-Q-wave infarction. METHODS: Thirty-seven patients, treated within 72 h of symptoms, were allocated consecutively to groups to receive a 4 h infusion with one of three doses of inogatran. Thrombin generation and activity were measured with plasma markers at baseline, after the 4 h treatment period and 4 h later. Ischaemia was monitored using continuous vectorcardiography during the 4 h of treatment and during the subsequent 4 h after inogatran infusion had been stopped, to detect any increase in ischaemic events after the period of treatment. In addition, 12 patients received inogatran as an infusion for 72 h. RESULTS: Inogatran was tolerated well. There were no adverse haemodynamic effects or allergic reactions. Minor bleeding events were detected in 37% of the patients. The biochemical and vectorcardiographic findings indicated suppression of thrombin generation after the 4 h treatment period compared with baseline. During the first 4 h after inogatran treatment, thrombin activity and episodes of ischaemia were increased compared with during the treatment period. CONCLUSION: Inogatran was tolerated well and was safe, but its discontinuation was followed by a reactivation of thrombin activity and ischaemia. Whether this reactivation represented a rebound phenomenon, or merely resulted from the discontinuation of an effective therapy, cannot be established from the present study.

Adult↗
PubMed1996

Mortality and morbidity in diabetic and nondiabetic patients during a 2-year period after coronary artery bypass grafting.

OBJECTIVE: To describe mortality and morbidity during a 2-year period after coronary artery bypass grafting (CABG) among diabetic and nondiabetic patients. RESEARCH DESIGN AND METHODS: All the patients in western Sweden in whom CABG was undertaken between June 1988 and June 1991 and in whom concomitant procedures were not performed were registered prospectively. The study was a prospective follow-up. RESULTS: Diabetic patients (n = 268) differed from nondiabetic patients (n = 1,859) in that more women were included, and the patients more frequently had a previous history of myocardial infarction (MI), hypertension, congestive heart failure, intermittent claudication, and obesity. Diabetic patients more frequently required reoperation and had a higher incidence of peri- and postoperative neurological complications. Mortality during the 30 days after CABG was 6.7% in diabetic patients versus 3.0% in nondiabetic patients (P < 0.01). Mortality between day 30 and 2 years was 7.8 and 3.6%, respectively (P < 0.01). During 2 years of follow-up, a history of diabetes appeared to be a significant independent predictor of death. Whereas the development of MI after discharge from the hospital did not significantly differ between the two groups; 6.3% of diabetic patients developed stroke versus 2.5% in nondiabetic patients (P < 0.001). CONCLUSIONS: Diabetic patients have a mortality rate during the 2-year period after CABG that is about twice that of nondiabetic patients during both the early and late phase after the operation.

Age Factors↗
PubMed1996

[Thrombolysis or angioplasty in acute heart infarct?].

PTCA (percutaneous transluminal coronary angioplasty) has proved to be safe and effective treatment for myocardial infarction which, as compared with thrombolytic treatment, yields more complete revascularisation, better coronary blood flow, reduced mortality, lower relapse rates, and shorter treatment times. There are strong indications that in the near future PTCA will also be accorded a prominent place in the treatment of infarction in the Nordic countries. This will entail changes in the structure of myocardial infarction care.

Angioplasty, Balloon, Coronary↗
PubMed1996

The cardiac health profile: content, reliability and validity of a new disease-specific quality of life questionnaire.

BACKGROUND: The Cardiac Health Profile (CHP) is a new questionnaire for assessing health-related quality of life of patients with cardiovascular diseases. It consists of three parts assessed as follows: the degree of angina pectoris (the CCS scale), the quality of life and subjective scoring of psychosocial 'cost-benefit'. Parts II and III of the questionnaire are based on visual analogous scales and consist of 16 and two questions, respectively, covering nine areas. This quality of life questionnaire has been tested for reliability, validity and sensitivity. METHODS: Eighty consecutive patients with angina pectoris, who were waiting for coronary angiography, were enrolled in the study. Four sets of data were deleted since the respondents were not able to fill in the forms correctly. Fifty-one healthy volunteers constituted a control group. RESULTS: Reliability was assessed by a 'test and retest' method. The resulting correlation coefficient was 0.927 (P = 0.0009). Internal consistency was studied by applying Cronbach's alpha. The internal alpha-coefficient was 0.89. Concurrent validity was studied by comparing the outcome in the Nottingham Profile with the CHP. The intercorrelation indicated good concurrent validity (r = 0.753, P = 0.0001). The construct validity was assessed by performing a factor analysis. The sensitivity was assessed in three ways: analysis of kurtosis, comparison of the group of angina pectoris patients with a healthy control group and by comparing CHP results before a standard intervention (coronary artery bypass grafting) and after. The CHP showed in all of these ways a good sensitivity with statistically significant differences between angina patients and the control group (P < 0.0001). A significant improvement in health-related quality of life was also found after coronary artery bypass grafting compared with before (P = 0.02). CONCLUSIONS: The CHP has been found to be reliable, valid and sensitive and the present findings encourage use of the questionnaire in clinical trials for its further development.

Angina Pectoris↗
PubMed1995

Long-term effects of angiopeptin treatment in coronary angioplasty. Reduction of clinical events but not angiographic restenosis. European Angiopeptin Study Group.

BACKGROUND: Angiopeptin is a cyclic octapeptide analogue of somatostatin that has been shown to limit myointimal thickening of arteries in balloon injury models and to restore the vasodilating response to acetylcholine. A randomized, double-blind placebo controlled trial was conducted to assess the effect of angiopeptin in restenosis prevention after percutaneous transluminal coronary angioplasty (PTCA). METHODS AND RESULTS: Patients received a continuous infusion of either placebo or angiopeptin subcutaneously 6 to 24 hours before PTCA and for 4 days after PTCA (3 mg per 24 hours before PTCA followed by 6 mg per 24 hours after PTCA and for the remaining period). A 1.5-mg bolus dose of placebo or angiopeptin was given at PTCA. Aspirin (acetylsalicylic acid, 150 mg/d) was administered throughout the study period. Coronary angiograms obtained before and after PTCA and at 6-month follow-up were subjected to computerized quantification. Clinical follow-up was performed after 12 months. Primary clinical end points were death, myocardial infarction, coronary artery bypass surgery, or repeat PTCA. In total, 553 patients with 742 lesions were randomized. Clinical follow-up was available for all 553 patients. Angiopeptin decreased the clinical events during 12 months of follow-up from 36.4% in the placebo-treated group to 28.4% in the angiopeptin-treated patients (P = .046). Quantitative angiography after PTCA and at follow-up was available in 423 of 455 patients who underwent successful PTCA. The minimal lumen diameter at follow-up was 1.52 +/- 0.64 mm in the angiopeptin-treated group compared with 1.52 +/- 0.64 mm in the placebo-treated patients (P = .96). The late losses were 0.31 +/- 0.59 and 0.30 +/- 0.62 mm (P = .81) and the restenosis rates (> 50% diameter stenosis at follow-up) were 36% and 37% (P = .85) in the angiopeptin- and placebo-treated groups, respectively. CONCLUSIONS: In this study, angiopeptin significantly decreased the incidence of clinical events, principally the rate of revascularization procedures. In contrast, no significant effect was seen on angiographic variables.

Aged↗
PubMed1995

Endoscopic transthoracic sympathicotomy for severe angina.

We evaluated the antianginal effects of endoscopic transthoracic sympathicotomy (ETS) in 24 patients not eligible for coronary bypass surgery or angioplasty. In this procedure, the sympathetic chain is electrocoagulated under general anaesthesia. No major surgical complications occurred. The frequency of anginal attacks was significantly reduced (p = 0.001). The mean increase in maximum exercise capacity was 13 (SD 21) W (p = 0.009). ST depression at maximum comparable workload was reduced by 0.052 (0.10) mV (p = 0.005). Global ejection fraction during exercise and metaiodobenzylguanidine uptake were unchanged. Heart rate variability analysis showed a reduction of the ratio between low and high frequencies at tilt test (-1.00 [0.96]; p < 0.001). We conclude that ETS can be done without major complications, alleviates angina, and increases maximum working capacity in patients with advanced coronary disease.

Aged↗
PubMed1995

Effects of the new calcium antagonist mibefradil (Ro 40-5967) on exercise duration in patients with chronic stable angina pectoris: a multicenter, placebo-controlled study. Ro 40-5967 International Study Group.

Mibefradil (Ro 40-5967) is a novel calcium antagonist from a new chemical class and is the first that selectively blocks the T-type calcium channel. In this multicenter, double-blind, placebo-controlled, parallel designed study, its antianginal and antiischemic effects were evaluated in 126 patients with chronic stable angina pectoris. Exercise tests were performed after 1 week of placebo (baseline) and 2 weeks after randomization to 25, 50, 100, and 150 mg (once daily) or placebo. Highly significant dose-response relations were present across all treatment groups for exercise duration, time to angina, and time to ST-segment depression. They were associated with a dose-dependent decrease in heart rate and blood pressure and plasma concentrations > 300 ng/ml. Mibefradil was well tolerated. First-degree atrioventricular block (8%) and dizziness (7%) were the most frequently reported adverse events; however, the first-degree atrioventricular block was dose-related, and only one patient discontinued the trial because of dizziness. The excellent efficacy and adequate safety profile of mibefradil may be a consequence of T-type calcium-channel selectivity.

Adult↗
PubMed1995

Randomized double-blind Scandinavian trial of angiopeptin versus placebo for the prevention of clinical events and restenosis after coronary balloon angioplasty.

Angiopeptin, a somatostatin analogue, inhibits intimal hyperplasia after percutaneous transluminal coronary artery balloon angioplasty (PTCA) in several animal models. This pilot study sought to determine the effect of subcutaneous infusion of angiopeptin on clinical events and restenosis in patients undergoing successful PTCA. One hundred twelve patients were randomized to receive continuous subcutaneous angiopeptin (750 micrograms/day) or placebo infusion from the day before PTCA and for the following 4 days in a double-blind study. An additional subcutaneous injection of 375 micrograms of angiopeptin or saline was given immediately before PTCA. Eighty patients had a successful PTCA, and 75 of these patients with 94 lesions underwent angiography 6 +/- 2 months after PTCA. All 112 patients underwent a 12-month clinical follow-up examination. Age, sex, smoking, diabetes, hypertension, hyperlipidemia, and morphologic features of stenosis were similar in both groups. The hierarchical 12-month event rate (death, myocardial infarction, coronary artery bypass grafting, and repeated PTCA) was reduced from 34% to 25% (p = 0.30) by angiopeptin by intention-to-treat analysis. Restenosis (> or = 50% diameter stenosis) was significantly reduced in lesions treated with angiopeptin (12% vs 40%; p = 0.003). Late lumen loss also was significantly reduced after angiopeptin treatment (0.12 +/- 0.46 mm vs 0.52 +/- 0.64 mm; p = 0.003). In conclusion, continuous subcutaneous angiopeptin infusion for 5 days tended to decrease clinical events and restenosis after PTCA.

Angioplasty, Balloon, Coronary↗
PubMed1995

Assessment of coronary artery stenosis during PTCA by measurement of the trans-stenotic pressure gradient. Comparison with quantitative coronary angiography.

A fibreoptic pressure sensor mounted on an 0.018 inch guidewire (Pressure Guide, RadiMedical Systems, Uppsala, Sweden) was used to measure the trans-stenotic pressure gradient in 20 patients admitted for percutaneous transluminal coronary angioplasty (PTCA) of a single, discrete stenosis. Pressure measurements were made both at rest and during maximal vasodilatation induced by intracoronary injection of papaverine. From the ratio of distal coronary pressure divided by the proximal pressure, the relative coronary flow reserve was calculated. The aim of the study was to compare the different pressure-derived parameters by correlating them to stenosis geometry estimated by quantitative coronary angiography. There was a moderate correlation between baseline pressure gradient and percent area stenosis; r = 0.64, P < 0.001 and minimal cross-sectional area; r = 0.45, P < 0.005. A higher correlation was found between hyperaemic pressure gradient and area stenosis (r = 0.80, P < 0.001) and minimal cross-sectional areas, respectively (r = 0.55, P < 0.005). The best correlation was found between relative coronary flow reserve and area stenosis (r = 0.86, P < 0.001) and minimal cross-sectional area (r = 0.70, P < 0.001). In conclusion, pressure measurement using a pressure guidewire is useful as a complement to angiography in evaluation of coronary stenoses during PTCA. Pressures should be measured during maximal vasodilatation. Relative coronary flow reserve calculated from the pressure measurements provides additional information about the fraction of normal maximal flow possible in the presence of a stenosis.

Aged↗
PubMed1995

Future challenges to coronary angioplasty: perspectives on intracoronary imaging and physiology.

Several intravascular techniques have been developed with the purpose of achieving optimal guidance for treatment during coronary angioplasty (PTCA). Although the coronary angiographic technique is well established, there are still some inherent limitations. Due to intimal rupture, tears, dissection and thrombus following PTCA treatment, angiography does not allow exact delineation of the true borders of the vessel. Coronary angioscopy is currently the most sensitive method to detect coronary thrombus and can also be used to classify atheromatous plaques. Furthermore, coronary dissection can be detected with more accuracy than with angiography. One limitation associated with angioscopy is the need to occlude the vessel during imaging, which may create myocardial ischaemia. Furthermore, there is presently no method for quantifying angioscopic findings. Intravascular ultrasound produces a cross-sectional image of the vessel, which permits analysis of the layers of the vascular wall. Characterization and classification of various types of plaque can be made because thrombus, lipid, fibrous tissue and calcium have different ultrasonic echogenicity. Flow velocity measurement with the Doppler technique is an interesting approach to the physiological assessment of coronary stenoses. Coronary flow reserve can be estimated with this method and monitoring of the flow signal following angioplasty will aid in the diagnosis of flow-limiting complications. The trans-stenotic pressure gradient is a valuable measure of the haemodynamic importance of a coronary lesion. Trans-stenotic gradients during maximal hyperaemia obtained with a miniaturized pressure transducer yield reliable information regarding the severity of the stenosis, and the pressure values may be used to calculate the relative coronary flow reserve. In conclusion, all of these intracoronary diagnostic techniques will to some extent play a role in the future of coronary angioplasty. Safety, cost and complexity are some of the factors which will determine the growth potential of each method.

Angioplasty, Balloon, Coronary↗