Quality assessment of pacemaker implantations in Denmark.

AIMS: Quality assessment of therapeutic procedures is essential to insure a cost-effective health care system. Pacemaker implantation is a common procedure with more than 500,000 implantations world-wide per year, but the general complication rate is not well described. We studied procedure related complications for all implantations performed in an entire nation over a 3-year period. METHODS AND RESULTS: A prospective study of complications related to 99% of the 5648 primary pacemaker implantations performed in the 12 Danish pacemaker centres in 1997-1999 was carried out. Overall 76% of the patients received a physiological pacemaker system and 91% received the optimal pacing mode according to international guidelines. Perioperative complications requiring reoperation were: haematoma 0.3%, atrial lead related 1.9%, ventricular lead related 1.7%. Late complications requiring reoperation were: infection 02%, atrial lead related 13%, ventricular lead related 1.2%. The complication rate decreased over the study period, but overall the complication rate was higher than expected and showed considerable variation between centres. CONCLUSIONS: Our results demonstrate that sensitive data such as complications related to pacemaker implantations can be collected on a national basis. We suggest that a reoperation rate higher than 3% for atrial as well as ventricular pacing electrodes in the individual implanting centre should cause the centre to evaluate carefully the procedure as well as the performance of the individual implanter.

In-hospital outcome for diabetic patients with acute myocardial infarction in the thrombolytic era.

A 3-year retrospective study was carried out at the Department of Cardiology, Aalborg Hospital, Denmark. The aim of the study was to investigate the in-hospital mortality and complications resulting from acute myocardial infarction in diabetic patients compared with non-diabetic patients in the thrombolytic era and to investigate the correlation between mortality and blood glucose levels in diabetic patients. All patients admitted to the study suffered acute myocardial infarctions. One hundred and twenty-three patients with diabetes and 856 patients without diabetes were included. Mortality was 13% (110 patients) in non-diabetic patients compared with 28% (34 patients) in diabetic patients (p = 0.00002). Eighty-nine patients with diabetes (72%) experienced heart failure or a worsening of heart failure compared with 424 patients without diabetes (50%), p = 0.00001. Twenty-eight diabetic patients (23%) had high-degree atrioventricular block, compared with only 99 non-diabetic patients (12%), p = 0.001. Atrial fibrillation developed in 35 patients with diabetes (28%) and in only 141 patients without diabetes (16%), p = 0.002. No difference was seen in occurrence of ventricular tachyarrhythmias. Diabetic patients with a fatal outcome had significantly higher blood glucose values at admission compared with diabetic patients who survived (17.1 +/- 8.3 vs 13.5 +/- 6.3 mmol/l; p = 0.034), and during hospitalization (85.7 +/- 26.0% of blood glucose values exceeding 10 mmol/l vs 64.5 +/- 33.1; p = 0.00065). In the thrombolytic era diabetic patients with acute myocardial infarction had a higher mortality and experienced more complications during hospitalization compared with non-diabetic patients, and diabetic patients with a fatal outcome had higher blood glucose levels compared with surviving diabetic patients.

Efficacy and safety of intravenously administered dofetilide in acute termination of atrial fibrillation and flutter: a multicenter, randomized, double-blind, placebo-controlled trial. Danish Dofetilide in Atrial Fibrillation and Flutter Study Group.

BACKGROUND: This study was designed to assess the efficacy and safety of intravenous dofetilide in acute termination of atrial fibrillation (AF) and flutter (AFL). Dofetilide, an investigational class III antiarrhythmic agent, selectively inhibits the rapid component of the delayed rectifier potassium current, thus prolonging the effective refractory period and duration of the action potential. Dofetilide can be administered intravenously and has a rapid onset of electrophysiologic action. METHODS AND RESULTS: Ninety-six patients with AF (n = 79) or AFL (n = 17) with a median arrhythmia duration of 62 days (range 1 to 180) were randomized to placebo (n = 30) or 8 micrograms/kg IV dofetilide (n = 66) over 30 minutes. Conversion was defined as termination of the atrial arrhythmia within 3 hours from the start of infusion. The conversion rate was 30.3% after dofetilide and 3.3% after placebo (P <.006). Conversion rate was higher in AFL than in AF: 64% versus 24% (P =. 012). In nonconverters, there was no statistically significant difference between the change in heart rate among the dofetilide-treated compared with the placebo-treated patients (P =. 42). Torsade de pointes ventricular tachycardia developed in 2 patients (3%). In both patients, drug infusion was discontinued before the event because of prolongation of the QT interval. CONCLUSIONS: Intravenous dofetilide is effective in acute termination of AF and AFL of medium duration, with a particularly high efficacy rate in AFL. A small but serious risk of proarrhythmia must be anticipated.

Increased left ventricular systolic function in insulin dependent diabetic patients with normal albumin excretion.

Alterations in cardiovascular function may be an aetiological factor for the development of microalbuminuria in patients with insulin-dependent diabetes mellitus. We studied cardiac function with echocardiography in relation to the degree of albuminuria in 27 insulin-dependent diabetes mellitus patients and 13 healthy subjects. Patients were grouped according to urinary albumin excretion: <20 microg x min(-1) (normoalbuminuric), and 20 to 200 microg x min(-1) (microalbuminuric). None were or had been treated with cardiovascular drugs. The normoalbuminuric patients had a higher heart rate, mean velocity of circumferential shortening, stroke velocity index (a measure of contractility), and aortic peak velocity than controls. No difference in diastolic function was present. In the microalbuminuric group, the stroke velocity index was comparable to values observed in healthy subjects. The increased systolic performance (heart rate and contractility) may contribute to the renal hyperperfusion and glomerular hyperfiltration observed in insulin-dependent diabetes mellitus patients before the development of micro- and in turn macroalbuminuria. The possible cause effect mechanisms should be further studied, as preventive medical treatment of the hypercontractile heart is possible. In conclusion, cardiac contractility is increased in insulin-dependent diabetes mellitus patients with normoalbuminuria and returns to levels observed in healthy subjects when microalbuminuria develops.

Thrombolytic therapy in diabetic patients with acute myocardial infarction.

OBJECTIVE: To compare the frequency of thrombolytic therapy in diabetic and nondiabetic patients with acute myocardial infarction (MI) and to examine why some diabetic patients do not receive thrombolytic therapy. RESEARCH DESIGN AND METHODS: Retrospective study of all diabetic patients with acute MI admitted to the coronary care unit of Aalborg Hospital within a 3-year period. RESULTS: Only 35% (43 of 123) of patients with diabetes compared with 47% (404 of 856) of patients without diabetes received thrombolytic therapy (P < 0.002). There was no difference in the percentage of patients thrombolyzed among patients admitted to the hospital within 12 h after onset of symptoms. Of diabetic patients who were not thrombolyzed, 60% (48 of 80) arrived at the hospital later than 12 h after onset of symptoms. Among patients who arrived late, 63% (35 of 56) had Q wave infarction and 84% (47 of 56) had symptoms typical of acute MI. Mortality was 29% (16 of 56) in this group. Only one patient did not receive thrombolytic therapy due to diabetic retinopathy. CONCLUSIONS: Significantly fewer diabetic patients received thrombolytic therapy compared with patients without diabetes. The main reason diabetic patients did not receive thrombolytic therapy was late arrival to the hospital.

Left ventricular opacification after intravenous injection of Albunex. The effect of different administration procedures.

A clinical study has been performed to investigate the influence of different administration procedures on the degree of contrast enhancement of the left ventricle. The administration variables assessed included Albunex injection rate, arm position, flushing rate and flushing fluid. Twenty-four healthy male volunteers were included. Compared to an injection rate of 1 ml/sec an injection rate of Albunex of 2 ml/sec caused an earlier appearance of contrast in the right ventricle (1 heart beat), whereas transpulmonary passage was not influenced. Horizontal arm position caused a delay in time to peak intensity of 2 to 3 heart beats in both systole and diastole as compared to elevated arm position. Injection rate of 1 ml/sec compared to 2 ml/sec caused a higher peak intensity and mean area under the curve and a longer mean time to peak intensity and transit time. Differences varied from 6 to 230 grey level units out of mean values of 2500. All the observed differences were small and thus probably of no clinical importance. The present study indicates that improvements in the pressure stability characteristics of the albumin microspheres in Albunex have been achieved. This implies that a simple administration procedure can be used. It is recommended that the contrast agent, after resuspension, is injected through a three-way stop cock cannula, followed by 10 ml of saline for flushing. The cannulas or syringes used should be no smaller than 20 G. The injection rate should be 1-2 ml/sec, depending on the diameter of the cannula. By using this procedure, a reliable transpulmonary passage and left ventricular opacification may be obtained.

Night blood pressure: relation to organ lesions in microalbuminuric type 1 diabetic patients.

Ambulatory blood pressure was measured in 23 microalbuminuric Type 1 diabetic patients without hypertension. Nine patients had a reduction in mean arterial blood (MAP) pressure at night < 10% of their day-time value (non-dippers). The following parameters were measured: glomerular filtration rate (GFR), overnight urinary excretion of albumin (UAE), sodium and potassium, left ventricular dimensions, extracellular volume (ECV), plasma aldosterone, and arginine vasopressin (AVP). Night-time MAP was 11 mmHg lower in patients designated as dippers than in non-dippers. Day-time MAP was similar in dippers (98 +/- 5 mmHg) and non-dippers (99 +/- 8 mmHg, NS). No statistical significant difference was found for UAE in dippers (geometric mean, x/- tolerance factor, microgram min-1) (72 x/- 2.1) vs non-dippers (63 x/- 2.1), for left ventricular mass index (63 +/- 12 vs 59 +/- 10 g m-2), or for GFR (134 +/- 19 vs 148 +/- 22 ml min-1). Aldosterone and AVP were lower in non-dippers (p < 0.05) and a negative correlation in all patients was noticed between ECV and aldosterone (rho = -0.50, p < 0.05). Sodium and potassium excretion and ECV were indistinguishable between the groups. We conclude (1) that impaired reduction of night blood pressure does not seem to be associated with more signs of renal or cardiac lesions and (2) that the lower aldosterone and AVP in non-dippers may counteract volume expansion.

Effects of captopril on ambulatory blood pressure, renal and cardiac function in microalbuminuric type 1 diabetic patients.

OBJECTIVE: To study the effect of Captopril on ambulatory blood pressure, renal and cardiac function and extracellular volume in microalbuminuric Type 1 diabetic patients. DESIGN: Randomized, double blind placebo controlled study of two years duration. SETTING: University clinic. PATIENTS: Twenty-two patients without hypertension. INTERVENTION: Patients received 50 mg Captopril or placebo twice a day. MEASUREMENTS: Ambulatory blood pressure, renal function, extracellular volume, and echocardiographic indices of cardiac function and dimensions were assessed annually. Clinic blood pressure and urinary albumin excretion were measured every 3 months. RESULTS: Twenty-four hour mean arterial blood pressure was unchanged in the Captopril group (mean +/- SD) (baseline 93 +/- 4 and follow up 91 +/- 8 mmHg) and in the placebo group (96 +/- 7 and 97 +/- 10 mmHg, NS). Night/day ratio of blood pressure was unaffected. Glomerular filtration rate was unchanged and renal plasma flow increased in the Captopril (557 +/- 97 and 600 +/- 112 ml min-1) versus the placebo group (574 +/- 85 and 535 ml min-1, p = 0.05). Filtration fraction was reduced in the Captopril versus the placebo group (p < 0.05). Extracellular volume and echocardiographically derived parameters were unaffected. The relative change in day time mean arterial blood pressure in the Captopril group correlated with changes in urinary albumin excretion (Spearmans r = 0.85, p < 0.05) unlike clinic mean arterial blood pressure (r = 0.33, p = 0.35). CONCLUSION: Diurnal rhythm of blood pressure was unaffected by long term administration of Captopril. Renal plasma flow was increased and filtration fraction reduced. A significant association between changes in urinary albumin excretion and blood pressure after Captopril was revealed only by the implementation of ambulatory blood pressure measurements.

Early recognition of autonomic dysfunction in microalbuminuria: significance for cardiovascular mortality in diabetes mellitus?

The appearance of microalbuminuria in diabetic patients predicts development of macroalbuminuria and coronary heart disease. Autonomic dysfunction in ischaemic heart disease is related to an increased incidence of arrhythmic deaths. To assess sympathovagal balance in relation to microalbuminuria we performed 24-h spectral analysis of RR interval oscillations in 37 insulin-dependent diabetic patients. Patients were divided according to urinary albumin excretion as normo-(< 20 micrograms/min) (n = 12), micro-(> 20 and < 200 micrograms/min) (n = 14) and macro-albuminuria (> 200 micrograms/min) (n = 11). None had symptoms or signs of ischaemic heart disease at clinical examination or during stress testing. Fourteen matched healthy subjects served as controls. Overall RR interval variability was calculated as the 24-h standard deviation. The square root of power of the low-frequency (0.04-0.15 Hz) and high-frequency (0.15-0.40 Hz) component were considered indices of the sympathovagal interaction and vagal function, respectively. Patients with micro and macroalbuminuria had, compared to control subjects, significantly reduced 24-h standard deviation, a much smaller day/night difference in mean RR level and a significantly reduced amplitude of the low frequency and high frequency oscillations, which were even more reduced in macroalbuminuria. The differences in vagal function were also present after correction for mean RR level, and differences in physical training level and smoking. Insulin-dependent diabetic patients who develop microalbuminuria have significantly impaired vagal function and abnormal sympathovagal interaction, which is further deranged in macroalbuminuria. This early autonomic dysfunction may later contribute to a increased risk for sudden cardiac death.

[Dobutamine stress echocardiography. Use of dobutamine stress echocardiography in diagnosis and assessment of ischemic heart disease]. / Dobutamin stress-ekkokardiografi. Anvendelse af dobutamin stress-ekkokardiografi til diagnosticering og kvantitering af iskoemisk hjertesygdom.

Dobutamine stress echocardiography (DSE) is a new diagnostic method for evaluation of patients with known or suspected coronary artery disease. We studied 30 consecutive patients referred for evaluation of chest pain. Coronary angiography was carried out in 28 patients. DSE was performed the following day. Readable echocardiographic recordings were obtained in all patients. Blinded wall motion analysis revealed a diagnostic sensitivity of 91% (95% confidence limits: 79-100%) for dobutamine stress echocardiography using coronary angiography as reference. No severe adverse events or arrhythmias occurred. It is concluded that DSE is well tolerated, feasible and has a high sensitivity for detecting coronary artery disease.

Association of 24-h cardiac parasympathetic activity and degree of nephropathy in IDDM patients.

In insulin-dependent diabetic patients, nephropathy is a predictor of mortality and coronary heart disease. Impaired cardiac vagal function is an important factor in the pathophysiology of sudden cardiac death in coronary heart disease. Autonomic neuropathy in diabetes in particular involves vagal function. Bedside tests and 24-h measurements of cardiac parasympathetic activity were compared in 37 insulin-dependent diabetic patients, and the relationship between 24-h vagal activity and degree of nephropathy was investigated. Nephropathy was classified according to urinary albumin excretion as normoalbuminuria, incipient, and overt nephropathy. Mean age (approximately 30 yr) was not different among groups. The 24-h measurements of parasympathetic activity appeared more sensitive than bedside tests, as 33% of patients without cardiac autonomic neuropathy in bedside tests had 24-h vagal activity values below the 95% confidence limits of 14 healthy control subjects. Patients with incipient or overt nephropathy had significantly lower mean values for vagal activity during both wake and sleep time than healthy control subjects. Increasing degree of nephropathy was associated significantly with increasing attenuation of 24-h vagal activity (P less than 0.001). The covariation of degree of neuropathy and nephropathy may suggest common pathogenetic mechanisms. The reduced 24-h vagal activity, even in the early stages of nephropathy, could be an important risk factor for cardiac death in insulin-dependent diabetic patients.

Penicillamine-induced polymyositis with complete heart block.

Complete heart block with severe Adams-Stokes attacks and polymyositis was observed in a 69-year-old man following 6 weeks penicillamine treatment for suspected rheumatoid arthritis. After drug withdrawal the muscle enzymes and the cardiac rhythm gradually normalized, only leaving a right bundle branch block. Although this is the first report to show that severe cardiac damage associated with penicillamine-induced polymyositis is a potentially reversible condition, the severity of the three cases reported so far warrants close observation for cardiac involvement in patients with penicillamine-induced polymyositis.

Diabetes-like alterations in hemostatic parameters after growth hormone administration for one week in normal man.

Excess production of growth hormone (GH) in poorly controlled diabetes is believed to be a causal factor in the development of diabetic angiopathy, the mechanism(s) of which is unknown. The present study was undertaken to determine whether exogenous growth hormone would specifically change some quantities and functional parameters known to often be abnormal in long-standing diabetes and thought to result from the development of vascular lesions in general. The authors studied capillary resistance, factor VIII coagulant antigen (F VIII:Ag), von Willebrand factor (vWf:Ag), fibronectin, fibrinogen, and tissue-type plasminogen activator (t-PA) before, during, and after 1 week's subcutaneous GH administration (6 IU per day divided into two doses). Capillary resistance decreased insignificantly, but returned to higher levels (p less than 0.05) 1 week after withdrawal. F VIII:Ag, vWf:Ag, fibronectin, and fibrinogen all increased significantly during GH treatment. Except for F VIII:Ag, these quantities returned to pre-medication levels 7 days after termination of GH administration. The present results may contribute to the clarification of the role of GH hypersecretion in diabetic microangiopathy and macroangiopathy.

Excessive hypercalcaemia and mixed connective tissue disease.

A 23-year-old female with extreme hypercalcaemia was treated with calcitonin, mitramycin and parathyroidectomy and normocalcaemia was achieved after 4 weeks. Nevertheless, the patient later died of cutaneous necrosis, impaired circulation and multiple organ failure. Serum immunoreactive parathyroid hormone was in the normal range and parathyroid tissue normal. Mixed connective tissue disease was diagnosed on the basis of high titers of antibody to extractable nuclear antigen, moderately elevated levels of antibody to nuclear antigen and only marginal elevation of anti-double standed DNA. The role of Cl. difficile toxin in the blood and an acinic cell tumour is unclear.

Painless myocardial infarction in diabetes mellitus--a myth?

One hundred and ten consecutive diabetic patients with acute myocardial infarction (AMI) were compared to a matched group of non-diabetics with AMI, and the pain experienced during the acute episode by each patient was estimated by counting the number of morphine injections given. No significant difference was found regarding the frequency of painless infarctions, the distribution of injections given during the first three days in the coronary unit, or the need for injections after that time. We conclude that contrary to the common supposition, painless AMI in hospitalised patients is almost as frequent among nondiabetics as among diabetics.