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.

Marine n-3 fatty acids, wine intake, and heart rate variability in patients referred for coronary angiography.

BACKGROUND: Dietary n-3 polyunsaturated fatty acids (PUFAs) derived from fish may reduce the incidence of sudden cardiac death (SCD). In addition, wine drinking is suggested to have a protective effect against cardiovascular death. METHODS AND RESULTS: We included 291 patients referred for coronary angiography in whom ischemic heart disease was suspected and all of whom completed a food questionnaire regarding fish and wine intake. The n-3 PUFA composition of granulocyte membranes and of adipose tissue was measured. In addition, 24-hour heart rate variability (HRV) was analyzed. Fish intake was positively associated with the level of n-3 PUFAs in adipose tissue. Significant positive correlation coefficients were found between HRV indices and the levels of n-3 PUFAs in granulocytes. Wine intake was also significantly positively related to HRV, but the patients with the highest wine intake also had the highest intake of fish, as documented by a high n-3 PUFA content in adipose tissue. Multiple linear regression analysis revealed that traditional factors such as treatment with ss-blockers, smoking, age, and previous myocardial infarction were independently related to HRV, and furthermore that n-3 PUFAs (but not wine intake) were significantly independently associated with HRV. CONCLUSIONS: The close positive association between n-3 PUFAs and HRV in patients suspected of having ischemic heart disease may indicate a protective effect of n-3 PUFAs against SCD. This may partly explain the reduction in SCD observed in humans with a modest intake of n-3 PUFA. Wine intake was also positively correlated with HRV, but this correlation was no longer significant after controlling for the cellular level of n-3 PUFA.

Percutaneous transluminal coronary angioplasty versus thrombolysis in acute myocardial infarction.

The aim of this study was to evaluate the outcome of primary percutaneous transluminal coronary angiography (PTCA) in the treatment of acute myocardial infarction (AMI) The study included patients with electrocardiographic signs of transmural AMI, symptom duration of less than 12 h, and with no contraindications to thrombolytic therapy. Patients who had undergone primary PTCA were matched consecutively, for age, gender, infarct localization and duration of symptoms, to patients who had received thrombolytic therapy (82 patients to each group). Patients who were admitted to hospital during daytime had a primary PTCA, whereas those admitted outside daytime were given thrombolytic therapy. In the primary PTCA group, 9 patients had a combined endpoint compared with 22 patients in the thrombolysis group (p < 0.02 ). In-hospital mortality was 3.7% in the PTCA group and 4.9% in the thrombolysis group (ns). At six months, a combined endpoint occurred in 23 patients in the primary PTCA group and in 50 patients in the thrombolysis group (p < 0.00005). Six months' mortality was 4.9% in the PTCA group and 7.3% in the thrombolysis group (ns). Among patients in the PTCA group, left ventricular ejection fraction was significantly higher, stay in hospital was shorter and there were significantly fewer incidences of heart failure and severe arrhythmias than among patients in the thrombolysis group. The results of primary PTCA implemented in our departments are comparable with those reported in randomized trials from experienced centres. Our study indicates that patients treated with primary PTCA have fewer complications, a better left ventricular systolic function and a shorter hospital stay compared with patients treated with thrombolysis.

Arterial thromboembolism in patients with sick sinus syndrome: prediction from pacing mode, atrial fibrillation, and echocardiographic findings.

OBJECTIVE: To evaluate whether thromboembolism in sick sinus syndrome can be predicted by pacing mode, atrial fibrillation, or echocardiographic findings. METHODS: Patients were randomised to single chamber atrial (n = 110) or ventricular (n = 115) pacing. They were divided into subgroups with and without brady-tachy syndrome at time of randomisation. The occurrence of atrial fibrillation and thromboembolism during follow up were investigated and compared with echocardiographic findings. RESULTS: The annual risk of thromboembolism was 5.8% in patients with brady-tachy syndrome randomised to ventricular pacing, 3.2% in patients without brady-tachy syndrome randomised to ventricular pacing, 3% in patients with brady-tachy syndrome randomised to atrial pacing, and 1.5% in patients without brady-tachy syndrome randomised to atrial pacing. In atrial paced patients without brady-tachy syndrome at randomisation and without atrial fibrillation during follow up, the annual risk of thromboembolism was 1.4%. Left atrial size measured by M mode echocardiography was of no value in predicting thromboembolism. CONCLUSIONS: Arterial thromboembolism in patients with sick sinus syndrome is very common and is associated primarily with brady-tachy syndrome at randomisation and with ventricular pacing. The risk of thromboembolism is small in atrial paced patients in whom atrial fibrillation has never been documented.

Atrioventricular conduction during long-term follow-up of patients with sick sinus syndrome.

BACKGROUND: It has been claimed that patients with sick sinus syndrome have an increased risk of developing AV block, but this has never been assessed prospectively. The aim of the present study was to evaluate in a prospective trial AV conduction during the long-term follow-up of patients with sick sinus syndrome. METHODS: Two hundred twenty-five consecutive patients with sick sinus syndrome and intact AV conduction were randomized to undergo single-chamber atrial pacing (110 patients) or single-chamber ventricular pacing (115 patients). Follow-up after 3 months and then yearly included measurement of the PQ interval and, in patients with atrial pacemakers, determination of the atrial stimulus-Q intervals at pacing rates of 100 and 120 bpm. The occurrence of AV block in the atrial group was recorded. During follow-up (mean, 5.5+/-2.4 years), there was no change in PQ interval in either group and no change in atrial stimulus-Q intervals or Wenckebach block point in the atrial group. Four of 110 patients in the atrial group developed grade 2 to 3 AV block that required upgrading of the pacemaker (0.6% per year). Two of these 4 patients had right bundle-branch block at pacemaker implantation. CONCLUSIONS: AV conduction, estimated as PQ interval and atrial stimulus-Q interval at atrial pacing rates of 100 and 120 bpm and the Wenckebach block point, remains stable during long-term follow-up. Thus, treatment with single-chamber atrial pacing is safe and can be recommended to patients with sick sinus syndrome without bundle-branch block.

Heart failure and echocardiographic changes during long-term follow-up of patients with sick sinus syndrome randomized to single-chamber atrial or ventricular pacing.

BACKGROUND: In patients with sick sinus syndrome, choice of pacing mode has been implicated in the development of congestive heart failure. METHODS AND RESULTS: A total of 225 consecutive patients with sick sinus syndrome and intact atrioventricular conduction were randomized to either single-chamber atrial pacing (n = 110) or single-chamber ventricular pacing (n = 115). Clinical assessment included New York Heart Association classification, medication, and M-mode echocardiography before pacemaker implantation, after 3 months, and subsequently once every year. At long-term follow-up (mean, 5.5+/-2.4 years), NYHA class was higher in the ventricular group than in the atrial group (NYHA class I/II/III/IV: 65/44/4/0 versus 84/22/2/1 patients, P=.010). Increase in NYHA class during follow-up was observed in 35 of 113 patients in the ventricular group versus 10 of 109 in the atrial group (P<.0005). Increase in dose of diuretics from randomization to last follow-up was significantly higher in the ventricular group than in the atrial group (21+/-49 versus 8+/-42 mg furosemide/d, P=.033). The left ventricular fractional shortening decreased significantly in the ventricular group (from 0.36+/-0.12 to 0.31+/-0.08, P<.0005) but not in the atrial group (from 0.35+/-0.13 to 0.33+/-0.09, P=.087). The left atrial diameter increased significantly in both treatment groups (ventricular group: from 34+/-7 to 41+/-7 mm, P<.0005; atrial group: from 34+/-6 to 37+/-7 mm, P=.002), but the increase was significantly higher in the ventricular group than in the atrial group (P<.0005). CONCLUSIONS: During long-term follow-up, ventricular pacing is associated with a higher incidence of congestive heart failure and consumption of diuretics than atrial pacing. This is accompanied by a decrease in left ventricular fractional shortening and an increased dilatation of the left atrium in the ventricular paced patients.

Long-term follow-up of patients from a randomised trial of atrial versus ventricular pacing for sick-sinus syndrome.

BACKGROUND: In a previous study of 225 patients with sick-sinus syndrome randomised to either single-chamber atrial pacing (n=110) or single-chamber ventricular pacing (n=115), we found that after a mean follow-up of 3.3 years, atrial pacing was associated with significantly less atrial fibrillation and thromboembolism whereas there was no significant difference in mortality and heart failure between the two groups. We aimed to find out whether this beneficial effect of atrial pacing is maintained during extended follow-up of up to 8 years. METHODS: Follow-up visits for all patients were at 3 months, 12 months, then once a year at which patients had a physical examination, ECG recording, and pacemaker check-up. Endpoints were mortality, cardiovascular death, atrial fibrillation, thromboembolic events, heart failure, and atrioventricular block. Data was analysed on Dec 31, 1996. FINDINGS: At long-term follow-up, 39 patients from the atrial group had died versus 57 from the ventricular group (relative risk 0.66 [95% CI 0.44-0.99]; p=0.045). 19 patients from the atrial group and 39 patients from the ventricular group died from a cardiovascular cause (0.47 [0.27-0.82]; p=0.0065). The cumulative incidences of atrial fibrillation and chronic atrial fibrillation were also significantly lower in the atrial group than in the ventricular group (0.54 [0.33-0.89], p=0.012 and 0.35 [0.16-0.76], p=0.004, respectively). Thromboembolic events occurred in 13 patients in the atrial group and 26 in the ventricular group (0.47 [0.24-0.92], p=0.023). Heart failure was less severe in the atrial group than in the ventricular group (p<0.05). In multivariate analysis, atrial pacing was significantly associated with freedom from thromboembolic events (0.47 [0.24-0.92], p=0.028) and survival from cardiovascular death (0.52 [0.30-0.91], p=0.022), but no longer with overall survival (0.71 [0.46-1.08], p=0.11) or chronic atrial fibrillation (0.45 [0.20-1.05], p=0.063). Atrioventricular block occurred in four patients in the atrial group (0.6% annual risk). INTERPRETATION: The beneficial effect of atrial pacing found in our previous study is enhanced substantially over time. Patients with sick-sinus syndrome should be treated with an atrial rather than ventricular-pacing system because after long-term follow-up, atrial pacing is associated with a significantly higher survival, less atrial fibrillation, fewer thromboembolic complications, less heart failure, and a low-risk of atrioventricular block.

[Sick sinus syndrome. Pacemaker with atrial versus ventricular stimulation]. / Syg sinusknude-syndrom. Pacemakerbehandling med stimulation i atrium versus ventrikel.

In patients with sick sinus syndrome, single chamber atrial pacing has been reported in retrospective studies to be associated with lower frequencies of atrial fibrillation, thromboembolism, heart failure, and mortality than ventricular pacing. We did a prospective randomised trial in 225 consecutive patients (142 women, 83 men; mean age 76 years) with the sick sinus syndrome, randomised to atrial (n = 110) or ventricular (n = 115) pacing and followed for up to five years (mean 40 [SD 18] months). During follow-up, the frequency of atrial fibrillation was higher in the ventricular group. Thromboembolic events (stroke or peripheral arterial embolus) occurred in 20 patients in the ventricular group and in six patients in the atrial group (p = 0.008). Twenty five patients died in the ventricular group compared with 21 in the atrial group (p = 0.74). The number of cases of heart failure did not differ between the two groups. Atrioventricular block occurred in two patients in the atrial group. It is concluded that patients with sick sinus syndrome should be treated with atrial pacing rather than ventricular pacing because atrial pacing is associated with lower frequencies of atrial fibrillation, thromboembolic complications, and a low risk of atrioventricular block.

Prospective randomised trial of atrial versus ventricular pacing in sick-sinus syndrome.

In patients with sick-sinus syndrome, single-chamber atrial pacing has been reported, in retrospective studies, to be associated with lower frequencies of atrial fibrillation, thromboembolism, heart failure, and mortality than ventricular pacing; although single-chamber ventricular pacing is most commonly used. We did a prospective randomised trial in 225 consecutive patients (142 women, 83 men; mean age 76 years) with the sick-sinus syndrome, randomised to atrial (n = 110) or ventricular (n = 115) pacing and followed for up to 5 years (mean 40 [SD 18] months). During follow-up, the frequency of atrial fibrillation was higher in the ventricular group, except at the first follow-up at 3 months. Thromboembolic events (stroke or peripheral arterial embolus) occurred in 20 patients in the ventricular group and in 6 patients in the atrial group (p = 0.0083). 25 patients died in the ventricular group compared with 21 in the atrial group (p = 0.74). Heart failure estimated by the New York Heart Association classification and by the daily doses of diuretics did not differ between the two groups. Atrioventricular block occurred in 2 patients in the atrial group. Patients with sick-sinus syndrome should be treated with atrial pacing rather than ventricular pacing because atrial pacing is associated with lower frequencies of atrial fibrillation, thromboembolic complications, and a low risk of atrioventricular block.

Myopericarditis with cardiac tamponade caused by Neisseria meningitidis serogroup W135.

A case of primary myopericarditis in a previously healthy 19-year-old man is described. The patient presented with chest pain, fever, dyspnoea and arthalgia. Cardiac tamponade developed on the fifth day with recurrence on the seventh day, while meningitis never developed. Blood cultures grew Neisseria meningitidis serogroup W135. The patient was treated with penicillin, pericardiocentesis and prednisone. He recovered without sequelae.

Amaurosis fugax in a Danish community: a prospective study.

A prospective study of amaurosis fugax was carried out in a Danish community (population 481,000); case ascertainment was based on the collaboration of practicing ophthalmologists and general practitioners. Over a 3-year period we registered 131 cases; the annual incidence of "first amaurosis fugax episodes coming to medical attention" was 8.6 and 6.2 per 100,000 population for men and women, respectively. On the basis of a comparison of the age-incidence curves for cerebral and retinal ischemic attacks, the "true" incidence of amaurosis fugax is estimated to be approximately 14/100,000/yr, or 25-30% of the reported incidence of transient ischemic attacks. Clinical and/or radiologic signs of a carotid lesion on the appropriate side were present in 56% of the patients, and an additional 27% had symptoms or signs of other organic cardiovascular disorders. Forty-three (68%) of the 63 patients who underwent arteriography had an atheromatous lesion apparently amenable to carotid endarterectomy. In spite of the case-finding procedures employed in the study, cases of amaurosis fugax suitable for carotid surgery were thus ascertained at a rate of only 3/100,000/yr. This suggests that surgical treatment of patients with retinal ischemic attacks is of minor importance as a preventive measure against stroke in the community.

Anomalous origin of the left coronary artery from the pulmonary artery in an adult.

Anomalous origin of the left coronary artery from the pulmonary artery is a rare, almost universally fatal form of congenital heart disease. A case was diagnosed in a 19 year old woman who had exercise induced syncope and ST segment displacement during exercise stress testing. The anomaly was successfully treated with ligation of the anomalous left coronary artery combined with saphenous vein grafting. Young adults with exercise induced syncope should be examined by exercise stress testing, and if it induces ST segment displacement coronary angiography should be undertaken.

Cardiomyopathy in western Denmark.

A retrospective study was carried out to assess the incidence of cardiomyopathy in western Denmark (Jutland and Funen) (population 2 798 000) during a two year period (1980-81). The WHO/ISCF classification was strictly followed, and rigid criteria for exclusion and inclusion of patients were adopted. Thus cases in which specific heart muscle disorders (myocarditis, alcoholic heart disease, hypertension etc) were merely suspected were excluded. Forty one patients had dilated cardiomyopathy (overall incidence 7.3/10(6) population/year) and 20 hypertrophic cardiomyopathy (overall incidence 3.6/10(6) population/year). In men aged 40-59 years the occurrence of dilated cardiomyopathy was 23.4/10(6) population/year. Only one case of Löffler's endomyocardial disease was diagnosed during the study period. Since the investigation was retrospective and was a study of diseased persons and not a population, and since a specific set of criteria for exclusion and inclusion was rigidly applied, the results represent the minimum frequency of these diseases.

A hemodynamic study of the Carpentier-Edwards and Hancock porcine xenografts in the mitral position.

A hemodynamic study was performed on 11 female and 3 male patients with porcine xenograft (9 Carpentier-Edwards, 5 Hancock) in mitral position on average 32.5 months (range 10-65 months) after the operation. In comparison with the preoperative values, the following parameters showed statistically significant post-operative decrease (mean values): wedge pressure (from 22.9 to 13.7 mmHg), pulmonary artery pressure (33.6-21.7), right atrial pressure (7.1-4.2) and pulmonary vascular resistance (3.6-1.9 mmHg/l/min). In a supine bicycle exercise test the mean wedge pressure rose to 27.8 (range 15-44) mmHg. The transvalvular average diastolic gradient showed a mean value of 6.9 (range 4-12 mmHg). The corresponding figures for the calculated valve area were 2.0 (1.0-3.5) cm2. A biplane left ventriculography showed no valvular or paravalvular regurgitation to the left atrium in any patient. The wedge pressures during exercise were significantly correlated with graft diameters. The results were compared with previous reports on mechanical and biological mitral prostheses, and it was concluded that implantation of a porcine xenograft in the mitral position is a satisfactory procedure in severe mitral disease.