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ABSTRACT: In this review of the BAsel Stent Kosten-Effektivitäts Trial (BASKET) the trials and their impact on coronary stenting practice were examined, basing the clinical questions of each study on the findings of the previous study. Are the new drug-eluting stents (DES) cost-effective compared to standard bare-metal stents (BMS) if used in all patients? No. Are there specific subgroups of patients with a particular benefit? Yes. A "targeted stent use" was proposed for daily practice. What is the long-term safety of DES? Unexpected safety problems were observed. Was this a chance finding? No. However, with improved stenting techniques, newer stents and intensified antiplatelet regimens late problems were minimised as shown in the BASKET-PROspective Validation Examination (BASKET-PROVE). Further stent developments? Wait and see! - Many additional questions were raised and answered or are still under investigation. Obviously, answers were not always simple and needed a closer look and this is discussed. The BASKET trials proceeded not only from one question to the other, but also in size and methodology. From the restricted single-centre "local" BASKET study to multicentre international long-term trials, all prospective, randomized and investigator-driven. Their relevance was acknowledged by publications in major medical journals as well as by their impact on US and European practice guidelines and on DES research. These aspects are summarised in the present review, highlighting lessons learned from each study and commenting on the possibilities and difficulties of performing such clinical research in Switzerland.
Schweizerische medizinische Wochenschrift 01/2011; 141:w13263. · 1.68 Impact Factor
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ABSTRACT: The severity of angina is related to a reduction in global quality of life (QoL), which may be improved by anti-ischaemic treatment. It is not known, however, whether improvements relate only to physical or also to mental and social domains of QoL and whether women benefit in a similar way to men.
To relate improvements in angina severity through anti-ischaemic treatment to physical and mental domains of QoL in elderly men and women and to assess differences in this relation between the sexes.
Angina severity and full assessment of QoL by structured, self-administered and validated questionnaires were measured prospectively at baseline and after 6 months' optimal drug or revascularisation treatment in all 301 patients of the Trial of Invasive versus Medical therapy in Elderly (TIME) patients with chronic angina.
At baseline, angina severity correlated significantly with physical domains of QoL (trend test at least p<0.02) and daily activities (p = 0.05). At similar angina levels, women had significantly lower QoL scores than men. With anti-ischaemic treatment, physical as well as mental and social QoL domains and daily activities improved, together with a relief in angina (trend tests at least p<0.02). This was true for women and men and was more pronounced after revascularisation than with medical treatment.
These findings confirm the relation between angina severity and physical limitation. In addition, they show that anti-ischaemic treatment not only relieves angina and improves physical components of QoL but also improves mental and social domains. This is true for women as well as for men despite the lower overall scores for women.
Heart (British Cardiac Society) 02/2008; 94(11):1413-8. · 4.22 Impact Factor
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ABSTRACT: Compared to thrombolysis, acute percutaneous coronary intervention (PCI) in patients with acute myocardial infarction (AMI) allows both immediate revascularisation and identification of additional relevant stenosis, so that subsequently no further risk stratification should be necessary and hospital stay shortened. Our aim was to evaluate the impact of PCI on outcome and length of hospital stay after MI compared to that in the thrombolysis era.
Retrospective evaluation in a Swiss tertiary referral centre of 105 patients with AMI undergoing emergency PCI, who initially were neither in cardiogenic shock nor transferred to another primary or secondary care hospital for further treatment. Main outcome measurement was length of overall hospital stay. Additional measurements included mortality, left ventricular function, and time point of the last major adverse cardiac event (MACE).
Overall hospitalisation time was 11.1 +/- 6.8 days, thus being only 1.5 days shorter than in the thrombolysis era. Age above 70 or type of infarction did not influence hospitalisation time, but age below 60 years did. In-hospital mortality was 1%. Left-ventricular function was considerably impaired (<35%) in 6 patients. After the sixth hospital day, 97% of MACE had occurred. According to a validated risk score, 92% of patients belonged to a low risk group with a 30-day mortality risk of 1.4% or less and could have been discharged not later than day 6.
Our data suggest that an early discharge strategy, although safe in low risk patients is not followed at the present time. This approach could further reduce costs without jeopardizing outcome.
Swiss medical weekly: official journal of the Swiss Society of Infectious Diseases, the Swiss Society of Internal Medicine, the Swiss Society of Pneumology 07/2007; 137(25-26):363-7. · 1.89 Impact Factor
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C Kaiser,
R Jeger,
S Wyrsch,
L Schoeb,
G M Kuster,
P Buser,
S Osswald,
F Bernet,
W Brett,
L Grize, M Pfisterer
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ABSTRACT: Registry patients are generally older and more sick than patients enrolled in trials questioning the generalizability of trial results. We assessed whether such a selection bias also exists in elderly patients with chronic angina referred for catheterization.
All 119 patients age>or=75 years with Trial of Invasive versus Medical Therapy in the Elderly (TIME) inclusion but no major exclusion criteria referred for catheterization during the TIME trial inclusion period in four TIME centers were registered and followed-up for one year. Registry patients differed from the 188 trial patients in the same hospitals in that they were younger, somewhat more frequently male, with less antianginal drugs and studied more often after acute chest pain at rest but with more comorbidities than study patients. Left ventricular ejection fraction and vessel disease were similar. One year mortality was 11.4% in registry and 9.6% in invasive TIME patients but differences disappeared after adjustment for baseline differences. Symptomatic status after one year was similar too.
In elderly patients with chronic angina, a bias in the selection for invasive management exists which seems different from that reported in younger patient settings. After adjustment for these selection factors, however, one-year outcome was remarkably similar in registry and trial patients.
International Journal of Cardiology 07/2006; 110(1):80-5. · 7.08 Impact Factor
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ABSTRACT: The aim of this study was to define the impact of B-type natriuretic peptide (BNP) levels on the management of elderly patients presenting with acute dyspnoea.
We performed a prospective randomized controlled study in 269 elderly patients at least 70 years of age included in the B-type natriuretic peptide for Acute Shortness of breath Evaluation (BASEL) study. Patients were randomly assigned to a diagnostic strategy with (n = 136, BNP group) or without (n = 133, control group) the use of BNP levels provided by a rapid bedside assay. The time to discharge and the total cost of treatment were the primary end-points.
Amongst elderly patients, baseline characteristics were well matched between both groups. The use of BNP levels significantly reduced the time to discharge (median 9.0 in the BNP group versus 11.0 days in the control group; P = 0.029). Total treatment cost was $5381 (95% CI, 4482-6280) in the BNP group when compared with $7411 (95% CI, 6180-8642; P = 0.009) in the control group. In addition, a significant reduction in 30-day mortality was observed (9% in the BNP group versus 17% in the control group; P = 0.039).
Used in conjunction with other clinical information, rapid measurement of BNP in the emergency department improved the management of elderly patients presenting with acute dyspnoea and thereby reduced the time to discharge and the total treatment cost. In addition, BNP testing seemed to reduce 30-day mortality.
Journal of Internal Medicine 08/2005; 258(1):77-85. · 5.48 Impact Factor
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ABSTRACT: The aim of this prospective study was to assess predictors of long-term outcome in patients with documented or suspected coronary artery disease who survive major non-cardiac surgery. The impact of patients' comorbidities, pre-operative heart rate variability and postoperative increase in cardiac troponin I on all-cause mortality and major cardiac events within 2 years was explored using multivariable logistic regression. Six of 173 patients died within the first month after surgery and were excluded from the study. Thirty-four of 167 patients (20%) died 1-24 months after surgery. Independent predictors of all-cause mortality were history of congestive heart failure (odds ratio 6.4 [95%, confidence interval 1.7-24]), pre-operatively depressed heart rate variability (odds ratio 6.4 [95%, confidence interval 1.9-21]), and age > 70 years (odds ratio 4.5 [95%, confidence interval 1.2-16]). In contrast, postoperative elevation of cardiac troponin I did not independently predict all-cause mortality or major cardiac events.
Anaesthesia 01/2005; 60(1):5-11. · 2.96 Impact Factor
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European journal of nuclear medicine and molecular imaging 09/2003; 30(8):1202. · 4.99 Impact Factor
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European Heart Journal 08/2002; 23(13):993-5. · 10.48 Impact Factor
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ABSTRACT: To test the hypothesis that rationing of medical management mainly based on age exists in our health care system today.
We studied 303 consecutive patients hospitalised for acute coronary syndrome (ACS) and 163 consecutive patients hospitalised with congestive heart failure (CHF). They were divided into two age groups; patients aged less than 75 years and those equal to or older than 75 years.
Our main findings were a significant underuse of stress tests (p < 0.001) and coronary angiography (p < 0.0001) in elderly patients with ACS and a significant underuse of echocardiography (p < 0.0001) in patients with CHF of the same age group. In patients with ACS, there was also a trend towards underuse of statins in elderly patients with hypercholesterolaemia. In addition, we noted that the use of beta-blockers in ACS and of ACE inhibitors in CHF was better than in previous published studies but that many patients were still not treated according to evidence based medicine.
The lower rates of diagnostic tests performed and the lower statin use observed in elderly patients suggest "hidden" rationing of health care in elderly patients.
Swiss medical weekly: official journal of the Swiss Society of Infectious Diseases, the Swiss Society of Internal Medicine, the Swiss Society of Pneumology 12/2001; 131(43-44):630-4. · 1.89 Impact Factor
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ABSTRACT: We examined retrospectively 186 patients with acute coronary syndrome (ACS) and 163 patients with cardiac insufficiency (CHF) regarding secondary prevention in hospital or externally. Of the Inhospital-patients with ACS 99% had antithrombotic medicaments (AT), 73% betablockers and 73% a statin. CHF-patients had ACEH in 69%. Externally 120 patients with known coronary heart disease (CHD) received in 91% AT, 66% betablocker, 30% statins and 111 CHF-patients in 49% ACEH. Compared to other studies medical therapy ameliorated in CHD and CHF either stationary and ambulatory. The reasons for low prescription of statins may be due to short time since positive results occurred and to the expensive costs in the setting of pressure because of high cost in health system.
Praxis 11/2001; 90(41):1759-65.
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ABSTRACT: The ability to identify patients with severe coronary artery disease (CAD) by analysis of perfusion defects is limited. The lung/heart ratio (LHR) and transient ischaemic dilatation (TID) have been used for this purpose in thallium-201 scintigraphy. The value of these parameters in technetium-99m sestamibi single-photon emission tomography (SPET) imaging is controversial. In this study, therefore, we determined TID and LHR in a single-day rest/stress 99mTc-sestamibi SPET perfusion protocol and compared these measurements with perfusion defect size (PDS) and angiographic severity of CAD. Severe CAD was defined as >75% left main coronary stenosis and/or >90% proximal left anterior descending artery stenosis and/or >90% proximal stenosis in the left circumflex and right coronary arteries. LHR was determined from a stress anterior planar image recorded < or =6 min after exercise. TID ratio was derived from automatically calculated left ventricular rest/stress volumes, and PDS was measured based on semi-automated computer software (CEqual). Diagnostic accuracy and predictive values were compared between 22 patients with severe and 98 patients without severe CAD. LHRs showed a higher sensitivity (73%) for the assessment of severe CAD as compared to PDS and TID ratio (41% and 23% respectively, P<0.01), whereas specificity was highest for TID ratio [95%, P<0.01 when compared to PDS (84%) and LHR (82%)]. It is concluded that increased LHR in 99mTc-sestamibi myocardial perfusion imaging seems to yield good diagnostic accuracy in the detection of patients with severe CAD and may be derived from a single-day rest/stress study.
European Journal of Nuclear Medicine 07/2001; 28(7):907-10.
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ABSTRACT: To investigate the incidence of chest pain early after percutaneous coronary interventions and its correlation with ECG changes, cardiac enzymes, clinical and procedural variables and follow-up events, we prospectively studied 199 patients (84% male; mean age, 60.1 +/- 9.4 years) after primary successful percutaneous coronary interventions (21% PTCA; 79% additional stent implantation). During the first 16 hours following the intervention, the occurrence of chest pain was noted, ECGs were recorded and serial measurements of cardiac enzymes were performed. Seventy-six patients (38%) with elevated enzyme levels at time 0 were excluded. A clinical follow-up was obtained at 6 months. Forty patients (32.5%) experienced chest pain; new ECG changes were detected in 3 (2.5%). The mean levels of all enzymes were significantly higher in patients with chest pain 16 hours after the intervention. In patients with chest pain versus those without, CK-MB mass and troponin I levels higher than twice the upper normal limit were seen in 43.6% versus 11.0% (p < 0.0001) and 45.0% versus 17.3% (p < 0.002), respectively. Elevated troponin I (< 0.004) and CK-MB mass (< 0.04) as well as presumed ischemic chest pain (< 0.03) could be identified as risk factors for recurrent chest pain during follow-up. In conclusion, chest pain was common early after percutaneous coronary interventions and correlated with elevated cardiac enzymes, suggesting peri-interventional myocardial necrosis. Elevated levels of CK-MB mass and troponin I, as well as presumed ischemic chest pain, were associated with recurrent chest pain during follow-up.
The Journal of invasive cardiology 04/2001; 13(3):211-6. · 1.84 Impact Factor
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ABSTRACT: Changes of the unipolar right ventricular impedance during the cardiac cycle are related to the changing content of blood (low impedance) and tissue (high impedance) around the tip of the pacing electrode. During myocardial contraction, the impedance continuously increases reaching its maximum in late systole. This impedance increase is thought to correlate with right ventricular contractility, and thus, with the inotropic state of the heart. In the new Inos2 DDDR pacemaker, integrated information from the changing ventricular impedance (VIMP) is used for closed-loop regulation of the rate response. The aim of this study was to analyze the effect of increasing dobutamine challenge on RV contractility and the measured impedance signals. In 12 patients (10 men, 68 +/- 12 years) undergoing implantation of an Inos2 DDDR pacemaker (Biotronik), a right ventricular pigtail catheter was inserted for continuous measurements of RV-dP/dtmax and simultaneous VIMP signals during intrinsic and ventricular paced rhythm. Then, a stress test with a stepwise increase of intravenous dobutamine (5-20 micrograms/kg per min) was performed. To assess the relationship between RV contractility and measured sensor signals, normalized values of dP/dtmax and VIMP were compared by linear regression. There was a strong and highly significant correlation between dP/dtmax and VIMP for ventricular paced (r2 = 0.93) and intrinsic rhythm (r2 = 0.92), although the morphologies of the original impedance curves differed quite substantially between paced and intrinsic rhythm in the same patient. Furthermore, VIMP correlated well with sinus rate (r2 = 0.82), although there were at least four patients with documented chronotropic incompetence. We conclude, that for intrinsic and ventricular paced rhythms sensor signals derived from right ventricular unipolar impedance curves closely correlate with dP/dtmax, and thus, with a surrogate of right ventricular contractility during dobutamine stress testing. Our results suggest that "inotropy-sensing" via measurement of intracardiac impedance is highly accurate and seems to be a promising sensor principle for physiological rate adaptation in a closed-loop pacing system.
Pacing and Clinical Electrophysiology 11/2000; 23(10 Pt 1):1502-8. · 1.35 Impact Factor
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ABSTRACT: Quantification of regional myocardial wall velocities is needed in stress echocardiography for transition from subjective to quantitative assessment. Tissue Doppler allows quantitation of wall velocities, but interpretation is difficult and angle-dependent. Calculating the ratios of velocities with similar angles to the beam may overcome angle dependency. We measured left ventricular wall velocities during stress echocardiography with tissue Doppler. Regional peak systolic and early (E) and late (A) diastolic velocities were constructed in a "bull's-eye" format. Regional stress/rest and E/A ratios were calculated. Bull's-eye map construction demanded only minimal manual interaction, and the maps showed the left ventricular velocity distribution, simplifying wall motion reading markedly. Still, apical velocities appeared lower as a result of Doppler angle-dependency. With velocity ratios, angle-dependency was no longer noted. In stress echocardiography, wall motion abnormalities at rest and contractility changes with dobutamine became readily apparent. Bull's-eye display of quantitative tissue Doppler velocity allows rapid assessment of regional wall motion. Calculating the ratio of regional velocities circumvents the angle-dependency of Doppler. This novel technique has the potential for simplified and automated quantitative analysis in stress echocardiography.
Journal of the American Society of Echocardiography 04/1999; 12(3):196-202. · 3.71 Impact Factor
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ABSTRACT: To evaluate maintenance of proper VDD function, defined as persistence of sinus rhythm with atrial synchronous ventricular pacing, and to define factors predicting failure of the VDD mode in patients with atrioventricular (AV) block and normal sinus function.
Observational study in 86 consecutive patients (mean (SD) age 74 (12) years; 38 women, 48 men) with single lead VDD pacing systems (Intermedics Unity, n = 66, Medtronic Thera VDD, n = 20), implanted for high degree AV block with documented normal sinus node. Pacemaker function was assessed by event counters, telemetric measurements, and Holter recordings. Demographic, radiological, and pacing variables were correlated with loss of proper VDD function.
During a mean (SD) follow up of 10 (10) months (range 1-37), sinus rhythm and atrial triggered ventricular pacing were maintained in 70 of 86 patients (81%). Atrial undersensing was observed in nine patients, lead migration in two, atrial fibrillation in three, and symptomatic sinus bradycardia in two. Univariate predictors of loss of proper VDD function were: low position of the atrial dipole relative to the carina (> or = 6 cm; p < 0.01) during fluoroscopy; and maximum programmable atrial sensitivity of the pacemaker (p = 0.03). In a multivariate analysis, only dipole position remained predictive of outcome (p < 0.02). Not predictive were sex, age, symptoms before pacemaker implantation, cardiothoracic ratio or dilatation of individual heart chambers on chest x ray, side of device implant, and P wave amplitude at implant.
To maintain proper VDD function in the long term, a low anatomical dipole position relative to the carina should be avoided. Electrical guidance of dipole positioning does not seem to influence long term outcome.
Heart (British Cardiac Society) 11/1998; 80(4):390-2. · 4.22 Impact Factor
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M Pfisterer,
J L Cox,
C B Granger,
S J Brener,
C D Naylor,
R M Califf,
F van de Werf,
A L Stebbins, K L Lee,
E J Topol,
P W Armstrong
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ABSTRACT: We assessed the use and effects of acute intravenous and later oral atenolol treatment in a prospectively planned post hoc analysis of the GUSTO-I dataset.
Early intravenous beta blockade is generally recommended after myocardial infarction, especially for patients with tachycardia and/or hypertension and those without heart failure.
Besides one of four thrombolytic strategies, patients without hypotension, bradycardia or signs of heart failure were to receive atenolol 5 mg intravenously as soon as possible, another 5 mg intravenously 10 min later and 50 to 100 mg orally daily during hospitalization. We compared the 30-day mortality of patients given no atenolol (n=10,073), any atenolol (n=30,771), any intravenous atenolol (n=18,200), only oral atenolol (n=12,545) and both intravenous and oral drug (n=16,406), after controlling for baseline differences and for early deaths (before oral atenolol could be given).
Patients given any atenolol had a lower baseline risk than those not given atenolol. Adjusted 30-day mortality was significantly lower in atenolol-treated patients, but patients treated with intravenous and oral atenolol treatment vs. oral treatment alone were more likely to die (odds ratio, 1.3; 95% confidence interval, 1.0 to 1.5; p=0.02). Subgroups had similar rates of stroke, intracranial hemorrhage and reinfarction, but intravenous atenolol use was associated with more heart failure, shock, recurrent ischemia and pacemaker use than oral atenolol use.
Although atenolol appears to improve outcomes after thrombolysis for myocardial infarction, early intravenous atenolol seems of limited value. The best approach for most patients may be to begin oral atenolol once stable.
Journal of the American College of Cardiology 10/1998; 32(3):634-40. · 14.16 Impact Factor
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ABSTRACT: The hypothesis that addition of mental stress to physical exercise would modify the circulation response to stress and improve noninvasive detection of myocardial ischemia was tested in a randomized, crossover radionuclide angiocardiographic study. Compared with physical exercise or mental stress alone, combined stress led to higher heart rates and rate-pressure products in early stress stages, to more pronounced symptoms, and to a better discrimination of subjects with and without coronary artery disease by radionuclide angiography.
The American Journal of Cardiology 08/1998; 82(1):109-13. · 3.37 Impact Factor
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ABSTRACT: A cardiac risk stratification test that can be performed during operation would be expected to give valuable information for the therapeutic management of patients who need urgent noncardiac surgery. This study was designed to evaluate the feasibility and safety of a dobutamine-atropine stress protocol to detect inducible demand ischemia in anesthetized patients.
A standard dobutamine-atropine stress protocol was performed in 80 patients with severe coronary artery disease during fentanyl-isoflurane anesthesia. Biplane transesophageal echocardiography and 12-lead electrocardiography were used to detect induced ischemia. After dobutamine testing, esmolol, nitroglycerin, or both were used to revert ischemia and any hemodynamic changes, as appropriate.
The protocol detected inducible ischemia or achieved the target heart rate in 75 of the 80 (94%) patients. None of the prospectively defined adverse outcomes, such as cardiovascular collapse, severe ventricular arrhythmia, persistent (> or =5 min) ischemia, or hemodynamic instability, occurred in any of the patients. Ischemia was induced and detected in 73 of the 80 (91%) patients.
Dobutamine stress echocardiography is feasible in anesthetized patients with severe coronary artery disease. The lack of serious complications and the high sensitivity to detect inducible ischemia in this patient population provide the basis for further evaluation of the safety and diagnostic value of dobutamine stress echocardiography during general anesthesia in larger studies of patients at risk for coronary artery disease undergoing noncardiac surgery.
Anesthesiology 06/1998; 88(5):1233-9. · 5.36 Impact Factor
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ABSTRACT: This study evaluated the advantages of 'selective' over 'non-selective' antiarrhythmic prevention of atrial fibrillation after coronary surgery based on a new risk prediction algorithm.
In a retrospective analysis of a prospective randomized trial, a model for risk prediction was determined based on clinical data of the control group (A; n = 107) and tested in a test group (B; n = 107, treated with low dose sotalol). Using this algorithm, the effect of a 'selective' antiarrhythmic approach in high-risk patients was compared to a 'non-selective' approach, where all patients were treated. In total, 75 (35%) patients developed atrial fibrillation and 14 (7%) side-effects led to discontinuation of study medication. Based on the risk prediction algorithm, 36% of group A patients were classified as high-risk patients with an incidence of atrial fibrillation of 76% compared to 26% in low-risk patients (P < 0.0001). The selective approach, i.e. treatment of high-risk patients only reduced the incidence of atrial fibrillation from 76% to 50% (P = 0.0295) compared to a reduction from 44% to 26% (P = 0.0065) when all patients were treated. More importantly, with the non-selective approach 100% of patients were exposed to the possible side-effects of sotalol and costs compared to 24% only with the selective approach (P < 0.0001).
Thus, a selective approach based on a clinical risk prediction algorithm should improve the cost-effectiveness and safety of low-dose sotalol in the prevention of atrial fibrillation after coronary bypass surgery.
European Heart Journal 05/1998; 19(5):794-800. · 10.48 Impact Factor
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ABSTRACT: Myocardial infarction (MI) in young adults is a rare event. In the Framingham study, the 10-year incidence rate of MI per 1,000 was 12.9 in men 30-34 years old. Overall, 4-8% of patients with acute MI are < or = 40 years old.
It was the purpose of this study to assess the in-hospital and long-term morbidity and mortality in patients < or = 40 years old with acute myocardial infarction compared with older patients in the thrombolytic era.
A consecutive series of 75 patients aged < or = 40 years (mean 35.0 +/- 4.8) with acute myocardial infarction was compared with an equally sized group of patients aged > 40 years (mean 65.1 +/- 9.8).
Thrombolysis or direct percutaneous transluminal coronary angioplasty was performed in 52 versus 24% (p = 0.0004) and 5.3 versus 2.7% (p = NS) in younger and older patients, respectively. Significantly fewer young patients had multivessel disease (28 vs. 64%, p < 0.004). No in-hospital mortality was observed in patients with reperfusion therapy irrespective of age. After a mean followup time of 47 +/- 35 months, cardiac mortality was 0 and 11% (p < 0.03), respectively, in young and older patients with, and 3 versus 24% (p < 0.02) without reperfusion therapy, respectively. In addition, significantly fewer patients in the younger age group developed recurrent angina pectoris (12 vs. 39%, p = 0.0004) or congestive heart failure (9 vs. 34%, p = 0.0005) irrespective of reperfusion therapy.
Our observations demonstrate that long-term prognosis after myocardial infarction in young patients is excellent in the thrombolytic era.
Clinical Cardiology 12/1997; 20(12):993-8. · 2.15 Impact Factor