Biomedical subjects

K Seidl

Publications and source records attributed to K Seidl.

At least 37 records · Page 2Linked to original sources

PubMed2001

Worldwide clinical experience with a new dual-chamber implantable cardioverter defibrillator system.

INTRODUCTION: Management of atrial tachyarrhythmias represents a significant challenge in patients with implantable cardioverter defibrillators (ICDs). Drug therapy of these arrhythmias is limited by moderate efficacy, ventricular proarrhythmia, and drug-device interactions. This study tested the safety and efficacy of a new dual-chamber ICD to detect and treat atrial as well as ventricular tachyarrhythmias. METHODS AND RESULTS: A dual-chamber ICD (Medtronic 7250 Jewel AF) was implanted in 293 of 303 patients at 49 centers in Europe, Canada, and North America. Specific data were collected at implant and during a mean follow-up period of 7.9+/-4.7 months. There were no clinically evident failures to detect and treat ventricular arrhythmias. In patients with at least one of the dual-chamber detection criteria activated, 1,056 of 1,192 episodes of ventricular tachycardia or fibrillation detected were judged to be appropriate (89% positive predictive accuracy). Therapy efficacy was 100% in the ventricular fibrillation zone and 98% in the ventricular tachycardia zone. Positive predictive accuracy for detection of atrial episodes was 95% (1,052/1,107). For episodes classified as atrial tachycardia by the device, the efficacy of atrial antitachycardia pacing and high-frequency (50-Hz) burst pacing was 55% and 17%, respectively. High-frequency burst pacing terminated 16.8% of episodes classified as atrial fibrillation, and atrial defibrillation had an estimated efficacy of 76%. The actuarial estimates of 6-month complication-free survival and total survival were 88% and 94%, respectively. CONCLUSION: This novel dual-chamber ICD is capable of safely and effectively discriminating atrial from ventricular tachyarrhythmias and of treating atrial tachyarrhythmias without compromising detection and treatment of ventricular tachyarrhythmias.

Aged↗

PubMed2001

Defibrillation efficacy comparing a subcutaneous array electrode versus an "active can" implantable cardioverter defibrillator and a subcutaneous array electrode in addition to an "active can" implantable cardioverter defibrillator: results from active can versus array trials I and II.

INTRODUCTION: Placement of implantable cardioverter defibrillators (ICDs) has been simplified by using the shell of a pectorally implanted ICD as a defibrillation electrode in combination with an endocardial right ventricular defibrillation lead. However, a sufficiently low defibrillation threshold (DFT) cannot be obtained in a few patients. Therefore, alternative approaches were systematically tested in the Active Can versus Array Trial (ACAT). METHODS AND RESULTS: In the first of two prospective randomized studies, the DFT of a subcutaneous left dorsolateral array anode introduced from a pectoral incision was compared to that of a standard active can anode in 68 patients. Intraoperatively, the DFT was determined twice in each patient using either the active can or, in patients with a subcutaneous array lead, once with all three fingers and once omitting the middle finger of the array. The second prospective randomized study included 40 patients. DFT also was determined twice in each patient using an active can in a left pectoral position as anode alone and combined with a left dorsolateral array electrode with two fingers. In ACAT I, stored energy at DFT decreased from 13.1+/-7.7 J (active can) to 9.6+/-6.1 J (three-finger array lead) (P = 0.04), impedance decreased from 53+/-8 ohms to 40+/-6 ohms (P < 0.0001). Omitting the middle finger of the array lead, stored energy at DFT increased by 0.9 J (P = 0.47) and impedance by 2 ohm (P < 0.0001). In ACAT II, DFT and impedance using an active can device were significantly lower when a two-finger array lead was added that decreased stored energy at DFT from 10.1+/-5.2 J to 6.9+/-3.9 J (P = 0.001) and impedance from 56+/-5 1 to 42+/-5 l (P < 0.0001). CONCLUSION: In combination with a right ventricular defibrillation electrode, a left pectoral subcutaneous array lead improves defibrillation efficacy if used instead of, or in addition to, a left pectoral active can ICD device. Implantation of the array lead can be simplified by using two instead of three fingers, without a significant loss of defibrillation efficacy.

Adult↗

PubMed2001

Impact of prehospital delay on mortality in patients with acute myocardial infarction treated with primary angioplasty and intravenous thrombolysis.

BACKGROUND: In patients with acute myocardial infarction treated with thrombolysis, longer times to treatment are associated with increasingly worse clinical outcome. This relation may be different for treatment with primary angioplasty. METHODS: We analyzed the pooled data of the German acute myocardial infarction registries Maximal Individual Therapy in Acute Myocardial Infarction (MITRA) and Myocardial Infarction Registry (MIR) to determine the influence of prehospital delays on hospital mortality rates. Primary angioplasty was performed in 1063 patients and thrombolysis in 7552 patients. RESULTS: In patients treated with thrombolysis, in-hospital time to treatment was constantly 30 minutes median. In patients treated with primary angioplasty, in-hospital time to treatment increased from 60 minutes median up to 87 minutes median with increasing prehospital delay. Hospital mortality rates slightly decreased with increasing prehospital delays in patients treated with primary angioplasty (P for trend =.02). However, in patients treated with thrombolysis, mortality rate was nonsignificantly increased (P for trend =.11). Logistic regression analysis showed no significant difference in mortality rates between primary angioplasty and thrombolysis for prehospital delays of <3 hours. However, when prehospital delay was >3 hours, thrombolysis was independently associated with a higher mortality rate compared with primary angioplasty. CONCLUSIONS: Compared with thrombolysis, primary angioplasty is independently associated with a lower mortality rate in prehospital delays of >3 hours. The reason for this may be a time-dependent loss of efficacy to achieve reperfusion for thrombolysis but not for primary angioplasty.

Angioplasty, Balloon↗

PubMed2001

Primary angioplasty versus no reperfusion therapy in patients with acute myocardial infarction and a pre-hospital delay of > 12-24 hours: results from the pooled data of the maximal individual therapy in acute myocardial infarction (MITRA) registry and the myocardial infarction registry (MIR).

OBJECTIVE: In patients with acute myocardial infarction (AMI), treatment with thrombolysis is superior to no reperfusion therapy only up to 12 hours after the onset of symptoms. There are no data addressing whether this time limit is also justified for treatment with primary angioplasty. DESIGN: The pooled data of two German ST-segment elevation AMI registries, the Maximal Individual Therapy in Acute Myocardial Infarction (MITRA) study and the Myocardial Infarction Registry (MIR), were analyzed. PATIENTS: Out of 22,749 patients, eight hundred and forty-eight with a pre-hospital delay of > 12 hours and < or = 24 hours were treated with either primary angioplasty (94/848; 11.1%) or no reperfusion therapy (754/848; 88.9%). RESULTS: Patients treated with primary angioplasty were 10 years younger (59 years versus 69 years; p = 0.001), more often male [72.3% versus 59.9%; odds ratio (OR) = 0.57; 95% confidence interval (CI) = 0.36-0.92] and less likely to be diabetics (17% versus 27.2%; OR = 0.55; 95% CI = 0.31-0.97). Hospital mortality was 8.5% in patients treated with primary angioplasty compared to 17.1% in patients with no reperfusion therapy (OR = 0.45; 95% CI = 0.21-0.95; p = 0.033) and the combined endpoint (death, reinfarction or stroke) occurred significantly less often (11.7% versus 20.3%; OR = 0.52; 95% CI =0.27-1; p = 0.045). However, multiple logistic regression showed only a non-significant trend for lower mortality (OR = 0.54; 95% CI =0.20-1.23) and the combined endpoint (OR = 0.65; 95% CI = 0.29-1.31) in patients treated with primary angioplasty. CONCLUSIONS: These data show the possibility of a benefit of primary angioplasty over conservative treatment in patients with pre-hospital delays of > 12 up to 24 hours, although multiple logistic regression analysis failed to find significant differences between treatments. This might be due to inadequate study power or a selection bias. These findings encourage further investigation of this subject.

Age Factors↗

PubMed2000

Heart rate dynamics at the onset of ventricular tachyarrhythmias as retrieved from implantable cardioverter-defibrillators in patients with coronary artery disease.

BACKGROUND: The recent availability of implantable cardioverter-defibrillators (ICDs) that record 1024 R-R intervals preceding a ventricular tachyarrhythmia (VTA) provides a unique opportunity to analyze heart rate variability (HRV) before the onset of VTA. METHODS AND RESULTS: Fifty-eight post-myocardial infarction patients with an implanted ICD for recurrent VTA provided 2 sets of 98 heart rate recordings in sinus rhythm: (1) before a VTA and (2) during control conditions. Three subgroups were considered according to the antiarrhythmic (AA) drug regimen. A state of sympathoexcitation was suggested by the significant reduction in HRV before VTA onset compared with control conditions. beta-Blockers and dl-sotalol enhanced HRV in control recordings; nevertheless, HRV declined before VTA independent of AA drugs. A gradual increase in heart rate and decrease in sinus arrhythmia at VTA onset were specific findings of patients who received dl-sotalol. CONCLUSIONS: The peculiar heart rate dynamics observed before VTA onset are suggestive of a state of sympathoexcitation that is independent of AA drugs.

Adrenergic beta-Antagonists↗

PubMed2000

[Initial experience with an implantable loop recorder in patients with unexplained syncope].

Patients with recurrent syncope undiagnosed after extensive noninvasive and invasive testing pose a diagnostic and therapeutic dilemma. Holter monitoring is non-diagnostic in 90% of cases. Recent developments in loop recorder technology permit longterm ECG monitoring in patients with recurrent unexplained syncope. The implantable loop recorder monitors a single lead electrogram continuously using 2 sensing electrodes on the device shell. The device was implanted in 20 patients (11 male, 9 female) with the history of recurrent syncope. During a mean follow-up of 12+/-6 months after device implantation, 11 patients (55%) experienced syncope (8 pts) or presyncope (3 pts). In the remaining 9 patients, no syncope occurred. In all 11 patients with syncope or presyncope during follow-up, loop recording definitively determined whether an arrhythmia was the cause of symptoms or not. Diagnosis included bradycardia in one patient, tachycardia in two patients, in one patient two rhythm disturbances were revealed: frequent ventricular premature beats with bigemini and atrial flutter. Two patients had a neurocardiogenic syncope. Syncope was nonarrhythmic in 5 patients. An implantable loop recorder is useful for establishing the diagnosis if symptoms are recurrent but too infrequent for conventional monitoring techniques.

Aged↗

PubMed2000

Acute myocardial infarction occurring in versus out of the hospital: patient characteristics and clinical outcome. Maximal Individual TheRapy in Acute Myocardial Infarction (MITRA) Study Group.

OBJECTIVES: We describe the baseline characteristics and clinical course of patients who had an acute myocardial infarction (AMI) during their hospital stay. BACKGROUND: In comparison with patients who had an AMI outside of the hospital (prehospital AMI), the data on patients who had an AMI in the hospital are poorly described. METHODS: Patients with an in-hospital AMI were prospectively registered in the Southwest German Maximal Individual TheRapy in Acute myocardial infarction (MITRA) study and compared with patients with prehospital AMI. RESULTS: Of 5,888 patients with AMI, 403 patients (6.8%) had an in-hospital AMI. These patients were older, more often male and sicker as compared with the patients with a prehospital AMI. They also showed a higher prevalence of concomitant diseases, such as arterial hypertension, diabetes mellitus, renal insufficiency and contraindications for thrombolysis. There was no significant difference regarding the use of reperfusion therapy, either thrombolysis (in-hospital AMI 44.2% vs. prehospital AMI 49.1%; odds ratio [OR] 0.86, 95% confidence interval [CI] 0.70 to 1.05) or primary angioplasty (9.9% vs. 8.2%; OR 1.23, 95% CI 0.88 to 1.73), or a combination of both, between the two groups. The interval from symptom onset to the start of treatment in patients receiving reperfusion therapy was 55 min for patients with an in-hospital AMI versus 180 min for patients with a prehospital AMI (p = 0.001). In-hospital death occurred in 110 (27.3%) of 403 patients with an in-hospital versus 762 (13.9%) of 5,485 patients with a prehospital AMI (OR 2.33, 95% CI 1.85 to 2.94). This was confirmed by logistic regression analysis after adjusting for other confounding variables (OR 1.67, 95% CI 1.23 to 2.24). CONCLUSIONS: In-hospital AMI occurred in 6.8% of patients. Time to intervention was shorter; however, the use of reperfusion therapy for in-hospital AMI was not different from that for prehospital AMI. In particular, primary angioplasty seems to be underused in these patients. This, as well as the selection of patients, may result in the high hospital mortality rate of 27.3%.

Aged↗

PubMed2000

Decreasing hospital mortality between 1994 and 1998 in patients with acute myocardial infarction treated with primary angioplasty but not in patients treated with intravenous thrombolysis. Results from the pooled data of the Maximal Individual Therapy in Acute Myocardial Infarction (MITRA) Registry and the Myocardial Infarction Registry (MIR).

OBJECTIVES: We investigated changes in the clinical outcome of primary angioplasty and thrombolysis for the treatment of acute myocardial infarction (AMI) from 1994 to 1998. BACKGROUND: Primary angioplasty for the treatment of AMI is a sophisticated technical procedure that requires experienced personnel and optimized hospital logistics. Growing experience with primary angioplasty in clinical routine and new adjunctive therapies may have improved the outcome over the years. METHODS: The pooled data of two German AMI registries: the Maximal Individual Therapy in AMI (MITRA) study and the Myocardial Infarction Registry (MIR) were analyzed. RESULTS: Of 10,118 lytic eligible patients with AMI, 1,385 (13.7%) were treated with primary angioplasty, and 8,733 (86.3%) received intravenous thrombolysis. Patients characteristics were quite balanced between the two treatment groups, but there was a higher proportion of patients with a prehospital delay of >6 h in those treated with primary angioplasty. The proportion of an in-hospital delay of more than 90 min significantly decreased in patients treated with primary angioplasty over the years (p for trend = 0.015, multivariate odds ratio [OR] for each year of the observation period = 0.84, 95% confidence interval [CI]: 0.73-0.96) but did not change significantly in patients treated with thrombolysis. Hospital mortality decreased significantly in the primary angioplasty group (p = 0.003 for trend; multivariate OR for each year = 0.73, 95% CI: 0.58-0.93). However, for patients treated with thrombolysis, hospital mortality did not change significantly (p for trend 0.175, multivariate OR for each year: 1.02, 95% CI: 0.94- 1.11). CONCLUSIONS: Compared with thrombolysis the clinical results of primary angioplasty for the treatment of AMI improved from 1994 to 1998. This indicates a beneficial effect of the growing experience and optimized hospital logistics of this technique over the years.

Angioplasty, Balloon, Coronary↗

PubMed2000

Diagnostic assessment of recurrent unexplained syncope with a new subcutaneously implantable loop recorder. Reveal-Investigators.

AIM: Patients with recurrent syncope undiagnosed after extensive non-invasive and invasive testing pose a diagnostic and therapeutic dilemma. Holter monitoring is nondiagnostic in 90% of cases. Recent developments in loop recorder technology permit long-term ECG monitoring in patients with recurrent unexplained syncope. The aim of this study was to report the worldwide experience with a new subcutaneously implantable loop recorder, implanted in 133 patients with unexplained syncope and negative laboratory investigations. METHODS AND RESULTS: The implantable loop recorder monitors continuously a single lead electrogram using two sensing electrodes on the device shell. The device was implanted in 133 patients, 67 male and 66 female with recurrent syncope. During a mean follow-up of 10.8 +/- 4.3 months after device implantation, 83 patients (62%) experienced syncope or pre-syncope. In the remaining 50 patients no diagnosis could be made because either no events occurred, the patients were lost to follow-up, had adverse events, or died prior to diagnosis. In 72 of the 83 patients with syncope during follow-up (87%), loop recording definitively determined whether an arrhythmia was the cause of symptoms or not. Diagnosis included bradycardia in 21 patients, pacemaker dysfunction in one patient, and tachycardia in 10 patients. One patient experienced multiple rhythm disturbances. Syncope was non-arrhythmic in 40 patients. The remaining 11 patients failed to press the activator. Therapy was instituted in all patients, in whom an arrhythmic cause was found. Severe anticipated device related complications occurred in three patients. CONCLUSION: An implantable loop recorder is useful for establishing a diagnosis when symptoms are recurrent but too infrequent for conventional monitoring techniques.

Equipment Design↗

PubMed1999

Primary percutaneous transluminal coronary angioplasty for acute myocardial infarction in patients not included in randomized studies. Maximal Individual Therapy in Acute Myocardial Infarction (MITRA) Study Group.

Patients with acute myocardial infarction included in randomized trials comparing primary percutaneous transluminal coronary angioplasty (pPTCA) with thrombolysis represent a special subgroup of patients with a low event rate. Patients excluded from these trials represent a variety of different subgroups, with different patient characteristics and possibly different clinical event rates. Primary PTCA was performed in 491 consecutive patients with acute myocardial infarction in the prospective multicenter observational Maximal Individual Therapy in Acute Myocardial Infarction trial. They were divided into the following groups: group I, patients fulfilling the inclusion criteria of the randomized trials (284 of 491, 58%); group II, patients not included in these trials (207 of 491, 42%). Of group II the following subgroups were defined: group IIa, patients in cardiogenic shock (20 of 491, 4.1%); group IIb, patients with a left bundle branch block (12 of 491, 2,4%); group IIc, patients with contraindications for thrombolysis (42 of 491, 8.6%); group IId, patients with a nondiagnostic first electrocardiogram (95 of 491, 19.3%); group IIe, patients with a prehospital delay of > 12 hours (72 of 491, 14.7%); group IIf, patients with an unknown prehospital delay (30 of 491, 6.1%). A comparison of groups I and II showed similar baseline characteristics but a higher clinical event rate during hospitalization was seen in group II: combined end point of death, reinfarction, heart failure equal to or greater than NYHA class III, any stroke or postinfarction angina, 26.6% versus 18%; p = 0.022. Hospital deaths were nearly twice as high in these patients, without reaching statistical significance (10.6% vs 6%; p = 0.06). The subgroups of group II showed quite different rates of clinical events. In-hospital death rates were: IIa, 40% (8 of 20); IIb, 8% (1 of 12); IIc, 12% (5 of 42); IId, 5% (5 of 95); IIe, 6% (4 of 72); and IIf, 13% (4 of 30). The incidence of the combined end point was 60% (12 of 20) in IIa, 33% (4 of 12) in IIb, 29% (12 of 42) in IIc, 16% (15 of 95) in IId, 26% (19 of 72) in IIe, and 33% (10 of 30) in IIf. Thus, in clinical practice, about half of the patients treated with pPTCA would not have been included in randomized trials comparing pPTCA with thrombolysis. These patients represent a population at higher risk for in hospital clinical events. However, they do represent very different nonhomogenous subgroups with different clinical event rates.

Aged↗

PubMed1999

Comparison of primary angioplasty with conservative therapy in patients with acute myocardial infarction and contraindications for thrombolytic therapy. Maximal Individual Therapy in Acute Myocardial Infarction (MITRA) Study Group.

The benefit of primary angioplasty in patients with acute myocardial infarction (AMI) and contraindications for thrombolysis compared to a conservative regimen is still unclear. Out of 5,869 patients with AMI registered by the MITRA trial, 337 (5.7%) patients had at least one strong contraindication for thrombolytic therapy. Out of these 337 patients 46 (13.6%) were treated with primary angioplasty and 276 (86.4%) were treated conservatively. Patients treated conservatively were older (70 years vs. 60 years; P=0.001), had a higher rate of a history with chronic heart failure (14.8% vs. 4.4%; P=0.053), a higher heart rate at admission (86 beats/min vs. 74 beats/min; P=0.001), and a higher prevalence of diabetes mellitus (27.1% vs. 12.8%; P=0.056). Patients treated with primary angioplasty received more often aspirin (91.3% vs. 74.6%; P=0.012), beta-blockers (60.9% vs. 46.1%; P = 0.062), angiotensin converting enzyme (ACE) inhibitors (71.7% vs. 44%; P=0.001), and the so-called optimal adjunctive medication (54.4% vs. 32.3%; P=0.004). Hospital mortality was significantly lower in patients who received primary angioplasty (univariate: 2.2% vs. 24.7%; P=0.001; multivariate: OR=0.46; P=0.0230). In patients with AMI and contraindications for thrombolytic therapy, primary angioplasty was associated with a significantly lower mortality compared to conservative treatment. Therefore, hospitals without the facilities to perform primary angioplasty should try to refer such patients to centers with the facilities for such a service, if this is possible in an acceptable time.

Aged↗

PubMed1999

Differences in patients with acute myocardial infarction treated with primary angioplasty or thrombolytic therapy. Maximal Individual Therapy in Acute Myocardial Infarction (MITRA) Study Group.

BACKGROUND: Little is known about the differences in patients with acute myocardial infarction (AMI) treated with primary angioplasty or intravenous thrombolysis in clinical practice. METHODS: In all, 5,906 patients with AMI were registered by the Maximal Individual Therapy in Acute Myocardial Infarction (MITRA) study. Of these, 491 (8.3%) patients were treated with primary angioplasty and 2,817 (47.7%) with intravenous thrombolysis. RESULTS: There were only minor differences in baseline characteristics between the two groups. Prehospital delay time (median) was longer in the angioplasty group than in the thrombolysis group (161 vs. 120, p = 0.001), as was door-to-treatment time (88 vs. 30 min; p = 0.001). Patients treated with primary angioplasty more often had contraindications for thrombolytic therapy (12.9 vs. 6%, p = 0.001) and received beta blockers (65 vs. 58.1%, p = 0.004), heparin (98.2 vs. 91.6%, p = 0.001), angiotensin-converting enzyme (ACE) inhibitors (64.8 vs. 50%, p = 0.001) and "optimal" concomitant medication (56.4 vs. 42.9%, p = 0.001) more often. Univariate analysis showed a significant lower incidence of heart failure (5.3 vs. 16.5%, p = 0.001), postinfarct angina (7.3 vs. 16.4%, p = 0.001), in-hospital death (7.9 vs. 11.7%, p = 0.015) and the combined end point (21.6 vs. 40.3%, p = 0.001) in these patients. Stepwise logistic regression analysis revealed optimal concomitant medication [odds ratio (OR) = 0.94, 95% confidence interval (CI): 0.89-0.98) and the type of revascularization (OR = 0.65, 95% CI: 0.58-0.73) to be associated with a significant reduction in the incidence of the combined end point. Similar results were obtained in all predefined subgroups. CONCLUSIONS: In clinical practice, patients treated with primary angioplasty are more often treated with beta blockers and ACE inhibitors than patients treated with intravenous thrombolysis. Thus, the selection of patients and the type of revascularization contributes to the reduction in mortality, overt heart failure, and postinfarct angina in these patients.

Angioplasty, Balloon, Coronary↗

PubMed1999

[1998 prognosis of left ventricular dysfunction in a maximum care non-university hospital. Analysis of the Ludwigshafen LVD Registry].

BACKGROUND: Prognostic data on heart failure rely on epidemiological studies or large clinical trials. These data are not to transfer easily on everyday practice. OBJECTIVE: To assess the prognosis of left ventricular dysfunction under the therapeutic conditions of the 1990s. SETTING: Nonuniversity tertiary care hospital. PATIENTS AND METHODS: Since January 1995 consecutive and complete registry of all inpatients presenting with a left ventricular dysfunction (EF < 45%). No exclusion criteria. RESULTS: n = 512, mean age 64 years, 77% male, mean NYHA class 2.5, left ventricular EF 31%. ETIOLOGY: 58% coronary heart disease, 28% dilated cardiomyopathy. Medical treatment consisting of 91% ACE inhibitors, ACE inhibitor dosage 52% of the recommended dose, 42% beta-blockers, 70% diuretics, and 63% digitalis. Follow-up completeness 95.5%. One-year mortality 64/489 patients (13.9%). Determinants of mortality: NYHA III/IV, EF < 30%, malignant disease, age > 75 years. CONCLUSION: In spite of the aforementioned medical treatment and a proportion of 14.8% implanted defibrillators in 1998, the one-year mortality of ventricular dysfunction is as high as 13.9%. In everyday practice the prognostic effect of ACE inhibition and beta-blockade is not completely utilized.

Adrenergic beta-Antagonists↗

PubMed1999

[Primary dilatation versus thrombolysis in patients with acute myocardial infarct, not included in randomized studies. Results of the MITRA Study. Maximal Individual Optimized Therapy for Acute Myocardial Infarct].

There have been some prospective randomized studies which compared primary angioplasty with intravenous thrombolysis in patients with an acute myocardial infarction (AMI). However, a substantial number of patients with AMI who would not have been included in those trials are treated with one of these two therapeutic options. To describe the proportions, characteristics, and outcome of these patients treated with primary angioplasty or thrombolysis we analyzed the data of the prospective "Maximal Individual Optimized Therapy for Acute Myocardial Infarction" (MITRA) trial. Out of 3308 patients treated with primary angioplasty or thrombolysis, 737 (22.3%) belonged to one of the following groups, not included in current randomized trials: Left bundle branch block, non-diagnostic first ECG, pre-hospital delay > 12 hours or unknown pre-hospital delay. Primary angioplasty was performed in 158/737 (21.4%) and thrombolysis received 579/737 (78.6%) of the patients. There were only minor differences regarding patients' characteristics and concomitant diseases between the two groups. Patients treated with primary angioplasty were 3 years younger (62 years median versus 65 years median (p < 0.036). They also more often showed overt heart failure at admission compared to patients treated with thrombolysis (primary angioplasty: 3.2% versus thrombolysis: 8.9%, OR = 0.34, 95% CI: 0.13-0.86). In-hospital time to intervention was 1 1/2 hours longer in patients treated with primary angioplasty (156 minutes median versus 47 minutes median, p = 0.001). beta-blockers were more often used with primary angioplasty compared to thrombolysis (70.31% versus 55.9%; OR = 1.87, 95% CI: 1.28-2.72), as well as ACE inhibitors (62% versus 49.9%; OR = 1.64, 95% CI: 1.14-2.35). Hospital mortality (8.2% versus 16.4%; OR = 0.46, 95% CI: 0.25-0.84), as well as a combined endpoint of death, reinfarction, postinfarction angina, advanced heart failure, and stroke (24.1% versus 42.3%, OR = 0.43, 95% CI: 0.29-0.64) were lower in patients treated with primary angioplasty compared to those treated with thrombolysis. Logistic regression analysis showed primary angioplasty to be independently associated with a lower rate of the combined endpoint (OR = 0.73, 95% CI: 0.59-0.91), after adjusting for confounding parameters. All subgroups showed a more favorable outcome in patients treated with primary angioplasty. In clinical practice, patients with AMI, not included in current randomized trials comparing primary angioplasty with thrombolysis, account for 22% of all patients with AMI treated with one of those two therapies. Primary angioplasty seems to be associated with a lower event rate compared to thrombolysis in these patients. This has to be confirmed by a prospective randomized trial.

Aged↗

PubMed1999

[Lead-related complications in 340 patients with an implantable cardiverter/defibrillator].

From February 1991 to May 1998, 340 patients had a cardioverter/defibrillator (ICD) implanted. Mean age was 64 +/- 9 years, 278 male and 62 female. 60% of patients had coronary artery disease and 31% dilatative cardiomyopathy. Ejection fraction was 38 +/- 14%. The indication for an implantable cardioverter/defibrillator was in 57% of patients ventricular tachycardia, in 43% ventricular fibrillation. 298 patients had a single-chamber cardioverter/defibrillator implanted, 42 patients a dual-chamber cardioverter/defibrillator. In 25 patients additional subcutaneous patch or array electrodes and in 2 patients additional epicardial patch electrodes were implanted. Implantation site was in 92 patients abdominal and in 248 pectoral. Over a period of 7 years 34 lead-related complications occurred in 33 patients (9.7%), after a median of 2 months after implantation. Diagnosis was made by routine chest x-ray in about 55% of lead-related complications, by clinical presentation (inadequate therapy, pain) in 24%, and by electrical parameters in 21%. In patients with an abdominal implantation site, lead-related complications occurred in 20%, in contrast to 6% in patients with a pectoral implantation site. Regarding patients with pectoral implantation site, lead-related complications were observed in 12% of patients with a dual-chamber ICD vs 4% with a single-chamber ICD (p = 0.05), due to dislocation of atrial electrodes with dual-chamber ICD. There were no differences in clinical parameters between patients with pectoral vs abdominal and between single vs dual-chamber ICD. There were no deaths due to lead-related complications.

Aged↗

PubMed1999

[Clinical experience with the implantable atrial defibrillator (atrioverter) in patients with atrial fibrillation. Metrix Investigators].

Due to the limited efficacy of drug therapy in atrial fibrillation and the high rate of recurrence, strong efforts were made to find non-pharmacological strategies. For three years now, the implantable atrial defibrillator Metrix from InControl has been available as an alternative therapy. From October 1995 to the present the atrial defibrillator was implanted in 179 patients worldwide. The sensitivity of the system and its algorithms to detect atrial fibrillation is 90%; the specificity to detect sinus rhythm is 100%. In 121 of 179 patients, 748 episodes of spontaneous atrial fibrillation were treated with 2.4 shocks per episode. No proarrhythmic event or stroke was seen. A cardioversion to sinus rhythm could be achieved in 95% of patients; the overall clinical success rate was 88%. In 7% of all patients, early recurrence of atrial fibrillation (ERAF) occurred that could not be converted into stable sinus rhythm after further cardioversions and antiarrhythmic therapy. In 4.1% there were lead-related complications, in 4 patients the device had to be explanted because of ineffective therapy, and in 3 patients the device had to be changed because of loss of telemetry or early depletion of battery. In 8 patients, postoperative complications were seen (infections, pneumothorax and thrombosis of the subclavian vein). Overall, the implantable atrial defibrillator Metrix is an effective and safe alternative in treating atrial fibrillation.

Adult↗

PubMed1999

Daytime and nighttime differences in patterns of performance of primary angioplasty in the treatment of patients with acute myocardial infarction. Maximal Individual Therapy in Acute Myocardial Infarction (MITRA) Study Group.

BACKGROUND: Concern exists regarding the results of primary angioplasty for acute myocardial infarction when the procedure is performed during night hours. METHODS AND RESULTS: Between June 1994 and January 1997, 491 patients with acute myocardial infarction who underwent primary angioplasty procedures were consecutive registered in the Maximal Individual Therapy in Acute Myocardial Infarction (MITRA) study. Three hundred seventy-eight patients (77%) were treated during the day and 113 (23%) at night. Baseline characteristics showed no major differences between the 2 groups. Prehospital delay time was 60 minutes shorter during the night (median value 180 minutes for day, 120 minutes for night, P =.005), and in-hospital time to treatment was 9 minutes longer (median value 85 minutes day, 94 minutes night, P =.037). Patients treated during the night more often received angiotensin-converting enzyme blockers (61.4% day, 76.1% night, P =.004) and the so-called optimal adjunctive therapy (54% day, 64.6% night, P =.045). There were no differences concerning clinical events between the 2 groups. Hospital mortality was 8.7% during the day and 5.3% during the night (univariate analysis P =.238; logistic regression P =.653). CONCLUSIONS: In a clinical setting, primary angioplasty for acute myocardial infarction can be performed safely during the night with a clinically insignificant prolongation of in-hospital time to reperfusion compared with practice during the day.

Aged↗

PubMed1999

Radiofrequency catheter ablation of frequent monomorphic ventricular ectopic activity.

INTRODUCTION: Frequent ventricular ectopic beats can result in severe symptoms and may even be incapacitating in some patients. Although radiofrequency catheter ablation is an effective and safe therapy for drug refractory idiopathic ventricular tachycardia, it has not been widely used in ventricular ectopy. The purpose of this study was: (1) to assess the potential role of catheter ablation in eliminating monomorphic ventricular ectopy in symptomatic patients regarding feasibility and safety and (2) to determine the usefulness of various mapping strategies. METHODS AND RESULTS: Forty-one patients with symptomatic ventricular ectopic activity (right ventricular origin in 23 patients, left ventricular origin in 18 patients) were enrolled. The mean frequency of ventricular ectopic beats was 1512+/-583/hour documented by Holter ECG monitoring. These patients had previously been unable to tolerate or had been unsuccessfully treated with a mean of 3+/-1 antiarrhythmic agents. The site of origin was mapped using earliest endocardial activation times, unipolar electrograms and pace mapping. Radiofrequency ablation was successful in 34 (83 %) of 41 patients. Multivariate logistic regression analysis revealed pace mapping as the only independent predictor for a successful ablation site (P < 0.01). After a follow-up of 3 months, the overall success rate was 71%. The mean frequency of ventricular ectopic beats after successful ablation was 12+/-10 ventricular premature beat/hour. CONCLUSION: Radiofrequency catheter ablation is an effective and safe treatment for frequent symptomatic drug refractory monomorphic ventricular ectopic activity. Pace mapping predicts best successful ablation of ventricular ectopic beats.

Adolescent↗