[Treatment of traumatic brain injury in Germany]. / Versorgung Schädel-Hirn-Verletzter in Deutschland.

The relationship between severe, moderate and mild traumatic brain injury (TBI) as well as the course of treatment and quality management, were studied in a 1-year prospective study in regions of Hannover and Münster Germany. A total of 6,783 patients were documented at the initial examination (58.4% male, 28.1% children <16 years old) and 63.5% participated in the follow-up survey 1 year after the accident. Of these TBI patients 5,220 (73%) were admitted to hospital for clinical treatment but only 258 (<4%) received inpatient rehabilitation. The incidence of TBI was 332/100,000 inhabitants and according to the Glasgow Coma Scale (GCS) brain injury was mild in 90.9%, severe in 5.2% and moderate in 3.9%. The main cause of injury was a fall (52.5%) followed by a traffic accident (26.3%). In-hospital mortality was 1%. Only 56% of TBI patients were neurological examined and 63% were examined in hospital within the first hour after the accident. An immediate x-ray of the skull with a doubtful evidential value was made in 82%. Of the participants 35.9% were still receiving medical treatment 1 year after the accident although the majority only suffered mild TBI. An overabundance of severe socioeconomic consequences, e.g. loss of job, accommodation, family, were also found following only mild TBI.

[Federal admission criteria for levels of perinatal care: definition, interpretation and first conclusions]. / Aufnahmekriterien nach dem G-BA-Beschluss: definition, interpretation und erste schlussfolgerungen.

BACKGROUND: The outcome of high risk pregnancies is better in tertiary hospitals. The German government introduced levels of perinatal care only in 2006. The aim of this study was to investigate how many children are to be expected for each level, taking the possible width of interpretation of the admission criteria into account. MATERIALS AND METHODS: Perinatal quality assurance data from four German states (2005) were available. Based on the admission criteria used for level definitions, children were categorised into four different levels of care. To illustrate the possible width of interpretation of these admission criteria three analytical strategies were used. In addition, the distribution of children on different types of hospitals prior to the introduction of levels of care was analysed. RESULTS: Most deliveries (86-93 %) correspond to the lowest level, and only 1-5 % to the highest. Up to 15 % of children who should have been cared for in the highest level were born in hospitals with less than 500 annual deliveries. Among the neonates with risk profiles corresponding to the admission criteria for the two highest levels, up to 30 % were born in delivery units without NICUs. The majority (83 %) of attached NICUs had low caseloads (< 50 neonates < 1500 g / year). CONCLUSION: Most children fulfil the admission criteria for the lowest level of care whereas the need for specialised centres is rather low. Optimising the place of birth appropriately remains a challenge. Definition of levels of care based on admission criteria are difficult to implement due to a broad variety of interpretations.

From registry to quality management: the German Cystic Fibrosis Quality Assessment project 1995 2006.

Since 1995, the German Cystic Fibrosis Quality Assessment project has collected demographic data and outcome parameters. It aims to develop tools for quality management. The basic data of 6,835 patients has been collected annually by 93 centres. Weight for height and body mass index (BMI) indicated nutritional status, and forced expiratory volume in one second (FEV(1)) served as the central respiratory parameter. Data on mortality and survival were calculated. The mean age of all patients has increased from 13.9 yrs in 1995 to 17.7 yrs in 2005, and the percentage of adult patients has increased from 28.4 to 43.4%. Benchmarking diagrams and centre reports indicated considerable differences between the centres. The achievement of basic aims at the age of 6, 12 and 18 yrs indicated a positive development in 1995 to 2005. In 2005, median age at death was 23.7 yrs and the median cumulative survival was 37.4 yrs. Mortality correlated with a BMI <19 kg x m(-2) and an FEV(1) <80%. No sex gap in mortality was detected. "Learning from the best" is now possible. Further improvements in the system of cystic fibrosis care are required, such as: defining alarm signals for early treatment; involvement of patients and their families in quality management; auditing; benchmarking; and in-house training.

[Pregnancies without prenatal care--which women are potentially affected, what are the inherent fetal risks?]. / Schwangerschaften ohne Vorsorgeuntersuchung--welche Frauen sind potenziell betroffen, welche Risiken ergeben sich für das Kind?

BACKGROUND: In the past decades prenatal care has lead to a reduction in maternal and fetal-neonatal morbidity and mortality. However, the number of examinations that should be recommended - especially in low-risk pregnancies - is still unclear. OBJECTIVE: Women not taking part in prenatal care resemble a subgroup of pregnant women at risk. The objective of this study was to define characteristic parameters based on patient's history and clinical outcome and which maternal and fetal-neonatal morbidity has to be taken into account. PATIENTS AND METHODS: From 913 255 data sets of the Perinatal Registry Lower Saxony, Germany, between 1987 and 1999 n = 2 208 pregnancies (0.24 %) were documented as 'not taken part in prenatal care', while n = 163 143 pregnancies were identified as having undergone optimal prenatal care according to the recommendations. Both groups were compared regarding pregnancy associated and obstetrical parameters. Data are given as odds ratio (OR) and 95 % confidence interval (CI) for pregnancies without any prenatal care vs. pregnancies with standard prenatal care. RESULTS: History of still birth: OR 1.750 (1.175 - 2.609), p < 0.05; mother single: 7.271 (6.603 - 8.006), p < 0.01; maternal age < 18 yrs: 9.904 (7.771 - 12.624), p < 0.01; maternal age > 40 yrs: 3.781 (2.900 - 4.907), p < 0.01; German vs. other origin: 0.214 (0.196 - 0.234), p < 0.01; preterm birth: 2.667 (2.380 - 2.989), p < 0.01; cesarean section: 0.728 (0.644 - 0.823), p < 0.05; birth weight < 5 %: 2.552 (2.140 - 2.943), p < 0.01; APGAR at 1 min < 3: 5.463 (4.521 - 6.602), p < 0.01; umbilical artery pH < 7.0: 2.941 (1.753 - 4.932), p < 0.01; neonatal intubation: 3.945 (3.244 - 4.797), p > 0.01; still birth: 6.089 (4.731 - 7.838), p < 0.01; death post partum: 4.444 (3.008 - 6.567), p < 0.01. CONCLUSION: Pregnant women not taking part in prenatal care are younger or older, more frequently foreigners, and present characteristics of a lower socioeconomic status. These pregnancies are associated with a very high potential of neonatal morbidity. From a both medical and economic point of view, it appears to be reasonable to specifically look after those women before or during pregnancy.

[Hospitalization, type of obstetrical clinic and anamnestic risk profile of pregnant women with pregestational diabetes mellitus--results of the perinatal registry of Lower Saxony, Germany]. / Krankenhausaufenthalte, Entbindungskliniken und anamnestisches Risikoprofil präkonzeptioneller Diabetikerinnen--Ergebnisse der Niedersächsischen Perinatalerhebung.

INTRODUCTION: Obstetric and diabetic societies recommend an intensive care of pregnancies in women with pregestational diabetes, an early hospitalization in case of obstetric and internal complications as well as delivery in a perinatal center. OBJECTIVE: To evaluate the number and duration of hospitalization of pregnant women with pregestational diabetes in comparison with non-diabetic women and further more the type of clinics in which both groups were delivered. We also investigated if there were any differences in anamnestic risk factors in correlation with the type of hospital. MATERIAL AND METHODS: The data of the Perinatal Registry of Lower Saxony, Germany, between 1990 and 1999 were analyzed retrospectively. The pregnancies of 2 543 women with pregestational diabetes were compared with the pregnancies of 707 695 non-diabetic women. RESULTS: There was at least one admission to hospital in 40 % of diabetic and 18.6 % of non diabetic women and more than one admission in 11.9 and 3.6 %, respectively (p < 0.001). The number and duration of hospitalization in both groups decreased significantly within the observation period. 57.7 % of all hospitals performed 1 to 4 and 11 % of the hospitals 5 to 9 deliveries of diabetic women per year. In the group of pregnant women with pregestational diabetes 45 % were delivered in clinics with 1 to 4 and 26.4 % in clinics with 5 to 9 deliveries of diabetic women per year. CONCLUSIONS: A higher number and duration of hospitalization was observed in the diabetic group, but both decreased significantly in each group during the observation period. No significant trend for delivering diabetic women in specialized high-risk units could be detected.

[Intrauterine fetal death in pregnancies of women with preconceptional and gestational diabetes mellitus and of women without glucose tolerance disorders. Results of the perinatal registry of Lower Saxony, Germany]. / Intrauteriner Tod des Feten bei präkonzeptionellem Diabetes, Gestationsdiabetes und Schwangerschaften ohne diabetische Stoffwechsellage. Ergebnisse der Perinatalstatistik Niedersachsen.

OBJECT: The prevalence of intrauterine fetal death as well as the relevant risk factors in pregnancies of women with preconceptional and gestational diabetes mellitus and non-diabetic women were investigated. METHODS: The data of the Perinatal Registry of Lower Saxony between 1987 and 1999 for pregnancies of women with preconceptional diabetes mellitus (PDM, n = 3351), gestational diabetes mellitus (GDM, n = 3954) and women without diabetes mellitus (non-diabetic pregnancies, NDM, n = 887,779) were retrospectively analysed. RESULTS: Intrauterine fetal death occurred in 46 women with PDM (1.35 %), 32 women with GDM (0.79 %) and 2756 non-diabetic women (0.31 %). The odds ratio (OR, 95 % CI) for PDM vs. NDM was 4.468 (3.332 - 5.992; p < 0.01) and for GDM vs. NDM it was 2.595 (1.829 - 3.682; p < 0.01). The percentage of death, which occurs before the 32nd week of gestation, was 13 % in pregnancies with PDM, 12.5 % in pregnancies with GDM and 27.7 % in non-diabetic pregnancies. 50 % of fetal deaths in the PDM group, 43.8 % of those in the GDM group and 39.3 % of those in the NDM group occurred after the 36th week of gestation. The percentages of dead fetuses who were under the 10th percentile of growth (small for gestational age, SGA), in pregnancies with PDM, GDM and NDM were 15.2 %, 6.3 %, and 28.7 %, respectively. The percentages of dead fetuses above the 90th percentile of growth (large for gestational age, LGA) were 41.3 % (PDM), 37.5 % (GDM), and 8.7 % (NDM), (p < 0.01 for PDM vs. NDM and for GDM vs. NDM). CONCLUSION: The risk of intrauterine fetal death in pregnancies of diabetic women is still increased. It seems that especially the LGA fetuses of diabetic mothers and SGA fetuses of non-diabetic mothers are at greater risk of intrauterine death.

[Perinatal morbidity in pregnancies of women with preconceptional and gestational diabetes mellitus in comparison with pregnancies of non-diabetic women. Results of the perinatal registry of Lower Saxony, Germany]. / Perinatale Morbidität in Schwangerschaften von präkonzeptionellen Diabetikerinnen und Gestationsdiabetikerinnen im Vergleich mit Nichtdiabetikerinnen. Ergebnisse der Niedersächsischen Perinatalerhebung.

OBJECTIVE: Pregnancies of women with glucose tolerance disorders are still associated with high maternal and perinatal morbidity. In the present population-based study, we investigated the fetal and neonatal risks and complications in pregnancies of women with preconceptional and gestational diabetes in comparison with pregnancies of non-diabetic women. METHODS: A total of 913,255 pregnancies with 926,685 newborns documented by the Perinatal Registry of Lower Saxony, Germany, between 1987 and 1999 was retrospectively evaluated. In particular, the obstetric parameters of 3439 women with preconceptional diabetes mellitus (PDM, n = 3485 neonates), 4051 women with gestational diabetes mellitus (GDM, n = 4155 neonates) and 905,765 non-diabetic women (NDM, n = 919.053 neonates) were analysed. RESULTS: The diabetes groups had a higher rate of preterm birth < 31st week of gestation (PDM vs. NDM odds ratio [OR] 2.341; GDM vs. NDM OR 1.483) and between the 32nd and 37th weeks of gestation (OR 3.688 and 2.418, respectively). The incidences of pathological cardiotocograms (OR 1.519 and 1.258, respectively) and acidosis as indication for operative delivery (OR 5,015 and 2,102, respectively) were increased in the diabetes groups. There was a higher prevalence of birth weight > 4500 g (OR 2.775 and 2.742, respectively) and >95. percentile (OR 4.268 and 3.610, respectively) in newborns of diabetic women. The higher rate of umbilical arterial pH < 7.00 (OR 2.481 and 1.195, respectively) as well as Apgar score at 1 minute <7 (OR 2.971 and 1.897, respectively) indicated a poorer neonatal outcome in pregnancies of women with diabetes mellitus. The frequency of necessary intubation of the infants was significantly higher in the diabetes group (OR 3.384 and 1.317, respectively). There also was an increased prevalence of intrauterine fetal death in pregnancies of diabetic women (OR 4.197 and 2.511, respectively). CONCLUSION: Pregnancies of women with diabetes mellitus are still correlated with higher perinatal risks and complications. The neonatal morbidity in pregnancies with gestational diabetes mellitus was more similar to that of pregnancies with preconceptional diabetes mellitus than to the morbidity in the group of non-diabetic women. Changes of the parameters within the observation period were the same in all three groups and therefore cannot be attributed to a primary more intensive prenatal care of diabetic women.

Quality management in traumatic brain injury (TBI) lessons from the prospective study in 6.800 patients after acute TBI in respect of neurorehabilitation.

Preliminary results on epidemiology, acute hospital care, and neurorehabilitation of TBI are presented of the first ever prospective controlled German study to analyse the use of regional structures and quality management as provided by the German social healthcare system. The sum of inhabitants in Hannover and Münster area was 2,114 million. Within an area of 100 kilometres diameter each. 6.783 acute TBI (58% male) were admitted for acute treatment from March 2000 to 2001. Definition of acute TBI was according to the ICD 10 S-02, S-04, S-06, S-07, S-09 in combination with dizziness or vomiting; retrograde or anterograde amnesia, impaired consciousness, skull fracture, and/or focal neurological impairment. The incidence was 321/100.000 population. Cause of TBI was traffic accident in 26%, during leisure time 35%, at home 30% and at work 15%. Initial GCS (emergency room) was only assessed in 3.731 TBI (=55%). Out of those 3.395 = 90,9% were mild, 145 = 3,9% were moderate, and 191 = 5,2% severe TBI. 28% of 6.783 patients were <1 to 15 years, 18% > 65 years of age. The number admitted to hospital treatment is 5.221 = 77%, of whom 72 patients (=1,4%) died caused by TBI. One year follow-up in 4.307 TBI patients (=63.5%) revealed that only 258 patients (=3,8%) received neurorehabilitation (73% male), but 68% within one month of injury. Five percent of these patients were <16 years of age, 25% > 65 years. Early rehabilitation "B" was performed in 100 patients (=39%), 19% within one week following TBI. The management of frequent complications in 148 patients (=57%) and the high number of one or more different consultations (n = 196) confirmed the author's concept for early neurosurgical rehabilitation in TBI when rehabilitation centres were compared regarding GCS and GOS: Early GOS 1 = 4%; GOS 2 = 2,7%, GOS 3 = 37,3%, GOS 4 = 26,7%, GOS 5 = 29,3%, final GOS scores were 1 = 1,2%, 2 = 1,7%, 3 = 21,8%, 4 = 36,2%, and 5 = 39,1% of all patients at the end of rehabilitation. Mean duration for both "B" and "C" was 41 days compared to 80 days for "D" and "E". An assessment of both GCS and GOS was insufficient.

[Can data from quality assurance programs such as peri-/neonatal compilations be used for secondary epidemiological studies?]. / Können Daten aus Qualitätssicherungsprogrammen wie der Peri-/Neonatalerhebung für sekundärepidemiologische Untersuchungen genutzt werden?

BACKGROUND: The aim of this study was to explore whether population-based data from a regional quality control program can be utilized to compare the neonatal outcome of small for gestational age (SGA) and appropriate size for gestational age (AGA) new-borns. METHODS: The Center for Quality Management in Health Care maintains perinatal data for almost all births in Lower Saxony (Germany). Neonatal data are collected for all infants admitted to hospital within 10 postnatal days. We evaluated linked perinatal and neonatal datasets of 4126 very low birthweight infants (VLBW; < 1500 g), born in 1991 - 1996. After checking for completeness, representativeness, and validity, exclusion criteria were defined to minimize bias and to yield similar proportions of SGA- and AGA-neonates. Since inclusion of all multiple births would lead to an overestimation of maternal risk factors, one sibling was randomly selected from each set of multiples. Bias arising from not well defined study populations should be shown based on univariable mortality analyses (Kaplan-Meier survival curves). RESULTS: Application of exclusion criteria resulted in a final study population of 1623 independent (disjunctive) new-borns from 25 - 29 weeks gestation, 173 of whom were SGA, 1450 AGA. Kaplan-Meier curves from the initial study population and the well defined study base differed significantly. Trend analysis revealed a significant (p < 0.05) increase in proportions of both VLBW (from 0.95 % in 1991 to 1.11 % in 1996; + 17 %) and SGA infants (from 22.7 % to 27.4 %; + 21 %) within the observational period. A well defined data selection process is necessary if data collected for other purposes are to be used for epidemiological studies. Neglecting this labour-intensive work may be one reason for the varying results on the outcome of SGA and AGA infants.

Population based study on the outcome of small for gestational age newborns.

OBJECTIVE: To explore whether and how population based data from a regional quality control programme can be used to investigate the hypothesis that small for gestational age (SGA) very low birthweight infants (VLBW, <1500 g) are at increased risk of death, severe intraventricular haemorrhage (IVH), and periventricular leucomalacia (PVL), but at decreased risk of respiratory distress syndrome (RDS). METHODS: Analyses of population based perinatal/neonatal data (1991-96) from a quality control programme in Lower Saxony, Germany. After assessment of data validity and representativeness, exclusion criteria were defined: birth weight >90th centile, severe malformations, siblings of multiple births, and gestational age (GA) <25 or >29 weeks. Outcomes of interest were death, severe IVH, PVL, and RDS. Multivariable analyses were performed by Cox proportional hazard and logistic regression models. RESULTS: Within the data validation procedure, an increase in proportions of both VLBW (from 0.95% in 1991 to 1.11% in 1996; +17%) and SGA (from 22.7% to 27.4%; +21%) infants became apparent (p<0.05). The study population consisted of 1623 infants (173 SGA). Mortality was 12.1% (n = 196), with an adjusted hazard ratio for SGA infants of 2.54, 95% confidence interval (CI) 1.70 to 3.79. Both groups were at similar risk of severe IVH (adjusted odds ratio 0.93, 95% CI 0.5 to 1.65) and PVL (1.54, 95% CI 0.78 to 2.87), but SGA infants had less RDS (0.57, 95% CI 0.35 to 0.93). Male sex, multiple birth, hypothermia (<35.5 degrees C), and sepsis were associated with IVH and RDS. Infants admitted to hospitals with <36 VLBW admissions/year had increased mortality (adjusted hazard ratio 1.56, 95% CI 1.12 to 2.18). CONCLUSIONS: SGA VLBW infants are at increased risk of death, but not of IVH and PVL, and at decreased risk of RDS. That mortality is higher in smaller hospitals needs further investigation.

Should patients with implantable cardioverter-defibrillators be allowed to drive? Observations in 291 patients from a single center over an 11-year period.

Motor-vehicle driving restrictions for patients with implantable cardioverter-defibrillators (ICDs) vary widely throughout the world because safety concerns have never been adequately resolved in this patient population. To address this issue, we examined the driving behavior of 291 ICD patients to correlate the frequency of device therapy during driving, the occurrence of syncopal symptoms, and the incidence of traffic accidents. Fifty of the 291 patients had never driven. Of the remaining 241 patients, 171 (59%) continued driving postimplant and 70 (24%) elected to stop prior to (n = 30) or at the time of ICD implantation (n = 40). Patients were followed for a mean of 38 +/- 26 months (range < 1-124). During this period, no patients died while driving. Of 11 accidents involving 11 driving patients (6%), only 1 was caused by the driver, and none was related to syncopal symptoms or ICD therapy. Although 2 accidents (8%) occurred within 12 months postimplant, the majority (50%) took place after more than 36 months. ICD therapy was delivered in 8 patients (5%) while driving: 13% (1 episode) of the discharges occurred within the first year postimplant, 13% (1 episode) occurred between 1-2 years, and 74% (6 episodes) occurred > 2 years. None of these patients experienced syncope before or during these episodes. A multivariate analysis was unable to identify any variables that might predict increased risk of ICD therapy (with or without sudden death) while driving and consequent motor vehicle accidents. Our data suggest that such events occur only rarely.

Long-term follow up of patients with implantable cardioverter-defibrillators and mild, moderate, or severe impairment of left ventricular function.

OBJECTIVE: To determine whether patients with life threatening ventricular tachyarrhythmias, impaired left ventricular function, and severe heart failure will benefit from implantable cardioverter-defibrillator (ICD) treatment. DESIGN: 410 patients were followed up after ICD implant. Left ventricular function was assessed by the New York Heart Association (NYHA) functional class of heart failure: 50 patients (12%) were in NYHA I-II, 151 (37%) in NYHA II, 117 (29%) in NYHA II-III, and 92 (22%) in NYHA III. Epicardial ICD implantation was performed in 209 patients (51%) and 201 patients (49%) received non-thoracotomy ICDs. RESULTS: Perioperatively, 12 patients (3%) died, more often after epicardial ICD implant (11/209 patients, 5%) than after transvenous implant (1/201 patients, < 1%) (P < 0.05). During a mean (SD) follow up of 28 (24) months (range < 1 to 114 months), 90 patients (23%) died: nine (2%) died from sudden arrhythmia; five (1%) also died suddenly but probably not from arrhythmic causes; 55 (14%) died from cardiac causes (congestive heart failure, myocardial reinfarction); 21 (5%) died from non-cardiac causes. The three year, five year, and seven year survival was 92-96% for arrhythmic mortality in NYHA class I, II and III, compared to a three year survival of 94% and a five year and seven year survival of 84% for patients in NYHA class II-III. 338 patients (82%) received ICD shocks (21 (SD 43) shocks per patient); patients in NYHA class II (83%), class II-III (84%), and class III (90%) received ICD discharges more often than those in class I-II (64%) (P < 0.05). The mean (SD) time interval between ICD implant and the first ICD shock was shorter in NYHA class II (16 (17) months), class II-III (19 (27) months), and class III (16 (19) months) than in class 0-I (22 (24) months) (P < 0.05). CONCLUSIONS: Patients with mild, moderate, and severe left ventricular dysfunction benefit from ICD treatment and these patients survive for a considerable time after the first shock. Survival is influenced by the degree of left ventricular dysfunction; aggressive treatment of heart failure is necessary as well as ICD therapy.

First experience with a new nonthoracotomy defibrillation lead system.

The clinical efficacy and safety of a new nonthoracotomy defibrillation lead system (TVL lead system, Ventritex, inc., Sunnyvale, Calif.) was studied in patients with ventricular tachycardia or fibrillation. Implantation of the TVL lead system and a Cadence pulse generator (Ventritex, Inc.) was attempted in 27 patients. A subcutaneous patch lead was added if required to achieve adequate defibrillation energy. Patients were monitored for an average of 6 +/- 4 months (range 1 week to 14 months). Implantation was successful in 26 patients (96%). Twenty-three of those patients (88%) were implanted in a lead-alone configuration; the remaining three (12%) required a subcutaneous patch lead. The mean defibrillation threshold was 401 +/- 120 V (12 +/- 7 J) at implantation, 467 +/- 134 V (15 +/- 8 J) at predischarge testing, and 452 +/- 151 V (14 +/- 9 J) at 4-month follow-up. The mean defibrillation threshold at 4 months was not significantly different from that at implant. No deaths, sensing anomalies, infections, lead fractures, or lead dislodgments occurred. One patient required addition of a subcutaneous patch 4 months after device implantation because of an elevated defibrillation threshold. Eight patients (31%) experienced 545 spontaneous arrhythmic episodes, and all episodes were successfully terminated by the device. In conclusion, the TVL lead system combined with Cadence tiered-therapy defibrillator has a high success rate and low complication rate, and it can be recommended for treatment of patients with life-threatening ventricular tachyarrhythmias.

[Cardioverter-defibrillator implantation in the heart catheterization laboratory--observations with 105 patients]. / Kardioverter-Defibrillator-Implantation im Herzkatheterlabor--Beobachtungen bei 105 Patienten.

Today, we are facing an exponential increase in implantation of cardioverter defibrillators (ICD). The intraoperative and follow-up results are reported in 105 patients (pts) with ventricular tachyarrythmias who underwent ICD implantation in the catheterization laboratory. Fifty-seven pts (54%) hat their first ICD implant (G 1), whereas 46 pts (44%) underwent pulse generator replacement or electrode revision (2 pts, 2%) (G 2). In all pts, ICD implant or pulse generator replacement was performed under general anesthesia from the beginning. In 57/58 pts (98%) in G 1, ICD implantation was possible with a mean defibrillation threshold (DFT) of 13 +/- 8 joules. One patient hat a DFT of > 25 joules and ICD implantation was not achieved. This patient underwent epicardial lead implantation 1 day later. One patient in G 1 had a vessel rupture (v. subclavia) intraoperatively. During a mean follow-up of 5 +/- 2 (< 1-13) months, three pts (3%) died from congestive heart failure, 2, 4 and 6 months after device implantation. An infection occurred in 1 patient in G 2, 3 months after generator replacement. Our data show that in the majority of patients ICD implantation in the cath-lab is possible, safe, and the complication rate is low. Therefore, ICD implantation in the cath-lab can generally be recommended.

Implantation and follow-up of a third-generation cardioverter defibrillator: comparison of epicardial and nonthoracotomy defibrillation lead system.

OBJECTIVE: The intraoperative and follow-up results were compared in 67 patients with ventricular tachyarrhythmias who underwent implantation of the Ventritex Cadence defibrillator with either epicardial patch (EPI, 25 patients) or nonthoracotomy CPI Endotak (ENDO, 42 patients) defibrillation lead systems. RESULTS: There was no significant difference between groups in age, sex, structural heart disease, ejection fraction, arrhythmia history, or drug therapy. Successful implantation was accomplished in all patients using either lead system. In the ENDO group, 35 patients (83%) had a defibrillation threshold < or = 550 V and did not require a subcutaneous patch. Intraoperatively, the defibrillation threshold was 453 +/- 139 V (13 +/- 9 J) for EPI and 490 +/- 113 V (15 +/- 8 J) for ENDO (P = NS). There were no perioperative deaths in either group. At predischarge testing, the defibrillation threshold was 445 +/- 183 V (14 +/- 12 J) for EPI and 439 +/- 133 V (13 +/- 7 J) for ENDO (P = NS). During a mean follow-up of 16 +/- 8 months, there were no sudden deaths, and four patients died from congestive heart failure (3 EPI, 1 ENDO). During follow-up, 916 spontaneous arrhythmia episodes occurred in 16 of 25 EPI patients (64%) and 967 episodes occurred in 31 of 42 ENDO patients (74%) (P = NS). The number of episodes detected as ventricular fibrillation were 192 for EPI (21%) and 232 for ENDO (24%), with first shock success in 76% and 75%, respectively; all episodes were successfully terminated by the device. In the remaining episodes detected as ventricular tachycardia, antitachycardia pacing was attempted and was successful in 672 of 724 episodes (93%) with EPI and 666 of 735 episodes (91%) with ENDO lead systems (P = NS). Acceleration of ventricular tachycardia with antitachycardia pacing occurred in 21 episodes (3%) with EPI and in 37 episodes (5%) with ENDO leads (P = NS). CONCLUSIONS: A nonthoracotomy approach using the third generation cardioverter defibrillator Cadence V-100 is safe and effective and has clinical results that are not significantly different from epicardial defibrillation lead systems.

Long-term prognosis of patients with anginalike chest pain and normal coronary angiographic findings.

OBJECTIVES: This study analyzes the long-term course of patients with typical angina pectoris or anginalike chest pain and normal coronary angiographic findings. BACKGROUND: In previous studies of such patients the rate of occurrence of typical coronary events during follow-up has differed widely, depending on the duration of the study and the number of patients. METHODS: One hundred seventy-six patients (mean age 48.3 years) who underwent coronary and left ventricular angiography for typical angina or anginalike chest pain were followed up for 5.8 to 15.8 years (median 12.4). By definition, all patients had normal findings on coronary and left ventricular angiograms; exercise test results were positive in 31. RESULTS: Fourteen patients (8%) had a coronary event (0.65%/year) after an average of 9.3 years (median 9.2). Two of the 14 died of a coronary event (0.09%/year), 1 of cardiogenic shock during acute myocardial infarction, 1 suddenly; 4 had a nonfatal myocardial infarction at an average of 8.1 years (median 9.1); 8 had severe angina pectoris after an average of 10.3 years (median 11.1), confirmed by a second angiogram, now with positive findings. Two patients died of a noncoronary cardiac event (chronic cor pulmonale due to obstructive lung disease, acute pulmonary embolism), eight of a noncardiac cause, mainly cancer. None of the 31 patients with a positive exercise test result had a coronary event. Patients with a coronary event had significantly more risk factors (hypercholesterolemia, hypertension, cigarette smoking, diabetes type II) than did those without an event (average 2.4/patient vs. 1.3/patient, p < 0.01). Chest pain persisted in 133 (81%) of the 164 survivors and disappeared in 31 (19%). CONCLUSIONS: Patients with typical angina or anginalike chest pain and normal coronary angiograms have a good long-term prognosis despite persistence of pain for many years; coronary morbidity and mortality are similar to those of the overall population. An increased risk for the development of coronary events is present mainly in patients with elevated risk factors.

[10 years of therapy with implantable defibrillators--observation in 353 patients]. / 10 Jahre Therapie mit implantierbaren Defibrillatoren--eine Beobachtung bei 353 Patienten.

Since January 1984, the cardioverter-defibrillator (ICD) has been implanted in 353 patients (pts). Epicardial ICD implantation was performed in 207 pts and 146 pts underwent non-thoracotomy ICD implant. Overall operative mortality was 3% (12/353 pts) and was significantly higher in pts with epicardial ICD implantation (11/207 pts, 5%) than in patients who received non-thoracotomy ICDs (1/146 pts, < 1%) (p < 0.05). During a mean follow-up of 25 +/- 23 months, 63 pts (19%) died: 8 pts (0.8% per year) from sudden arrhythmic death and 6 pts (0.8% per year) suddenly without an underlying arrhythmia. Cardiac death was observed in 36 pts (4% per year) and 13 pts (2% per year) died from other causes. Appropriate ICD discharges were observed in 245 pts (72%) with a mean incidence of 22 +/- 44 IC discharges per pt. In pts with third-generation ICDs, 3,542 ventricular tachyarrhythmias (VTA) were observed and terminated by primary ICD shocks in 778 VTA (22%). Antitachycardia pacing was attempted in 2,764 VTA (78%) and was successful in 2,484 VTA (90%).

Cardioverter defibrillator therapy as a bridge to heart transplantation.

The prognosis of patients with severely impaired left ventricular function is poor, with an annual mortality rate of about 50%, and the majority die from sudden cardiac death. Heart transplantation is an accepted therapy for patients with end-stage heart disease; however, about 30% of candidates for transplantation die from sudden cardiac death while on the waiting list. It has been shown that implantable cardioverter defibrillator (ICD) therapy has a low surgical mortality and is highly effective in the prevention of sudden death. Therefore, prophylactic ICD implantation may prevent sudden death in patients with end-stage heart disease while on the waiting list, and it is highly probable that patients with an ICD have a greater chance of survival until a donor heart becomes available. However, this hypothesis still has to be proven by prospective studies.

Cardioverter-defibrillator implantation in the catheterization laboratory: initial experiences in 48 patients.

The exponential increase in cardioverter-defibrillator implantations has resulted in a need for safe implantations that do not require long waiting periods. We report intraoperative and follow-up results in 48 patients with ventricular tachyarrhythmias who underwent cardioverter-defibrillator implantation in the catheterization laboratory. Twenty-six (54%) patients had their first cardioverter-defibrillator implant (group 1), and 22 (46%) patients underwent pulse-generator replacement (group 2). In all patients, cardioverter-defibrillator implant or pulse-generator replacement was performed with the patient under general anesthesia. In 25 (96%) of 26 patients in group 1, cardioverter-defibrillator implantation was possible with a mean defibrillation threshold of 13 +/- 8 J. One patient had a defibrillation threshold of > 25 J, and therefore cardioverter-defibrillator implant was not achieved. This patient underwent epicardial device implantation 1 day later. Another patient in group 1 had vessel rupture (vena subclavia) intraoperatively. During a mean follow-up of 2 +/- 1 months, two patients died from congestive heart failure 2 and 4 months after device implantation. An infection occurred in one patient in group 2, 3 months after generator replacement. In conclusion, these data show that in the majority of patients cardioverter-defibrillator implantation in the catheterization laboratory is safe and has a low complication rate and therefore can generally be recommended.

Infections after cardioverter-defibrillator implantation: observations in 335 patients over 10 years.

OBJECTIVE: To determine the incidence of infection after implantation of a cardioverter-defibrillator and the management of this complication. SUBJECTS: 335 consecutive patients who had a cardioverter-defibrillator implanted between January 1984 and December 1993. MAIN OUTCOME MEASURES: Incidence of infection within the first month after implantation (early infection) and after the first month (late infection). RESULTS: Infections associated with cardioverter-defibrillator devices occurred in 13 patients (3.9%) during a mean follow up of 22 (11) months. All patients had general signs of inflammation, fever (> 37.5 degrees C), and leucocytosis (> 10,000/ml) with or without purulent drainage. Five patients (38%) had infections during the first implantation, whereas eight patients (62%) had infections after replacement of the pulse generator. Early infection was observed in four patients (31%) and late infection in nine (69%). Incidence of infection was higher in patients who underwent epicardial cardioverter-defibrillator implantation (12/207 patients, 5.8%) than in those who received nonthoracotomy lead systems (1/125 patients, 0.8%) (P < 0.05). Infections were caused by staphyloccocus in 10 patients, pseudomonas in two patients, and streptococcus in one patient. The whole device had to be removed in all patients. During a mean follow up of 39 (29) months seven patients died: six of congestive heart failure and one of myocardial reinfarction. CONCLUSIONS: Infection, one of the most serious complications after cardioverter-defibrillator implantation, is associated with increased morbidity and mortality. When infection occurs the system must be removed to avoid a fatal outcome.