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PubMed1997

Risk status at discharge and cause of death for postneonatal infant deaths: a total population study.

OBJECTIVES: To obtain population-based, clinical information regarding potentially modifiable factors contributing to death during the postneonatal period (28 to 364 days), we examined all postneonatal infant deaths in four areas of the United States to determine: (1) the cause of death from clinical and autopsy data rather than vital statistics, (2) whether death occurred during initial hospitalization or after discharge, and (3) the portion of postneonatal mortality attributable to infants who left the hospital with identified high-risk medical conditions. DESIGN AND SETTING: Retrospective medical record review of all postneonatal infant deaths with birth weights greater than 500 g (total N = 386) born to mothers residing in: (1) the city of Boston (1984 and 1985, N = 55), (2) the city of St Louis and contiguous areas (1985 and 1986, N = 123), (3) San Diego County (1985, N = 112), and (4) the state of Maine (1984 and 1985, N = 96). Deaths were identified using linked birth and death vital statistics, and medical record audits of infants' and mothers' charts were performed. Causes of death were obtained from medical record review in conjunction with autopsy if performed (72%, N = 278), medical record alone (17%, N = 67), or vital statistics if no other source was available (11%, N = 41). The medical conditions at the time of discharge for each infant were reviewed and, if judged to confer an increased risk of morbidity or mortality, were classified as high risk. RESULTS: The causes of death were sudden infant death syndrome (47%, N = 181), congenital conditions (20%, N = 77), prematurity-related conditions (11%, N = 43), infections (9%, N = 34), external causes (including injuries, drownings, ingestions, and burns) (7%, N = 25), and other (6%, N = 23). In 24% of congenital and 25% to 44% of prematurity-related deaths, infection was the acute or associated cause of death. Infants born to black mothers were more likely than those born to white mothers to die during the postneonatal period of all major causes of death (7.3 per 1000 vs 3.0 per 1000). Overall, 18% (N = 68) of deaths occurred to infants who never left the hospital; 79% (N = 305) of the infants were discharged before death; and discharge status was unknown in 3% (N = 13). Eighty-one percent of all infants with prematurity-related postneonatal deaths were never discharged, and of the total infants who were initially discharged, only 1% (N = 4) subsequently died of prematurity-related causes. Of all postneonatal deaths, only 16% (N = 62) left the hospital with identified high-risk medical conditions. CONCLUSIONS: These findings suggest that the etiology of postneonatal mortality is heterogeneous, with significant complexity in attributing specific causes of death and making designations of "preventability." The vast majority of infants who died of prematurity-related postneonatal causes never left the hospital, and only a small percentage of all infants that left the hospital before death were identified as being at high medical risk. Therefore, strategies for further decreasing postneonatal mortality must link high-risk follow-up programs to more comprehensive strategies that address risk throughout pregnancy and early childhood.

Cause of Death↗
PubMed2000

Sudden death in patients and relatives with the syndrome of right bundle branch block, ST segment elevation in the precordial leads V(1)to V(3)and sudden death.

BACKGROUND: The syndrome with an electrocardiographic pattern of right bundle branch block, ST segment elevation in leads V(1)to V(3)and sudden death is genetically determined and caused by mutations in the cardiac sodium channel. The inheritance of the disease is autosomal dominant. Sudden death may, however, occur from a variety of causes in relatives and patients with this syndrome. PATIENTS AND METHODS: Twenty-five Flemish families with this syndrome with a total of 334 members were studied. Affected members were recognized by means of a typical electrocardiogram either occurring spontaneously or after the intravenous administration of antiarrhythmic drugs. Sudden deaths in these families were classified as related or not to the syndrome by analysis of the data at the time of the event, mode of inheritance of the disease, and data provided by survivors. Results Of the 25 families with the syndrome, 18 were symptomatic (at least one sudden death related to the syndrome) and seven were asymptomatic (no sudden deaths related to the syndrome). In total, there were 42 sudden cardiac deaths (12% incidence). Twenty-four sudden deaths were related to the syndrome and all occurred in symptomatic families. Eighteen sudden deaths (43% of total sudden deaths) were not related to the syndrome (nine cases) or were of unclear cause (nine cases). Three of them occurred in two asymptomatic families and the remaining 15 in five symptomatic families. Twenty-four of the 50 affected members (47%) suffered (aborted) sudden death and 18 of the 284 unaffected members (6%). This difference in the incidence of sudden death was statistically significant (P<0.0001). Patients with (aborted) sudden death caused by the syndrome were younger than patients with sudden death of other or unclear causes (38+/-4 years vs 59+/-3 years respectively, P=0.0003). CONCLUSIONS: In families at high risk of sudden death because of genetically determined diseases, the main cause of sudden death remains the disease. However, almost the half of sudden deaths are caused by unrelated diseases or are of unclear cause. Accurate classification of the causes of sudden death is mandatory for appropriate analysis of the causes of death when designing preventive treatments.

Adolescent↗
PubMed2004

Deaths from complications of unsafe abortion: misclassified second trimester deaths.

This study measured the contribution of abortion-related deaths to overall maternal mortality and calculated the underestimation of maternal mortality using verbal autopsy and clinical record review where available. We reviewed 807 death certificates of women aged 12-50 who died in 2001 in two sites of about 1.5 million inhabitants each in the state of Morelos (primarily rural) and the municipality of Nezahualcóyotl (primarily urban) in the state of Mexico. Deaths were classified as definite, possible or non-maternal deaths. Finally we identified abortion-related deaths and calculated the underestimation of maternal mortality. Among 326 possible maternal deaths, we encountered five misclassified cases: one spontaneous abortion and four non-abortion maternal deaths. Among 32 registered maternal deaths, we found four misclassified cases that were actually second trimester, abortion-related deaths. There were no officially registered abortion-related deaths in either Morelos or Nezahualcóyotl, making the overall underestimation of abortion mortality 100%. Abortion contributed 13.5% of all maternal deaths. The overall underestimation of maternal mortality was 13.55%, higher in Morelos (21.7%). There were no unregistered maternal deaths in Nezahualcóyotl. Unsafe abortion continues to be an important cause of maternal mortality, though first trimester deaths appear to be decreasing. We identified domestic violence as an important cause of death among pregnant and post-partum women, and two abortion-related suicides, and believe these should be reconsidered as indirect maternal deaths. The misclassification of second trimester abortion deaths as maternal deaths from other causes is an obstacle to preventing them.

Abortion, Induced↗
PubMed2003

Cause of death in patients with end-stage renal disease: assessing concordance of death certificates with registry reports.

OBJECTIVES: To assess concordance in reporting, in two Australian national datasets, of cause of death of patients with end-stage renal disease (ESRD). METHODS: For deaths in 1997-99, we compared 'cause of death' and 'primary renal disease', as coded in the Australian and New Zealand Dialysis and Transplant Registry (ANZDATA), with 'underlying' and 'associated' causes of death (based on death certificates), as coded by the Australian Bureau of Statistics (ABS). Dates of birth and death and sex identified the same individuals in the two datasets. Deaths from the three States for which date of birth was not available from death certificates were excluded. Cause of death was compared at the ICD-10 chapter level. RESULTS: Of 1,728 ANZDATA patients from NSW, SA, WA, NT and ACT who died during 1997-99, 1,117 (65%) could be matched to a record in the ABS dataset for the corresponding jurisdictions. The death certificates of 219 (20%) of these 1,117 patients made no mention of chronic renal failure. Overall, agreement on cause of death was poor (kappa = 0.22). Using ANZDATA information on cause of death and ABS underlying cause of death, only 38% of patients had the same cause (at the ICD-10 chapter level) recorded in both datasets. Additional information on primary renal disease (ANZDATA) and up to 12 associated causes of death (ABS) was required to obtain substantial agreement. CONCLUSION AND IMPLICATIONS: Death certificates and ANZDATA records provide differing causes of death for ESRD patients. Information from these sources was not directly comparable. Neither dataset provided a complete picture of renal disease as a cause of death in Australia.

Australia↗
PubMed1998

Beliefs concerning death, dying, and hastening death among older, functionally impaired Dutch adults: a one-year longitudinal study.

OBJECTIVES: Population surveys have documented increasing public support for euthanasia and assisted suicide but have not focused on the population of chronically ill older persons, obtained detailed sociocultural or health status information, or performed repeat assessments. This study seeks to describe the views of functionally-impaired Dutch elders on death, dying, and hastened death and to relate these to sociocultural and health status. DESIGN: One-year prospective epidemiologic survey. SETTING AND PARTICIPANTS: Community-dwelling participants in the longitudinal component of the Groningen Longitudinal Aging Study were assessed at home by interview and questionnaire in 1994 (n = 632) and again in 1995 (n = 575). MEASUREMENTS: Independent variables were sociocultural characteristics (eg, age, sex, income, education, religious affiliation, strength of religious belief), physical health status (number of chronic medical conditions, functional impairments), and mental health status (life satisfaction, self-efficacy, anxiety, depression, and neuroticism). Dependent variables were preoccupation with and fear of death, fears of the dying process, and attitudes toward hastened death. RESULTS: Low and stable rates of preoccupation with death and fear of death were found. Occasional but not persistent fears about the dying process were common. Fears of death and dying were most closely related to health status, especially mental health status. Views concerning hastening death were most strongly related to sociocultural variables, especially religious belief and affiliation. There was little change over the 1-year follow-up, with a trend toward less fears of death and dying and less support for hastened death. Significant changes in fears of death and dying and attitudes toward hastened death were not seen even in the 25% of subjects with the greatest deterioration in activities of daily living or greatest increase in anxiety and depression during the 1-year follow-up. CONCLUSION: Beliefs about death, dying, and hastened death are stable over 1-year follow-up. Fears of death and dying are most strongly related to mental health in this community sample. Attitudes about hastening death are primarily related to religious belief and secondarily to mental health. Mental health factors may determine the distress associated with the prospect of death and dying, whereas religion may dictate the actions considered proper when dying.

Aged↗
PubMed2002

Analysis of the sensitivity of death certificates in 440 hospital deaths: a comparison with necropsy findings.

BACKGROUND: There is current heightened public interest in issues surrounding death certification and necropsy. The present study was initiated to determine the accuracy of death certification in providing a correct diagnosis in a series of adult deaths occurring in hospital, all of which were followed by a necropsy. METHOD: We examined a series of 440 consecutive adult hospital necropsies performed at Addenbrooke's Hospital, without prior knowledge of the cause of death on the death certificate. The major causes of death at necropsy were subdivided on the basis of organ systems and subsequently compared with the cause of death stated on the death certificate. RESULTS: There were 448 stated causes of death on the death certificates, compared with 508 causes recorded at necropsy. The overall sensitivity of the death certificate in predicting an individual cause of death was 0.47, with sensitivities ranging from 0.90 in the neurological system to 0.28 in the cardiovascular system, and the sensitivity for all malignant causes of death was 0.65. No significant overall differences were noted in respiratory, gastrointestinal, malignant, and "other" systems when comparing causes of death on the death certificate with those at necropsy. CONCLUSIONS: There is a substantial discrepancy between the diagnosis given on death certificates compared with that at hospital necropsy. This paper discusses the importance of clinicopathological concordance and emphasises the importance of the necropsy in death certification.

Adult↗
PubMed1997

Heart disease deaths on death certificates re-evaluated by clinical records in a Japanese city.

In order to estimate the number of deaths from ischemic heart disease (IHD) in a Japanese city, we reevaluated heart disease deaths among residents aged 25-74 years by examining their clinical records. During the 2-year period from 1987 to 1988, 271 deaths among this population were attributed to heart disease. The recorded underlying cause of death was IHD in 96 cases, heart failure in 123 cases, and other heart disease in 52 cases. Re-evaluation of the cause of death yielded 57 cases of acute myocardial infarction (AMI), 85 cases of sudden death, 37 cases of heart disease other than IHD, and 63 cases of non-heart disease. In the remaining cases, there was insufficient information for evaluation. According to some autopsy studies, about 50% of sudden deaths are due to IHD. Thus, 50% of the number of sudden death cases may be added to the total number of IHD deaths. Accordingly, the total number of IHD deaths may have been 100, ie, 57 cases of AMI plus 43 cases of sudden death. The difference between the number of IHD deaths after re-evaluation and the number for which IHD was recorded as the underlying cause was small, with the former only 4% higher than the latter. The number of false-positives was equal to the number of false-negatives, and hence the number of IHD deaths recorded in this area seems to be close to the actual figure. We speculate that more accurate death certification will result in a decrease in the total number of deaths attributable to heart disease, as in 23% of deaths attributed to heart disease the underlying cause of death was not in fact heart disease.

Adult↗
PubMed2006

Deaths at Red Cross Children's Hospital, Cape Town 1999-2003--a study of death notification forms.

OBJECTIVES: The availability of cause-specific mortality data for children in South Africa is limited. Hospital-based data have the potential to contribute to understanding of the causation of childhood death in South Africa. The objectives of the study were to gain insights into the causes of death in a South African children's hospital. DESIGN: Prospective, descriptive study of death notification forms. SETTING: Red Cross War Memorial Children's Hospital, Cape Town. METHODS: Data from 1999 to 2003 were analysed by direct and underlying causes of death (using a modified Global Burden of Diseases (GBD) classification) and demographic variables. Death rates per 1 000 hospital admissions were calculated for certain common causes of death. Seasonal correlates of mortality were examined. RESULTS: There were 1 978 deaths. The number of deaths per year increased by 11.4% over the period. The death rate rose from 15.9 to 18.4 per 1 000 admissions from 1999 to 2002, declining to 17.4/1 000 in 2003. The death rate was higher for females than for males (18.4/1 000 versus 17.6/1 000, p = 0.007). Sixty per cent of deaths occurred in children less than 1 year old. GBD group I diseases (infectious, nutritional, perinatal) accounted for the greatest proportion of deaths (58.6%), followed by noncommunicable diseases (29.1%), and injuries (7.9%). HIV/AIDS accounted for 60% of infectious deaths (31.6% of all deaths). Diarrhoea-related mortality was 3 times higher in summer than in winter. Congenital conditions dominated GBD group II (57.5%). CONCLUSION: The analysis shows the value of routinely recording data on childhood hospital deaths. The results mirror those of the South African Medical Research Council's Burden of Disease studies but also reflect the hospital's tertiary functions. Female children were at higher risk of death. Childhood HIV-related deaths are a major challenge to the health system.

Age Distribution↗
PubMed2004

Desire for death and requests to hasten death of Japanese terminally ill cancer patients receiving specialized inpatient palliative care.

A desire for death and requests to hasten death are major topics in recent medical literature. The aim of this study was to clarify the bereaved family-reported incidence and reasons for desiring death and requests to hasten death during the whole course of terminally ill cancer patients receiving specialized palliative care in Japan. A nationwide questionnaire survey of 500 primary caregivers yielded a total of 290 responses (effective response rate, 62%). Sixty-two (21%) families reported that the patients had expressed a desire to die, and 29 (10%) families reported that the patients had requested that death be hastened. The major reasons for desiring death and requests to hasten death were: burden on others, dependency, meaninglessness, unable to pursue pleasurable activities, general malaise, pain, dyspnea, concerns about future distress, and wish to control the time of death. No intolerable physical symptoms were reported in 32% and 28% of the patients who desired death and those who requested to hasten death, respectively. Concerns about future distress and wishes to control the time of death were significantly more likely to be listed as major reasons for desiring death in patients who requested that death be hastened than those who did not. A desire for death and requests to hasten death are not uncommon in terminally ill cancer patients receiving specialized inpatient palliative care in Japan. More intensive strategies for general malaise, pain, and dyspnea near the end of life, and for feelings of being a burden, meaninglessness, and concerns about future distress would alleviate the serious suffering of patients with a desire for death. However, some patients with a strong wish to control the time of death might not receive benefit from conventional palliative care.

Adult↗
PubMed2000

Location of death (in-hospital or out-of-hospital) and type of death (arrhythmic, nonarrhythmic, noncardiac) after inducible sustained ventricular tachyarrhythmias after syncope, sustained ventricular tachycardia, or nonfatal cardiac arrest (the ESVEM trial).

The ESVEM Trial evaluated methods to guide antiarrhythmic drug use in patients with spontaneous, inducible sustained tachyarrhythmias at electrophysiologic testing and frequent ventricular premature complexes (VPCs) per hour (>/=10). We assessed the relation between location (in-hospital or out-of-hospital) and classification of death (arrhythmic, nonarrhythmic, cardiac and/or noncardiac) for 486 randomized patients. Deaths were classified as out-of-hospital arrhythmic deaths if arrhythmic death occurred out-of-hospital, or if an arrhythmia preceded hospital admission and directly caused death. Of the 486 randomized patients, 188 (39%) died during 6 years of follow-up. The location and type of death could be determined clearly in 171 patients (91%). Ninety-one deaths were in-hospital (53%); 80 were out-of-hospital (47%). Arrhythmic deaths occurred in 85% out-of-hospital patients and in 30% in-hospital patients (p <0.001). Baseline characteristics were comparable for patients with out-of-hospital and in-hospital arrhythmic deaths. Twenty-seven of 95 arrhythmic deaths occurred in-hospital (28%); 72% occurred out-of-hospital. Out-of-hospital arrhythmic death accounted for 40% of deaths for which location and type of information were available. The 1- and 4-year actuarial out-of-hospital arrhythmic death rates were 9% and 18%, respectively. Of nonarrhythmic cardiac deaths, 91% were in-hospital and 9% were out-of-hospital. Of noncardiac deaths, 74% were in-hospital and 26% were out-of-hospital. Similar results were seen in the 296 patients for whom a drug was considered to be effective. Thus, over half the deaths in the ESVEM trial occurred in-hospital. The long-term actuarial risk of out-of-hospital arrhythmic death in ESVEM was unexpectedly low.

Actuarial Analysis↗
PubMed2000

Validation of death certificate diagnosis of out-of-hospital coronary heart disease deaths in Olmsted County, Minnesota.

OBJECTIVE: To evaluate the validity of death certificate diagnosis of out-of-hospital (OOH) coronary heart disease (CHD) and sudden cardiac death (SCD) in Olmsted County, Minnesota, between 1981 and 1994. METHODS: In this review of the medical records, autopsy reports, and coroner's files, OOH deaths with heart disease as the underlying cause of death on the death certificate were classified into CHD (International Classification of Diseases, 9th Revision, Clinical Modification [ICD-9-CM] codes 410-414) and non-CHD (other ICD-9-CM heart disease codes) deaths. A 10% random sample (n = 174) of these death certificates was reviewed by physicians, and published validation criteria were applied to classify these deaths into validated CHD or non-CHD categories. Sudden cardiac death was defined as validated CHD that occurred at an OOH location with less than 24 hours between symptom onset and death. RESULTS: The death certificate definition of OOH CHD death (ICD-9-CM codes 410-414) had high sensitivity and positive predictive value of 91% and 96%, respectively. The specificity and the negative predictive value were slightly lower at 86% and 72%, respectively. The sensitivity of death certificate diagnosis of CHD for validated SCD was 89%, and the positive predictive value was 77%. Using a more restrictive definition of SCD, that is, less than 1 hour between the onset of symptoms and death, the positive predictive value of CHD codes for SCD was lower at 52%. CONCLUSIONS: In Olmsted County, the positive predictive values of death certificate diagnosis for OOH CHD and SCD are high. Relying on death certificate diagnoses results in about 5% underestimation of the true CHD rates, whereas their use as a surrogate for SCD yields a 16% overestimation of the true SCD rates.

Autopsy↗
PubMed2006

Pregnancy-related deaths in four regions of Europe and the United States in 1999-2000: characterisation of unreported deaths.

OBJECTIVE: We compared official maternal mortality statistics with those from a special study covering all pregnancy-associated deaths in two European countries (Finland and France) and in two US states (Massachusetts and North Carolina) in 1999-2000 to characterize pregnancy-related deaths that are not included in official statistics. STUDY DESIGN: We linked the official ICD-10-based maternal mortality data for 84 deaths with study data on 404 pregnancy-associated deaths. RESULTS: Of the pregnancy-associated deaths, 151 were pregnancy-related. We found 69 pregnancy-related deaths that had not been included as maternal deaths, and two deaths coded as maternal deaths that did not meet our definition for a pregnancy-related death. In total, 58 of these 69 deaths were from medical causes and 11 were from external causes or injuries (10 postpartum depression-related suicides and one accidental drug poisoning). The unreported deaths due to medical causes included 27 direct, 15 indirect, and two direct/indirect pregnancy-related deaths and 14 possibly pregnancy-related deaths. The most common causes of the unreported deaths due to medical causes were intracerebral hemorrhage (7 deaths), peripartum cardiomyopathy (4), pulmonary embolism (4) and pregnancy-induced hypertension (4). CONCLUSIONS: The collection of data on pregnancy-related and pregnancy-associated deaths is useful for countries with low maternal mortality figures. The use of various data-collection methods may substantially increase the quality of maternal mortality statistics.

Female↗
PubMed2001

The validity of death certificates: routine validation of death certification and its effects on mortality statistics.

The 3478 death certificates (7.1% of all annual death certificates) of this study comprise those national death certificates in 1995 submitted for validation to the panel representing both medical and nosological expertise. As such, it is highly selected and represents, from the nosological point of view, the most inconsistently filled-in portion of Finnish death certificates. The routine validation procedure is essentially based on exploitation of the extra medical information, i.e. the case history, on the Finnish death certificate form. Altogether, 2813 (80.9%) out of 3478 certificates could be adjusted at the primary panel session; the rest required further clarification. The re-assignment of cause of death by the panel and the impact of panel adjustments on the national mortality statistics is assessed here by comparing the initial death certification and the finally registered underlying cause of death grouped into ICD-9 major categories with special reference to the subcategories of neoplasm, cardiovascular disease (HVD) and unnatural death. A statistically significant decline (p<0.0001) in deaths, both in the category of symptoms, signs and ill-defined conditions and in the pulmonary circulation disease subcategory of HVD with 37.6 and 35.1%, respectively, was observed. The decrease of 11.1% in the benign or NUD neoplasm subcategory and the increase of 8.6 and 7.0% in the categories of endocrine disease, and musculo-skeletal and connective tissue disease, respectively, are essential observations as to the quality of the cause of death register. The effect on the HVD major category was practically nil. At the HVD-subcategorial level, a decrease of 14.0% for diseases of the veins and lymphatics and other circulatory diseases and an increase of 3.5% for hypertensive diseases (HYP) were the two next most obvious alterations to the diseases of the pulmonary circulation, but were without statistical significance. For ischaemic heart disease and other subcategories, the effects were minor. The unnatural deaths as a whole increased in the final statistics with only 0.9%. In the study data, categorial changes ranged from the decrease of 75.2% for symptoms, signs and ill-defined conditions to the increase of 77.3% for endocrine diseases. In conclusion, the Finnish death certificate form, death certification practices and cause of death validation procedure seem to serve the coding of causes of death for mortality statistics appropriately. The results of the study form a relevant reference background to evaluation of epidemiological studies on mortality.

Abstracting and Indexing↗
PubMed1997

Competing causes of death: a death certificate study.

BACKGROUND: Despite the widespread interest in competing causes of death, empirical information on interrelationships between causes of death is scarce. We have used death certificate information to estimate the prevalence of competing causes of death at the moment of dying from specific underlying causes of death. MATERIALS AND METHODS: In a stratified sample of 5975 deaths occurring in The Netherlands in 1990, information contained in the death certificate was used to determine the presence of diseases which, in the hypothetical case of elimination of the underlying cause of death, could develop into a new underlying cause of death. Poisson regression analysis was used to describe variation in age- and sex-adjusted prevalence of competing causes of death between different underlying causes. RESULTS: Per 100 deaths, 46.2 competing causes were identified (52.0 after reweighting to take away the effects of stratification). The most frequent competing causes, all occurring in more than 2% of deaths, were: senile dementia, diabetes mellitus, ischemic heart disease, cerebrovascular disease, chronic obstructive lung disease, hypertensive disease, and arteriosclerosis. The overall prevalence of competing causes is relatively high among deaths from respiratory diseases (relative risk for respiratory diseases as compared with all underlying causes (RR) = 1.42 (95% CI, 1.25-1.62)), relatively low among deaths from neoplasms (RR = 0.54 (95% CI, 0.47-0.62)), and in between among deaths from cardiovascular diseases (RR = 1.08 (95% CI, 0.95-1.22)). CONCLUSION: Although it cannot be excluded that some of the variation in prevalence of competing causes by underlying cause is due to selective underregistration of coexisting diseases on death certificates, the results of this study suggest that conventional estimates of gains in life expectancy after elimination of neoplasms are much less biased by the effect of competing causes than the corresponding estimates for cardiovascular diseases and particularly respiratory diseases.

Adolescent↗
PubMed1999

Mechanisms of death in the CABG Patch trial: a randomized trial of implantable cardiac defibrillator prophylaxis in patients at high risk of death after coronary artery bypass graft surgery.

BACKGROUND: The CABG Patch trial compared prophylactic implantable cardiac-defibrillator (ICD) implantation with no antiarrhythmic therapy in coronary bypass surgery patients who had a left ventricular ejection fraction <0.36 and an abnormal signal-averaged ECG. There were 102 deaths among the 446 ICD group patients and 96 deaths among the 454 control group patients, a hazard ratio of 1.07 (P=0.63). The mechanisms of death were classified, and hypotheses were tested about the effects of ICD therapy on arrhythmic and nonarrhythmic cardiac deaths in the CABG Patch Trial and the Multicenter Automatic Defibrillator Implantation Trial (MADIT). METHODS AND RESULTS: The 198 deaths in the trial were reviewed by an independent Events Committee and classified by the method of Hinkle and Thaler. Only 54 deaths (27%) occurred out of hospital; 145 deaths (73%) were witnessed. Seventy-nine (82%) of the 96 deaths in the control group and 76 (75%) of the 102 deaths in the ICD group were due to cardiac causes. Cumulative arrhythmic mortality at 42 months was 6.9% in the control group and 4.0% in the ICD group (P=0. 057). Cumulative nonarrhythmic cardiac mortality at 42 months was 12. 4% in the control group and 13.0% in the ICD group (P=0.275). Death due to pump failure was significantly associated with death >1 hour from the onset of symptoms, dyspnea within 7 days of death, and overt heart failure within 7 days of death. CONCLUSIONS: In the CABG Patch Trial, ICD therapy reduced arrhythmic death 45% without significant effect on nonarrhythmic deaths. Because 71% of the deaths were nonarrhythmic, total mortality was not significantly reduced.

Anti-Arrhythmia Agents↗