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N R Every

Publications and source records attributed to N R Every.

At least 37 records · Page 2Linked to original sources
PubMed2000

Early angiography versus conservative treatment in patients with non-ST elevation acute myocardial infarction: MITI Investigators. Myocardial Infarction Triage and Intervention.

OBJECTIVES: To compare short- and long-term outcome after early invasive or conservative strategies in the treatment of non-ST segment elevation acute myocardial infarction (AMI). BACKGROUND: It is uncertain whether or not there is benefit from emergent invasive diagnosis and treatment of AMI in patients without ST segment elevation on the admission electrocardiogram (ECG). METHODS: In a cohort of 1,635 consecutive patients with AMI who presented to hospitals without ST segment elevation on their admission ECG, we compared treatments, hospital course and outcome in 308 patients who presented to hospitals whose initial strategy favored early angiography and appropriate intervention when indicated versus 1,327 similar patients who presented to hospitals that favor a more conservative initial approach. RESULTS: At baseline, patients admitted to hospitals favoring an early invasive strategy were younger, more predominately Caucasian and had less comorbidity. Early coronary angiography occurred in 58.8% versus 8% (p < 0.001), and early angioplasty was performed in 44.8% versus 6.1% (p < 0.001) in the two different cohorts. Patients treated in hospitals favoring the early invasive strategy had a lower 30-day (5.5% vs. 9.5%, p = 0.026) and four-year mortality (20% vs. 37%, p < 0.001). Multivariate analysis showed a trend towards lower hospital mortality (OR = 0.56, 95% CI: 0.29 to 1.09) and a significant lower long-term mortality (hazard ratio = 0.61, 95% CI: 0.47 to 0.80) in patients admitted to hospitals favoring an early invasive strategy. CONCLUSIONS: These data suggested that an early invasive strategy in patients with AMI and nondiagnostic ECG changes is associated with lower long-term mortality.

Aged↗
PubMed2000

Treatment and outcome of myocardial infarction in hospitals with and without invasive capability. Investigators in the National Registry of Myocardial Infarction.

OBJECTIVES: We sought to determine the extent to which the capability of a hospital to perform invasive cardiovascular procedures influences treatment and outcome of patients admitted with acute myocardial infarction (AMI). BACKGROUND: Patients with AMI are usually transported to the closest hospital. However, relatively few hospitals have the capability for immediate coronary arteriography, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft surgery (CABG), should these interventions be needed. METHODS: The 1,506 hospitals participating in the National Registry of Myocardial Infarction 2 were classified according to their highest level of invasive capability: 1) none (noninvasive, 28.1%); 2) coronary arteriography (cath-capable, 25.2%); 3) coronary angioplasty (PTCA-capable, 7.4%); and 4) bypass surgery (CABG-capable, 39.2%). Treatment and in-hospital outcomes were assessed for 305,812 patients admitted from June 1994 through October 1996. Follow-up through 90 days was ascertained in a subset of 30,402 patients enrolled simultaneously in both the National Registry of Myocardial Infarction (NRMI) 2 and the Cooperative Cardiovascular Project (CCP). RESULTS: The proportion of patients receiving initial reperfusion intervention was only slightly higher at the more invasive hospitals (noninvasive 32.5%, cath-capable 31.2%, PTCA-capable 32.9% and CABG-capable 35.9%, p < 0.001 by chi-square statistic). Among thrombolytic recipients, median door-to-drug time interval differed little among hospital types and ranged from 42 to 45 minutes. At cath-capable, PTCA-capable and CABG-capable hospitals, coronary arteriography was performed in 32.9%, 37.4% and 64.9%, respectively, and PTCA in 0.0%, 5.1% and 31.4%, both p < 0.001 by chi-square statistic. The proportion of patients transferred out to other facilities was 51.0%, 42.2%, 39.9% and 4.4% (p < 0.0001) among noninvasive, cath-capable, PTCA-capable and CABG-capable hospitals, respectively. Among patients in the combined NRMI and CCP data set, mortality at 90 days postinfarction was similar among patients initially admitted to each of the four hospital types. CONCLUSIONS: Although patients with AMI admitted to hospitals without invasive cardiac facilities have a high likelihood of subsequent transfer to other facilities, their likelihood of receiving a reperfusion intervention at the first hospital, their door to thrombolytic drug intervals and their 90-day survival rates are similar to those of patients initially admitted to more invasively equipped hospitals. These data suggest that a policy of initial treatment of myocardial infarction at the closest medical facility is appropriate medical practice.

Aged↗
PubMed2000

Quality Enhancement Research Initiative in ischemic heart disease: a quality initiative from the Department of Veterans Affairs. QUERI IHD Executive Committee.

Despite the dramatic fall in ischemic heart disease (IHD) mortality rates over the last 3 decades, it remains the number one cause of death in the United States, and one of the most frequent indications for care by the US Department of Veterans Affairs. National practice guidelines have been developed and disseminated both by societies that specialize in cardiology and within the Veterans Health Administration. Despite these efforts, a substantial minority remains of patients with IHD who are not treated with guideline-recommended therapies. The Quality Enhancement Research Initiative in IHD is a Veterans Health Administration-sponsored initiative to address the gap between guideline-recommended therapies and actual Department of Veterans Affairs practice. Because guideline development for patients with IHD is relatively mature, the Quality Enhancement Research Initiative in IHD will concentrate on measuring existing practices, implementing interventions, and evaluating outcomes in veterans with IHD. Measurement of existing practices will be evaluated through analyses of existing Veterans Affairs databases developed for the Continuous Improvement in Cardiac Surgery Program, as well as data collected at the Center for the Study of Practice Patterns in veterans with acute myocardial infarction. To measure existing practices in outpatients with IHD, we plan to develop a new database that extracts electronic data from patient laboratory and pharmacy records into a relational database. Interventions to address gaps between guideline recommendations and actual practice will be solicited and implemented at individual medical centers. We plan to emphasize point-of-care electronic reminders as well as online decision support as methods for improving guideline compliance.

Benchmarking↗
PubMed2000

The association between institutional primary angioplasty procedure volume and outcome in elderly Americans.

BACKGROUND: The association between greater procedure volume and improved patient outcome in cardiac procedures has been established in percutaneous transluminal coronary angioplasty (PTCA), coronary stent placement and coronary bypass surgery. The association between primary angioplasty volume and outcome has not been evaluated. METHODS: We evaluated the association between the volume of primary angioplasty procedures with short- and long-term outcome in 6,124 patients with documented acute myocardial infarction. Patients without shock on presentation treated with primary coronary angioplasty within 12 hours of hospital admission were selected from consecutive infarct patients included in the Cooperative Cardiovascular Project database. Patients were divided into quartiles based on the volume of primary PTCA procedures performed at their admitting hospital. RESULTS: The majority of United States (US) hospitals performed less than three primary PTCA procedures per month. Patients admitted to hospitals in the lowest volume quartile of primary PTCA had 31% higher 30-day mortality than those admitted to the highest volume quartile. After adjustment for baseline differences in patient characteristics, there was an association between admission to higher volume primary PTCA hospitals and lower 30-day mortality (odds ratio per volume quartile = 0.91; 95% confidence interval = 0.83-0.99). CONCLUSION: Eighty-two percent of US hospitals perform less than three primary PTCA procedures per month. In elderly Americans treated with primary PTCA, we observed an association between admission to higher volume hospitals and lower short- and long-term mortality. This association was independent of total PTCA volumes.

Aged↗
PubMed1999

Differences between men and women in the management of unstable angina pectoris (The GUARANTEE Registry). The GUARANTEE Investigators.

Few data are available in prospectively collected cohorts of patients with unstable angina pectoris or on the use of appropriate medications or interventions. Accordingly, we evaluated 2,948 consecutive patients with unstable angina admitted to 35 hospitals in the United States in 1996, and comparing men and women (39% of the patients were women). Differences were seen in coronary risk profiles with a higher incidence of systemic hypertension, diabetes mellitus, and a family history of coronary disease in women. Women were less likely to receive Agency for Health Care Policy Research (AHCPR) recommended pharmacologic treatment than men. Cardiac catheterization, coronary angioplasty, and bypass was performed less often in women compared with men (44% vs. 53%, p = 0.002; 12% vs. 18%, p = 0.02; 7% vs. 10%, p = 0.001, respectively). At catheterization, women were more likely to have no significant coronary artery disease (25% vs. 14%, p = 0.001). Although fewer women than men fulfilled the AHCPR criteria for cardiac catheterization (54% vs. 64%, p = 0.001), a similar rate of men and women with positive criteria underwent catheterization and angioplasty. However, fewer women with positive criteria underwent bypass surgery (36% vs. 46%, p = 0.03). More men "ruled-in" for a myocardial infarction at admission (13% vs. 8%, p = 0.001), but there was no difference in recurrent angina, in-hospital myocardial infarction, or death. Despite different epidemiologic profiles and less evidence of coronary artery disease by noninvasive and invasive tests, women and men had similar outcomes.

Adult↗
PubMed1999

Early use of ACE inhibitors in the treatment of acute myocardial infarction in the United States: experience from the National Registry of Myocardial Infarction 2. National Registry of Myocardial Infarction 2 participants.

This study was undertaken to examine recent trends in the use of angiotensin-converting enzyme (ACE) inhibitors within 24 hours of admission in patients hospitalized for acute myocardial infarction (AMI) and to identify clinical factors associated with ACE inhibitor-prescribing patterns. Demographic, procedural, and acute medication use from 202,438 patients with AMI were collected at 1,470 US hospitals participating in the National Registry of Myocardial Infarction 2 from June 1994 through June 1996. Acute ACE inhibitor use increased from 14.0% in 1994 to 17.3% in 1996. After controlling for all important clinical variables, we found that there was a significant increase in the odds of acute ACE inhibitor treatment over time (odds ratio [OR]1.07 for each 180-day period; 95% confidence intervals [CI] 1.06 to 1.08; p<0.0001). Univariate data suggested that patients treated acutely with ACE inhibitors tended to be older (70.9 vs. 67.2 years) and had lower rates of in-hospital mortality (8.8% vs. 11.0%). Independent predictors of receiving an ACE inhibitor acutely included anterior wall infarction (OR 1.36; 95% CI 1.32 to 1.40), Killip class 2 or 3 (OR 1.77; 95% CI 1.72 to 1.83), prior myocardial infarction (OR 1.33; 95% CI 1.30 to 1.37), prior history of congestive heart failure (OR 1.88; 95% CI 1.82 to 1.95), and diabetes mellitus (OR 1.34; 95% CI 1.30 to 1.38). Physicians are prescribing ACE inhibitors acutely in patients with AMI with increasing frequency. Patients with evidence of congestive heart failure and those with anterior myocardial infarction have the greatest expected benefit from such therapy, and these persons receive such treatment most often. However, most patients hospitalized with AMI do not receive this potentially life-saving therapy.

Aged↗
PubMed1999

Trends in the post-hospitalization medical treatment of unstable angina pectoris: 1990 to 1995.

This study provides data on post-hospitalization medication treatment trends for unstable angina between 1990 and 1995. We conducted an observational cohort study at the Veterans Affairs Puget Sound Health Care System (VAPSHCS). Computerized records of hospital discharges and cardiac catheterizations were used to identify unstable angina diagnoses among veterans between 1990 and 1995. Discharge medications issued within 90 days after discharge were ascertained from computerized outpatient pharmacy records. Of the 1,100 veterans discharged with unstable angina, 885 (80%) filled a prescription through the VAPSHCS within 90 days after discharge. Neither use of aspirin nor use of beta blockers increased between 1990 and 1995: overall use averaged 76% for aspirin (78% of those without potential contraindications) and 32% for beta blockers (36% of those without potential contraindications). Use of non-dihydropyridine calcium antagonists--primarily diltiazem--decreased from 57% to 40% (p <0.01), whereas use of dihydropyridine calcium antagonists increased from 12% to 26% (p <0.01). Thus, pharmacy records indicated that aspirin use was high although it was lower than expected, possibly due to ready availability outside the VAPSHCS pharmacy. The low frequency of beta-blocker use and the increasing reliance on dihydropyridine calcium antagonists through 1995 to treat unstable angina may be an opportunity to improve veteran care according to Agency for Health Care Policy Research recommendations.

Adrenergic beta-Antagonists↗
PubMed1999

Primary coronary angioplasty vs thrombolysis for the management of acute myocardial infarction in elderly patients.

CONTEXT: Despite evidence from randomized trials that, compared with early thrombolysis, primary percutaneous transluminal coronary angioplasty (PTCA) after acute myocardial infarction (AMI) reduces mortality in middle-aged adults, whether elderly patients with AMI are more likely to benefit from PTCA or early thrombolysis is not known. OBJECTIVE: To determine survival after primary PTCA vs thrombolysis in elderly patients. DESIGN: The Cooperative Cardiovascular Project, a retrospective cohort study using data from medical charts and administrative files. SETTING: Acute care hospitals in the United States. PATIENTS: A total of 20683 Medicare beneficiaries, who arrived within 12 hours of the onset of symptoms, were admitted between January 1994 and February 1996 with a principal discharge diagnosis of AMI, and were eligible for reperfusion therapy. MAIN OUTCOME MEASURES: Thirty-day and 1-year survival. RESULTS: A total of 80356 eligible patients had an AMI at hospital arrival and met the inclusion criteria, of whom 23.2% received thrombolysis and 2.5% underwent primary PTCA within 6 hours of hospital arrival. Patients undergoing primary PTCA had lower 30-day (8.7% vs 11.9%, P=.001) and 1-year mortality (14.4% vs 17.6%, P=.001). After adjusting for baseline cardiac risk factors and admission and hospital characteristics, primary PTCA was associated with improved 30-day (hazard ratio [HR] of death, 0.74; 95% confidence interval [CI], 0.63-0.88) and 1-year (HR, 0.88; 95% CI, 0.73-0.94) survival. The benefits of primary coronary angioplasty persisted when stratified by hospitals' AMI volume and the presence of on-site angiography. In patients classified as ideal for reperfusion therapy, the mortality benefit of primary PTCA was not significant at 1-year follow-up (HR, 0.92; 95% CI, 0.78-1.08). CONCLUSION: In elderly patients who present with AMI, primary PTCA is associated with modestly lower short- and long-term mortality rates. In the subgroup of patients who were classified as ideal for reperfusion therapy, the observed benefit of primary PTCA was no longer significant.

Aged↗
PubMed1999

Sex-based differences in early mortality after myocardial infarction. National Registry of Myocardial Infarction 2 Participants.

BACKGROUND: There is conflicting information about whether short-term mortality after myocardial infarction is higher among women than among men after adjustment for age and other prognostic factors. We hypothesized that younger, but not older, women have higher mortality rates during hospitalization than their male peers. METHODS: We analyzed data on 384,878 patients (155,565 women and 229,313 men) who were 30 to 89 years of age and who had been enrolled in the National Registry of Myocardial Infarction 2 between June 1994 and January 1998. Patients who had been transferred from or to other hospitals were excluded. RESULTS: The overall mortality rate during hospitalization was 16.7 percent among the women and 11.5 percent among the men. Sex-based differences in the rates varied according to age. Among patients less than 50 years of age, the mortality rate for the women was more than twice that for the men. The difference in the rates decreased with increasing age and was no longer significant after the age of 74 (P< 0.001 for the interaction between sex and age). Logistic-regression analysis showed that the odds of death were 11.1 percent greater for women than for men with every five-year decrease in age (95 percent confidence interval, 10.1 to 12.1 percent). Differences in medical history, the clinical severity of the infarction, and early management accounted for only about one third of the difference in the risk. After adjustment for these factors, women still had a higher risk of death for every five years of decreasing age (increase in the odds of death, 7.0 percent; 95 percent confidence interval, 5.9 to 8.1 percent). CONCLUSIONS: After myocardial infarction, younger women, but not older women, have higher rates of death during hospitalization than men of the same age. The younger the age of the patients, the higher the risk of death among women relative to men. Younger women with myocardial infarction represent a high-risk group deserving of special study.

Adult↗
PubMed1999

Association between percutaneous transluminal coronary angioplasty volumes and outcomes in the Healthcare Cost and Utilization Project 1993-1994.

Studies from a variety of settings have indicated that outcomes for coronary angioplasty are improved when performed in institutions with high caseloads (> 400/year). The purpose of this investigation was to examine the volume outcome hypothesis for coronary angioplasty in a 20% stratified sample of acute care, non-federal hospitals in 17 states. Data were derived from the Nationwide Inpatient Sample from the Health Care Cost and Utilization Project releases 2 and 3. From these records, 163,527 angioplasties from 214 hospitals were selected. Outcomes included hospital mortality, same-admission coronary artery bypass surgery, and a combined end point of either death or same-admission surgery, or both. Hospital volumes were defined as low (< or = 200 cases/year), medium (201 to 400), and high (> 400). Analyses were conducted separately for patients with and without a principal discharge diagnosis of acute myocardial infarction (AMI). For both AMI and no-AMI groups, the rates of adverse outcomes were generally lower in high-volume institutions, and this finding was true in both univariate and multivariate analyses. Although 27% of hospitals were in the low-volume category, only 5% of all procedures were performed in these institutions. Projecting to all United States hospitals for the 2 years, if all procedures performed in low-volume centers had been done in high-volume institutions, 137 deaths could have been averted (90 AMIs, 47 no-AMIs) as well as 404 (46 AMIs, 358 no-AMIs) same-admission surgeries. The results of this study support the hypothesis that better results are obtained in higher volume institutions, but also show that in 1993 and 1994, relatively few patients had their procedures performed in low-volume institutions.

Angioplasty, Balloon, Coronary↗
PubMed1999

Racial differences in the management of unstable angina: results from the multicenter GUARANTEE registry.

BACKGROUND: Prior studies, usually conducted with the use of insurance databases, have shown differences in the use of cardiac procedures between black patients and white patients hospitalized with various types of coronary artery disease. However, few data are available in prospectively collected cohorts of patients with unstable angina or on the use of appropriate medications or interventions. METHODS AND RESULTS: We evaluated 2948 consecutive patients with unstable angina admitted to 35 hospitals across the United States in 1996, comparing nonwhite and white patients. Seventy-seven percent of patients were white, 14% were black, 4% were Hispanic, 1% were Asian, and 3% were other or unknown race. Differences were seen in coronary risk profile, with a higher incidence of hypertension and diabetes mellitus in nonwhites. Cardiac catheterization was performed less often in nonwhites compared with whites (36% vs 53%, P =.001). Even in patients meeting the criteria for appropriate catheterization in the Agency for Health Care Policy Research unstable angina guidelines, fewer nonwhites underwent catheterization (44% vs 61%, P =.001), but among these, fewer nonwhites had significant coronary stenosis (72% vs 90%, P =.001). However, among patients catheterized who had indications for revascularization, angioplasty and coronary artery bypass grafting were performed equally often in nonwhites and whites. CONCLUSIONS: Current guidelines would recommend more aggressive use of cardiac catheterization for nonwhite patients. However, our findings suggest that racial differences may need to be included in the diagnostic and interventional algorithms.

Aged↗
PubMed1999

Coronary artery stent outcomes in a Medicare population: less emergency bypass surgery and lower mortality rates in patients with stents.

BACKGROUND: Randomized trials of coronary stents versus conventional balloon angioplasty have demonstrated improved short- and long-term outcomes for selected patients receiving stents. The purpose of this study was to compare outcomes in patients receiving stents with those undergoing conventional balloon angioplasty in everyday clinical practice. METHODS AND RESULTS: This study uses information from the Medicare Provider Analysis and Review files for fiscal years 1994 and 1996, the first year the coronary stent code was used. For patients 65 years of age and older, 165,657 cases in 1994 and 201,869 in 1996, including 74,836 cases with stent placement, were identified. Outcomes included hospital deaths, use of same- admission coronary artery bypass surgery, and either or both. Analyses were performed separately for those with and those without a principal diagnosis of acute myocardial infarction. Hospital mortality rates were similar in both years, but the use of same-admission coronary artery bypass surgery was lower in 1996. In that year, for both patients with and those without acute myocardial infarction, hospital death and the use of same-admission coronary artery bypass surgery were lower in the stent group. Additionally, results in the stent group were generally better at high-volume (>200 cases per year) institutions, as was the case for the prestent, 1994 results. CONCLUSIONS: This study documents improved short-term outcomes in older patients who undergo coronary stent placement. Stenting did not eliminate the finding of improved outcomes at high-volume centers.

Aged↗
PubMed1999

Efegatran sulfate as an adjunct to streptokinase versus heparin as an adjunct to tissue plasminogen activator in patients with acute myocardial infarction. ESCALAT Investigators.

BACKGROUND: Previous clinical studies have shown that direct antithrombins can accelerate clot lysis after treatment with streptokinase in acute myocardial infarction (MI). Efegatran is a new direct antithrombin, which in experimental animals has been shown to enhance thrombolysis, reduce rate of reocclusion, and limit infarct size. This study was designed to compare the efficacy of efegatran plus streptokinase versus heparin plus accelerated tissue plasminogen activator (TPA) in coronary reperfusion in acute MI. METHODS AND RESULTS: In this randomized, dose-finding study (n = 245), we initially explored 4 doses of efegatran sulfate in combination with streptokinase (1.5 million U) given intravenously within 12 hours of symptom onset. The optimal dosage group of 0.5 mg/kg per hour was expanded and compared with heparin plus accelerated TPA. The primary end point was complete patency (Thrombolysis In Myocardial Infarction [TIMI] grade 3) at 90 minutes after thrombolytic therapy, assessed in a core angiographic laboratory. Infarct-related vessel patency (TIMI grade 2 or 3) and complete patency (TIMI grade 3) were 73% and 40% in the efegatran/streptokinase group versus 79% and 53% in the heparin/TPA group (P = not significant). In-hospital mortality rate was 5% for the efegatran/streptokinase group versus 0% for the heparin/TPA group (P = not significant). Major bleeding occurred in 23% of patients in the efegatran/streptokinase group versus 11% in the heparin/TPA group (P = not significant). No intracranial hemorrhage occurred. CONCLUSIONS: The combination of efegatran plus streptokinase is not superior to the current therapy of heparin and accelerated TPA in achieving early patency. In addition, there is no indication that this experimental treatment can achieve better clinical outcome.

Antithrombins↗
PubMed1999

A comparison of the national registry of myocardial infarction 2 with the cooperative cardiovascular project.

OBJECTIVES: This study was performed to evaluate whether or not the simpler case identification and data abstraction processes used in National Registry of Myocardial Infarction two (NRMI 2) are comparable with the more rigorous processes utilized in the Cooperative Cardiovascular Project (CCP). BACKGROUND: The increased demand for quality of care and outcomes data in hospitalized patients has resulted in a proliferation of databases of varying quality. For patients admitted with myocardial infarction, there are two national databases that attempt to capture critical process and outcome data using different case identification and abstraction processes. METHODS: We compared case ascertainment and data elements collected in Medicare-eligible patients included in the industry-sponsored NRMI 2 with Medicare enrollees included in the Health Care Financing Administration-sponsored CCP who were admitted during identical enrollment periods. Internal and external validity of NRMI 2 was defined using the CCP as the "gold standard." RESULTS: Demographic and procedure use data obtained independently in each database were nearly identical. There was a tendency for NRMI 2 to identify past medical histories such as prior infarct (29% vs. 31%, p < 0.001) or heart failure (21% vs. 25%, p < 0.001) less frequently than the CCP. Hospital mortality was calculated to be higher in NRMI 2 (19.7% vs. 18.1%, p < 0.001) due mostly to the inclusion of noninsured patients 65 years and older in NRMI 2. CONCLUSIONS: We conclude that the simpler case ascertainment and data collection strategies employed by NRMI 2 result in process and outcome measures that are comparable to the more rigorous methods utilized by the CCP. Outcomes that are more difficult to measure from retrospective chart review such as stroke and recurrent myocardial infarction must be interpreted cautiously.

Aged↗
PubMed1999

Thrombolysis versus primary angioplasty in older patients with acute myocardial infarction.

Although it is effective for appropriate older patients with acute myocardial infarction (AMI), only about 25% of patients 65 years and older are eligible for thrombolytic therapy. Primary percutaneous transluminal coronary angioplasty (PTCA) may be a suitable alternative reperfusion therapy, particularly for older patients with high risk of intracerebral haemorrhage or cardiogenic shock. Randomised trials of primary PTCA versus thrombolytic therapy have demonstrated better efficacy for primary PTCA, whereas the 2 therapies produced comparable results in observational studies. In subset analyses in 2 randomised trials, there were trends toward better outcomes with primary PTCA, although these studies had small numbers of older patients. Results from 3 AMI registries (the Cooperative Cardiovascular Project, the Myocardial Infarction Triage and Intervention Registry, and the National Registry of Myocardial Infarction 2) indicated trends toward improved hospital or 30 day death rates in patients 75 years and older receiving primary PTCA. Older patients who are at high risk of bleeding complications may do better with primary PTCA, although for others with moderate or minimal risk, the 2 therapies are equivalent. More data about long term follow-up and the association between outcomes and hospital and operator volumes for primary PTCA in older patients are needed before a definitive recommendation can be made.

Age Factors↗
PubMed1999

The Food and Drug Administration and atrial defibrillation devices.

CONTEXT: Atrial fibrillation is a common arrhythmia. It leads to significant morbidity and mortality, primarily from the increased incidence of stroke. The implantable atrial defibrillator, a new therapeutic option for the management of atrial fibrillation, is currently undergoing Food and Drug Administration (FDA) scrutiny for approval to market in the United States. DATA SOURCES: A review of the basic epidemiology of atrial fibrillation, as well as the current status of accepted treatment options in light of the development of the implantable atrial defibrillator, was conducted. A literature search using the terms atrial fibrillation, implantable defibrillator, Food and Drug Administration, medical devices, and medical device regulatory law was conducted using the MEDLINE and Current Contents databases. RESULTS: Currently, there is no consensus on the optimal treatment of atrial fibrillation. Despite the lack of definitive studies showing overall benefit associated with maintaining sinus rhythm in patients in atrial fibrillation, the implantable atrial defibrillator may soon reach the general market. We examine the FDA process for the evaluation of this new medical device and discuss implications for the patient, physician, industry, and health insurers. CONCLUSIONS: Current FDA approval processes for new devices are a compromise between (a) the needs for expediency and encouraging innovation by the medical device industry and (b) the need to ensure that new devices will contribute to improved patient outcomes. We suggest alternative FDA-approval processes that address these issues.

Atrial Fibrillation↗