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Biomedical subjects

S E Kimmel

Publications and source records attributed to S E Kimmel.

At least 19 recordsLinked to original sources

Sex and myocardial infarction: an epidemiologic perspective.

The relation between sexual activity and acute myocardial infarction (MI) risk is one of great interest to people at risk for MI and their physicians. However, understanding this relation requires an appreciation of the complex interplay among relative, attributable, and absolute risk. Because there is an underlying risk of MI in the population, the risk of MI after sexual activity must be compared with this underlying baseline risk. The estimated relative risk of MI after sexual activity is approximately 2.5 during the 2-hour period after sex, indicating a 2.5-fold increase in risk over baseline. However, because the baseline risk during any 2-hour period is very low, the absolute increase in risk (the risk from sexual activity minus the baseline risk), is extremely small (e.g., 0.01% over a year for low-risk individuals engaging in weekly sexual activity and 0.1% for higher-risk individuals). In addition, the attributable risk (the percentage of MIs due to sexual activity) is <1%. Thus, any individual's risk of MI during sexual activity is low. Nonetheless, factors that may decrease the risk of MI after sexual activity are important to explore, and include regular exercise and perhaps medication use, such as aspirin and beta blockers. Although there may be a long-term cardiovascular and mortality benefit to regular sexual activity, current data supporting this theory are limited. This article describes the relation between sexual activity and acute MI with respect to the complex interplay among relative, attributable, and absolute risk. Limitations of studies examining the potential long-term benefits of regular sexual activity are also discussed.

Adult↗

Management of sexual dysfunction in patients with cardiovascular disease: recommendations of the Princeton Consensus Panel.

Sexual dysfunction is highly prevalent in both sexes and adversely affects patients' quality of life and well being. Given the frequent association between sexual dysfunction and cardiovascular disease, in addition to the potential cardiac risk of sexual activity itself, a consensus panel was convened to develop recommendations for clinical management of sexual dysfunction in patients with cardiovascular disease. Based upon a review of the research and presentations by invited experts, a classification system was developed for stratification of patients into high, low, and intermediate categories of cardiac risk. The large majority of patients are in the low-risk category, which includes patients with (1) controlled hypertension; (2) mild, stable angina; (3) successful coronary revascularization; (4) a history of uncomplicated myocardial infarction (MI); (5) mild valvular disease; and (6) no symptoms and <3 cardiovascular risk factors. These patients can be safely encouraged to initiate or resume sexual activity or to receive treatment for sexual dysfunction. An important exception is the use of sildenafil in patients taking nitrates in any form. Patients in the intermediate-risk category include those with (1) moderate angina; (2) a recent MI (<6 weeks); (3) left ventricular dysfunction and/or class II congestive heart failure; (4) nonsustained low-risk arrhythmias; and (5) >/=3 risk factors for coronary artery disease. These patients should receive further cardiologic evaluation before restratification into the low- or high-risk category. Finally, patients in the high-risk category include those with (1) unstable or refractory angina; (2) uncontrolled hypertension; (3) congestive heart failure (class III or IV); (4) very recent MI (<2 weeks); (5) high-risk arrhythmias; (6) obstructive cardiomyopathies; and (7) moderate-to-severe valvular disease. These patients should be stabilized by specific treatment for their cardiac condition before resuming sexual activity or being treated for sexual dysfunction. A simple algorithm is provided for guiding physicians in the management of sexual dysfunction in patients with varying degrees of cardiac risk.

Adult↗

Management of sexual dysfunction in patients with cardiovascular disease: recommendations of The Princeton Consensus Panel.

Sexual dysfunction is highly prevalent in both sexes and adversely affects patients' quality of life and well being. Given the frequent association between sexual dysfunction and cardiovascular disease, in addition to the potential cardiac risk of sexual activity itself, a consensus panel was convened to develop recommendations for clinical management of sexual dysfunction in patients with cardiovascular disease. Based upon a review of the research and presentations by invited experts, a classification system was developed for stratification of patients into high, low, and intermediate categories of cardiac risk. The large majority of patients are in the low-risk category, which includes patients with (1) controlled hypertension; (2) mild, stable angina; (3) successful coronary revascularization; (4) a history of uncomplicated myocardial infarction (MI); (5) mild valvular disease; and (6) no symptoms and <3 cardiovascular risk factors. These patients can be safely encouraged to initiate or resume sexual activity or to receive treatment for sexual dysfunction. An important exception is the use of sildenafil in patients taking nitrates in any form. Patients in the intermediate-risk category include those with (1) moderate angina; (2) a recent MI (<6 weeks); (3) left ventricular dysfunction and/or class II congestive heart failure; (4) nonsustained low-risk arrhythmias; and (5) >/=3 risk factors for coronary artery disease. These patients should receive further cardiologic evaluation before restratification into the low- or high-risk category. Finally, patients in the high-risk category include those with (1) unstable or refractory angina; (2) uncontrolled hypertension; (3) congestive heart failure (class III or IV); (4) very recent MI (<2 weeks); (5) high-risk arrhythmias; (6) obstructive cardiomyopathies; and (7) moderate-to-severe valvular disease. These patients should be stabilized by specific treatment for their cardiac condition before resuming sexual activity or being treated for sexual dysfunction. A simple algorithm is provided for guiding physicians in the management of sexual dysfunction in patients with varying degrees of cardiac risk.

Humans↗

A simplified lesion classification for predicting success and complications of coronary angioplasty. Registry Committee of the Society for Cardiac Angiography and Intervention.

In 1988, the American College of Cardiology/American Heart Association (ACC/AHA) Task Force on Assessment of Diagnostic and Therapeutic Cardiovascular Procedures presented a classification of coronary lesions utilizing 26 lesion features to predict the success and complications of balloon angioplasty. Using data from the Registry of the Society for Cardiac Angiography and Interventions (SCAI) we evaluated the ability of this classification to predict success and complications. Lesion success, death in hospital, emergency cardiac bypass surgery, and major adverse events were evaluated in 41,071 patients who underwent single-vessel angioplasty from January 1993 to June 1996. Logistic models using the ACC/AHA lesion classification, vessel patency, or both, were compared. A new classification based on the interaction of the ACC/AHA classification plus lesion patency was compared with the existing ACC/AHA classification. Vessel patency, added to the ACC/AHA classification, improved prediction of lesion success (p </=0.0001). Class A and patent B lesions had similar success and complication rates, so a simplified classification (SCAI) using only 7 lesion characteristics could be created. This system (I: non-C patent, II: C patent, III: non-C occluded, and IV: C occluded) improved prediction of lesion success compared with the ACC/AHA classification (Bayesian Information Criterion statistic: ACC/AHA 16539, SCAI 15956; and area under the receiver- operating characteristics curve 0.659, 0.693, respectively). The SCAI classification was preferred for predicting major complications and in-hospital death and was similar to the ACC/AHA classification for predicting emergency bypass surgery.

Aged↗

Effects of insoluble and soluble dietary fiber on glycemic control in dogs with naturally occurring insulin-dependent diabetes mellitus.

OBJECTIVE: To evaluate the effects of diets differing in type and quantity of fiber on glycemic control in dogs with naturally occurring insulin-dependent diabetes mellitus. DESIGN: Prospective randomized crossover controlled trial. ANIMALS: 7 dogs with well-regulated naturally occurring insulin-dependent diabetes mellitus. PROCEDURE: Dogs were fed 1 of 3 diets for 1 month each in 1 of 6 randomized diet sequences. Diets included a low-fiber diet (LF) and 2 high-fiber diets; 1 contained only insoluble fiber (HIF), and 1 contained soluble fiber in addition to insoluble fiber (HSF). Caloric intake was unchanged throughout the study. Glycemic control was assessed after each feeding trial by measuring serum fructosamine concentration and performing 5 serial measurements of blood glucose concentration every 2 hours after the morning feeding and insulin injection. RESULTS: Significant differences were not detected in body weight, required insulin dosage, or albumin concentration among dogs fed the HIF, HSF, and LF diets. Mean and maximum blood glucose concentrations and area under the blood glucose curve were significantly lower in dogs fed the HIF diet, compared with values in the same dogs fed the HSF or LF diet. Fructosamine concentration was significantly lower in dogs fed the HIF or HSF diet, compared with values in the same dogs fed the LF diet. CONCLUSIONS AND CLINICAL RELEVANCE: In dogs with naturally occurring insulin-dependent diabetes mellitus, a dry, high insoluble-fiber diet may aid in glycemic control.

Animals↗

Efficacy and safety of catheter ablation in octogenarians.

OBJECTIVES: To determine whether catheter ablation is safe and effective in patients over the age of 80. BACKGROUND: There is a tendency to withhold invasive therapy in the elderly until it has been proven safe and effective. METHODS: Over a two-year period from February 1, 1996 to February 1, 1998, 695 consecutive patients underwent 744 catheter ablation procedures of supraventricular and ventricular arrhythmias. These patients were divided into three groups based on age: > or =80 years, 60 to 79 years and <60 years. Acute ablation success, using standard criteria and complication rates for these three groups were determined. RESULTS: There were 37 patients > or =80 years, 275 patients 60 to 79 years and 383 patients <60 years old. The overall acute ablation success rate for the entire group was 95% with no difference in rates among the three groups (97%, > or =80 years; 94%, 60-79 years; 95%, <60 years). The percentage of patients undergoing His bundle ablation was greatest in the > or =80-year-old group (43% vs. 19% vs. 2%, p < 0.01), and the percentage of patients undergoing accessory pathway ablation was greatest in the <60-year-old patients (0% vs. 4% vs. 25%, p < 0.01). The overall complication rate for the entire group was 2.6%, and there was only one major/life-threatening complication. There was no difference in complication rates among the groups (0%, > or =80 years; 2.2%, 60 to 79 years; 3.1%, <60 years). Based on the sample size, the 95% confidence interval is 0% to 7.8% for an adverse event in the octogenarian. CONCLUSIONS: Catheter ablative therapy for the arrhythmias attempted in the very elderly appears to be effective with low risk. Ablation results appear to be comparable with those noted in younger patients.

Aged↗

Detailed examination of fenfluramine-phentermine users with valve abnormalities identified in Fargo, North Dakota.

Although several studies have reported on valve abnormalities among users of fenfluramine or dexfenfluramine, detailed information on these subjects has not been provided, limiting the ability to understand who may be at risk for valve abnormalities and to generate hypotheses about the etiology and pathogenesis of these abnormalities. This study was a detailed medical record review of 18 previously reported users of fenfluramine and phentermine, all with valve abnormalities on echocardiogram and 2 with surgical pathology. Both clinical characteristics and medication use were recorded by trained abstracters using a standardized data collection form. Two subjects (11%) had other possible etiologies of valve disease: a history of rheumatic fever and prescribed ergotamine. Three subjects (17%) had a history of migraine headaches and 4 (22%) had murmurs noted before using fenfluramine. Use of medications that may affect serotonin receptors was common: ergotamine (1 subject, 5%), selective serotonin reuptake inhibitors (6, 33%), sumatriptan (2, 11%), and mirtazapine (1, 5%). Prior medication and nonmedication allergies were recorded in 6 (33%) and 3 (17%) subjects, respectively. All subjects had symptoms possibly due to fenfluramine or phentermine side effects. This study raises the hypotheses that valvular heart disease among fenfluramine users may be less common than previously estimated, that serotonin excess may play a role in valve pathology, and that a patient's response to anorexigens and other medications may serve as a marker for increased risk. Further study is needed to test these hypotheses.

Adult↗

Controlled trials in bipolar I depression: focus on switch rates and efficacy.

Until recently, the rate at which patients switch from bipolar depression to the manic or hypomanic phase of the disorder during treatment with antidepressant medications was poorly defined. The completion of three large-scale, double-blind controlled trials in bipolar I depression has improved understanding of this phenomenon. The low switching rates observed in these studies of lamotrigine, paroxetine and moclobemide may indicate a special application of these drugs in the management of patients prone to antidepressant-induced switching. These studies also confirm prior suggestions that tricyclic antidepressants present the highest risk of switching. At present there is no consensus over the optimal definition of switching. Standardising the definition may lead to improvements in the clinical management of bipolar disorder.

Antidepressive Agents↗

Helicopter transfer offers a potential benefit to patients with acute stroke.

BACKGROUND AND PURPOSE: Rapid transport of patients to specialized centers is widely used in the management of myocardial infarction, trauma, and more recently, acute stroke. We evaluated the role of helicopter transportation as it relates to the availability of acute stroke therapies and patients' perceptions of care. METHODS: We reviewed records of all patients transferred to a university hospital within 24 hours of stroke onset from January 1996 to December 1997. Data were collected on demographics, neurological deficit, treatment, and outcome. In addition, a questionnaire was sent to all patients with items about perceived reasons for helicopter transfer, expected and actual treatment, outcome, and overall impression. RESULTS: Helicopter transfer was used for 73 stroke patients. Before transfer, 8 patients (11%) received tissue plasminogen activator (tPA). On arrival, no patient received tPA, 38 patients (52%) were enrolled in acute stroke studies, and 35 patients (48%) received no specific medication. All but 2 patients were managed in a specialized stroke unit. Of the 35 patients who received no specific therapy, 24 (69%) were ineligible for treatment or study enrollment owing to 1 or more exclusion criteria, but rarely (3%) because of time. Of the 45 respondents to the survey, most (84%) were transferred at the suggestion of the physician at the originating hospital because of a possible treatment that was unavailable there. Most patients (93%) believed that there was a benefit from emergent helicopter transfer to a stroke center, although 40% of respondents received no specific therapy. CONCLUSION: Interhospital transfer by air may benefit a substantial number of acute stroke patients by offering potential therapies and intensive management not available elsewhere.

Air Ambulances↗

Risk factors for clinically important adverse events after protamine administration following cardiopulmonary bypass.

OBJECTIVES: The purpose of this study was to determine risk factors for adverse events following protamine administration after cardiopulmonary bypass. BACKGROUND: Intravenous protamine administration is associated with a risk of severe systemic reactions. However, risk factors for these events have not been well delineated, thus hampering development of preventive strategies. METHODS: A case-control study nested within a cohort of consecutive patients undergoing surgery requiring cardiopulmonary bypass was performed. The primary case definition included those events (pulmonary hypertensive and systemic hypotensive) occurring within 10 min of protamine administration in the absence of other measurable causes of hemodynamic compromise. RESULTS: Comparing the 53 cases to the 223 control subjects, three risk factors were independently associated with events (multivariable odds ratio [95% confidence interval]): neutral protamine Hagedorn insulin use (8.18 [2.08, 32.2]); fish allergy (24.5 [1.24, 482.3]), and a history of nonprotamine medication allergy (2.97 [1.25, 7.07]). These risk factors demonstrated an increasingly strong association with progressively more specific case definitions. An estimated 39% of cardiopulmonary bypass patients had one or more of these risk factors. Prior intravenous protamine, central venous pressure prior to protamine, preoperative ejection fraction and the need for inotropes when coming off bypass did not exhibit statistically significant associations with events (all p > 0.15). Prior protamine allergy was associated specifically with an increased risk of pulmonary hypertension (multivariable odds ratio 189; 95% confidence interval 13, 2,856). CONCLUSIONS: Immunologic factors are important in predisposing individuals to protamine reactions, and a substantial proportion of patients are at considerably increased risk Strategies to reduce the risk of protamine-associated events are needed.

Cardiopulmonary Bypass↗

Adverse events after protamine administration in patients undergoing cardiopulmonary bypass: risks and predictors of under-reporting.

A retrospective cohort study of patients undergoing cardiopulmonary bypass over 2 years at a single hospital was performed to determine the rate and predictors of attributing events to protamine and reporting them to a well-developed, hospital-based adverse drug reaction (ADR) program. Overall, 123 (12.9%) of 952 procedures were associated with an adverse event. Thirteen percent of these events were attributed to protamine in the medical record and 2.4% were reported to the ADR program. Only 19% of events attributed to protamine were reported. Even after excluding events with other measurable etiologies, the incidence of adverse events (2.6%) was still higher than that of attributed (0.8%) or reported (0.3%) events. Events that manifest as pulmonary hypertension occurred sooner after protamine, or were severe were significantly more likely to be attributed to protamine. These predictors demonstrated similar relationships with the probability of reporting events. Reliance on reporting of adverse events could not only underestimate the risk of these events, but might bias studies by identifying non-representative events.

Adverse Drug Reaction Reporting Systems↗

Clinical studies on the use of lamotrigine in bipolar disorder.

New mood stabilizers that possess efficacy in the depressed phase of bipolar disorder are needed. The use of marketed antidepressants puts bipolar patients at some increased risk for drug-induced hypomania/mania and rapid cycling. During the development of the antiepileptic, lamotrigine, the drug was observed to improve mood, alertness, and social interactions in some patients with epilepsy. These early observations provided the rationale for investigations into lamotrigine's potential efficacy in bipolar disorder. There are now 14 open clinical reports involving a total of 207 lamotrigine-treated patients with bipolar disorder that suggest this drug possesses a broad spectrum of efficacy in the management of the depressed, hypomanic, manic, and mixed phases of bipolar disorder. In an attempt to replicate and extend these preliminary open-label prospective findings, a series of multicenter, double-blind, placebo-controlled studies evaluating the efficacy and dose-response relationships of lamotrigine in the various phases of the illness, including both acute and maintenance designs in both bipolar I and II disorder, is ongoing.

Anticonvulsants↗

Lack of hepatotoxic effects of parenteral ketorolac in the hospital setting.

BACKGROUND: No large controlled studies to date have examined the hepatic safety of parenteral ketorolac, which is used to treat acutely ill hospitalized patients who may be at greatest risk of liver injury. OBJECTIVE: To measure the association between the use of parenteral ketorolac and subsequent liver injury. METHODS: A nonexperimental cohort study conducted in 35 hospitals in the greater Philadelphia, Pa, region examined 10,272 courses of parenteral ketorolac (the exposed group) and 10,247 courses of parenteral opioid (the comparison group). Liver injury was defined by a modified international consensus definition that relied exclusively on liver function tests. Proportional hazards regression was used to calculate the rate ratio and 95% confidence interval for the association between ketorolac exposure and the occurrence of liver injury, controlling for potentially confounding factors, and to explore the possible effects of duration and dose. RESULTS: The incidence of liver injury was 1.0% in the ketorolac group and 1.2% in the opioid group, yielding an unadjusted rate ratio of 0.77 (95% confidence interval, 0.59 1.01). Simultaneously adjusting for multiple potentially confounding factors did not change this result. There was no evidence for a duration-response relationship (P = .96) or a dose-response relationship (P = .23). We were unable to identify any subgroups that were susceptible to possible hepatotoxic effects of parenteral ketorolac. CONCLUSIONS: This study failed to find evidence of a hepatotoxic effect of parenteral ketorolac use in the hospital setting and provides strong evidence against the existence of a clinically meaningful association between exposure to parenteral ketorolac in the hospital setting and liver injury.

Analgesics, Non-Narcotic↗

Parenteral ketorolac: the risk for acute renal failure.

BACKGROUND: Acute renal failure has been associated with parenteral ketorolac tromethamine, but the risk that is associated with this therapy has not been quantified. OBJECTIVE: To compare the risk for acute renal failure associated with ketorolac with that associated with opioids. DESIGN: Retrospective cohort study. SETTING: 35 hospitals in or near Philadelphia. PATIENTS: Patients receiving 10,219 courses of parenteral ketorolac and patients receiving 10,145 courses of parenteral opioids. MEASUREMENTS: Acute renal failure was defined by 1) an increase in the serum creatinine concentration of 50% or more and 2) either an absolute increase of 44.2 mumol/L or more for concentrations that were less than 132.6 mumol/L at baseline or an absolute increase of 88.4 mumol/L or more for concentrations that were 132.6 mumol/L or more at baseline. In addition, a secondary definition required a diagnosis by a physician. RESULTS: The overall incidence of acute renal failure was 1.1% after therapy with either ketorolac or opioids. Multivariate-adjusted rate ratios comparing ketorolac with opioids for acute renal failure were 1.09 (95% CI, 0.83 to 1.42) overall, 1.00 (CI, 0.76 to 1.33) for less than 5 days of therapy, and 2.08 (CI, 1.08 to 4.00; P = 0.03) for more than 5 days of therapy. Similar results were obtained when the secondary definition of acute renal failure was used. CONCLUSIONS: Overall, acute renal failure was uncommon in this hospitalized population. Compared with opioids, ketorolac administered for 5 days or less did not increase the rate of renal failure. However, among patients who were treated with analgesics for more than 5 days, ketorolac may be associated with an elevated rate of acute renal failure.

Acute Kidney Injury↗

Risk of major complications from coronary angioplasty performed immediately after diagnostic coronary angiography: results from the Registry of the Society for Cardiac Angiography and Interventions.

OBJECTIVES: This study was designed to determine the risk of performing percutaneous transluminal coronary angioplasty (PTCA) at the time of diagnostic catheterization ("combined procedures"). BACKGROUND: Health care providers are under increasing pressure to combine diagnostic and interventional coronary procedures to reduce costs. However, the risk associated with combined procedures has not been rigorously assessed. METHODS: A multicenter cohort study of 35,700 patients undergoing elective PTCA from 1992 through 1995 was performed to determine the risk of major complications (myocardial infarction, emergency coronary artery bypass graft surgery or death) from combined relative to staged procedures (i.e., performing PTCA at a session subsequent to diagnostic catheterization). RESULTS: The risks of major complications from combined and staged procedures were 2.0% and 1.6%, respectively (unadjusted odds ratio [OR] 1.28, 95% confidence interval [CI] 1.05 to 1.57). After adjusting for clinical and angiographic differences and clustering by laboratory, the risk from combined procedures was not significantly elevated (multivariable OR 1.18, 95% CI 0.89 to 1.55). However, several subgroups of patients did have an increased risk from combined procedures: patients with multivessel disease (multivariable OR 1.64, 95% CI 1.13 to 2.39); women (multivariable OR 1.64, 95% CI 1.05 to 2.55); patients > 65 years old (multivariable OR 1.40, 5% CI 1.02 to 1.93); and patients undergoing multilesion PTCA (multivariable OR 1.53, 95% CI 1.06 to 2.21). The risk of combined relative to staged procedures decreased over the 4-year period (multivariable p = 0.029). CONCLUSIONS: Combining PTCA with diagnostic catheterization appears to be safe in many patients. However, several subgroups of patients may be at increased risk. Careful patient selection will most likely remain critical to ensuring the safety of combined procedures.

Aged↗

Calcium channel blockers and hypertension: 1. New trials.

The long-term benefits and risks of using calcium channel blockers to treat hypertension have been called into question by reports of increased incidence of myocardial infarction and death among patients taking these drugs. There is now a worldwide effort, involving more than 30 countries and 100,000 patients, to provide a comprehensive data-base for making informed decisions.

Calcium Channel Blockers↗