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Biomedical subjects

Lee A Fleisher

Publications and source records attributed to Lee A Fleisher.

At least 19 recordsLinked to original sources

ACC/AHA 2006 guideline update on perioperative cardiovascular evaluation for noncardiac surgery: focused update on perioperative beta-blocker therapy--a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Update the 2002 Guidelines on Perioperative Cardiovascular Evaluation for Noncardiac Surgery).

The American College of Cardiology/American Heart Association (ACC/AHA) Task Force on Practice Guidelines makes every effort to avoid any actual, potential, or perceived conflict of interest that might arise as a result of an industry relationship or personal interest of the writing committee. Specifically, all members of the writing committee, as well as peer reviewers of the document, were asked to provide disclosure statements of all such relationships that might be perceived as real or potential conflicts of interest. These statements are reviewed by the parent task force, reported orally to all members of the writing committee at each meeting, and updated and reviewed by the writing committee as changes occur. Please see Appendix 1 for author relationships with industry and Appendix 2 for peer reviewer relationships with industry. These guidelines attempt to define practices that meet the needs of most patients in most circumstances. These guideline recommendations reflect a consensus of expert opinion after a thorough review of the available, current scientific evidence and are intended to improve patient care. If these guidelines are used as the basis for regulatory/payer decisions, the ultimate goal is quality of care and serving the patient's best interests. The ultimate judgment regarding care of a particular patient must be made by the healthcare provider and patient in light of all the circumstances presented by that patient.

Adrenergic beta-Antagonists↗

Effect of postoperative epidural analgesia on morbidity and mortality after lung resection in Medicare patients.

STUDY OBJECTIVE: To perform an analysis of the Medicare claims database in patients undergoing lung resection to determine whether there is an association between postoperative epidural analgesia and mortality. DESIGN: Retrospective cohort (database) design. SETTING: University hospital. MEASUREMENTS: We examined a cohort of 3501 patients obtained from a 5% nationally random sample of 1997 to 2001 Medicare beneficiaries who underwent nonemergency segmental excision of the lung (International Classification of Diseases, 9th Revision, Clinical Modification codes 32.3 and 32.4). Patient data were divided into two groups depending on the presence or absence of billing for postoperative epidural analgesia (Current Procedural Terminology code 01996). The primary outcomes assessed were death at 7 and 30 days after the procedure. The rates of major morbidity (acute myocardial infarction, angina, cardiac dysrhythmias, heart failure, pneumonia, pulmonary edema, respiratory failure, deep venous thrombosis, pulmonary embolism, sepsis, acute renal failure, somnolence, acute cerebrovascular event, transient organic syndrome, and paralytic ileus) were also compared. Multivariate regression analysis incorporating race, gender, age, comorbidities, hospital size, hospital teaching status, and hospital technology status was performed to determine whether the presence of postoperative epidural analgesia had an independent effect on mortality or major morbidity. MAIN RESULTS: Multivariate regression analysis showed that the presence of epidural analgesia was associated with a significantly lower odds of death at 7 days (odds ratio, 0.39; 95% confidence interval, 0.19-0.80; P = 0.001) and 30 days (odds ratio, 0.53; 95% confidence interval, 0.35-0.78; P = 0.002) after surgery. There was no difference between the groups with regard to overall major morbidity. CONCLUSIONS: Postoperative epidural analgesia may contribute to lower odds of death after segmental excision of the lung, although the mechanism of such a benefit is not clear from our analysis.

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Correlation of postoperative epidural analgesia on morbidity and mortality after colectomy in Medicare patients.

STUDY OBJECTIVE: To examine, with a large database, the effect of postoperative epidural analgesia (vs systemic analgesia) on mortality after colectomy is unclear. DESIGN: Retrospective cohort (database) design. SETTING: Medicare beneficiaries undergoing elective colectomy. PATIENTS: We examined a cohort of 12817 patients obtained from a 5% nationally random sample of Medicare beneficiaries from 1997 to 2001 who underwent elective partial excision of the large intestine. INTERVENTIONS: Patients were divided into two groups depending on the presence or absence of billing for postoperative epidural analgesia (Current Procedural Terminology code 01996). MEASUREMENTS: The primary outcomes assessed were death at 7 and 30 days after the procedure. The rates of major morbidity were also compared. Multivariate regression analysis incorporating race, gender, age, comorbidities, hospital size, hospital teaching status, and hospital technology status was performed to determine whether the presence of postoperative epidural analgesia had an independent effect on mortality or major morbidity. MAIN RESULTS: Multivariate regression analysis revealed that there was no difference between the groups with regard to overall major morbidity; however, the presence of epidural analgesia was associated with a significantly lower odds of death at 7 days (odds ratio, 0.35; 95% confidence interval, 0.21-0.59; P < 0.0001) and 30 days (odds ratio, 0.54; 95% confidence interval, 0.42-0.70; P < 0.0001) after surgery. CONCLUSIONS: The presence of postoperative epidural analgesia may decrease the odds of death after elective colectomy; however, the mechanism of such a benefit is not clear from our analysis.

Aged↗

Perioperative myocardial ischemic injury in high-risk vascular surgery patients: incidence and clinical significance in a prospective clinical trial.

OBJECTIVE: The purpose of this study was to assess prospectively the incidence, health care resource utilization, and economic burden associated with perioperative myocardial ischemic injury (PMII) in high-risk patients undergoing noncardiac vascular surgery. METHODS: Two hundred thirty-six patients consented to participate in a pharmacoeconomic substudy as part of a randomized, multicenter clinical trial. Patients were assessed for myocardial ischemic injury by using clinical, biochemical, and electrocardiographic criteria. PMII was defined as fatal or nonfatal myocardial infarction, new or worsened congestive heart failure, or new arrhythmias. Resource utilization parameters were compared for patients with and without PMII. Patients underwent the following index procedures: open abdominal aortic aneurysm repair (n = 44), bypass for aortoiliac disease (n = 29), bypass for femoropopliteal disease (n = 62), bypass for femorotibial disease (n = 71), extra-anatomic bypass (n = 23), and miscellaneous (n = 7). Patients undergoing carotid endarterectomy or only endovascular interventions were excluded. The incremental cost of PMII was estimated by applying the average costs (adjusted to 2004 US dollars) of the hospital ward (dollar 700.00/d) or intensive care unit (dollar 2500.00/d) to the length of stay differences for patients with and without PMII. RESULTS: The overall mortality was 3.4% (8/236), and 7 of 8 deaths were related to PMII. PMII occurred in 42 (17.8%) of 236 patients: 22 myocardial infarctions, 11 congestive heart failures, and 12 new arrhythmias (3 patients had 2 PMII events). There was no evidence of differences in the incidence of PMII among the various index procedures. PMII was associated with a dramatic increase in resource utilization. The mean length of stay was 16.8 and 10.0 days for patients with and without PMII, respectively (P < .001). Intensive care unit care was required by 35 (83.3%) of 42 patients with and 121 (62.4%) of 194 patients without PMII (P < .009). The mean intensive care unit length of stay was 6.6 and 3.7 days for patients with and without PMII, respectively (P < .009). Ten (23.8%) of 42 patients with and 20 (10.3%) of 194 patients without PMII returned to the emergency department for care after discharge (P < .02). CONCLUSIONS: In modern vascular surgery practice, PMII remains common despite the availability of beta-blockers and other preventative strategies. PMII is associated with dramatic increases in resource utilization and cost. The increase in resource utilization associated with PMII resulted in an estimated incremental cost per patient of dollar 9980.00. If 250,000 high-risk open vascular operations are performed annually in the United States, the economic burden of PMII in these procedures alone approximates dollar 444 million. Strategies to decrease PMII incidence and severity should be evaluated in large-scale prospective trials.

Aged↗

Association between reduced heart rate variability and cognitive impairment in older disabled women in the community: Women's Health and Aging Study I.

OBJECTIVES: To examine the independent association between heart rate variability (HRV), a marker of cardiac autonomic function, and cognitive impairment. DESIGN: Cross-sectional analysis of baseline data from Women's Health and Aging Study I. SETTING: Urban community in Baltimore, Maryland. PARTICIPANTS: A subset of 311 physically disabled, community-dwelling women aged 65 and older whose HRV data were obtained. MEASUREMENTS: Reduced HRV was defined as the lowest quartile of each of several HRV measures exploring time and frequency domains and compared with the remaining three quartiles. Cognitive impairment was defined as a Mini-Mental State Examination score less than 24. Multiple logistic regression was used to model the independent relationship between reduced HRV and prevalent cognitive impairment. RESULTS: The age-, education-, and race-adjusted prevalence of cognitive impairment was higher in those with reduced HRV than in those with nonreduced HRV. After adjusting for relevant demographic and clinical characteristics, participants with reduced HRV were significantly more likely than those with nonreduced HRV to have cognitive impairment; these findings were consistent across different HRV indices. In particular, reduced high-frequency power, indicative of decreased parasympathetic activity, was associated with 6.7 times greater odds of cognitive impairment (95% confidence interval = 2.27-20.0). CONCLUSION: Cardiac autonomic dysfunction, particularly decreased parasympathetic activity, was independently associated with cognitive impairment in older disabled women in the community. This finding may improve understanding of the pathophysiological basis of cognitive impairment. The potential role of HRV as a cause or consequence of cognitive impairment needs to be elucidated in future studies.

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Efficacy of continuous local anesthetic infusion for postoperative pain after radical retropubic prostatectomy.

OBJECTIVES: To determine whether a subfascial continuous infusion of local anesthetic in patients undergoing radical retropubic prostatectomy would result in a reduction in postoperative opioid requirements and an improvement in pain scores. METHODS: This was a prospective, double-blind, placebo-controlled, randomized trial in patients undergoing elective radical retropubic prostatectomy. A small catheter was placed subfascially at the end of surgery and attached to an elastomeric pump that administered either 0.5% bupivacaine or normal saline into the wound at a rate of 2 mL/hr until discharge on postoperative day 3. The outcomes assessed included the dosage of hydromorphone used by a patient-controlled analgesic system, a visual analog scale (VAS) for pain at rest and with activity, a VAS of nausea, and length of hospital stay. RESULTS: A total of 100 patients were successfully randomized, with all patients completing the protocol. No differences were found between the groups with regard to VAS pain at rest, VAS pain with activity, intravenous or oral analgesic consumption, or VAS nausea scores. CONCLUSIONS: Continuous subfascial infusion of local anesthetic did not result in a postoperative reduction in opioid requirements or an improvement in pain scores in patients undergoing radical retropubic prostatectomy.

Anesthetics, Local↗

Efficacy of zoniporide, an Na/H exchange ion inhibitor, for reducing perioperative cardiovascular events in vascular surgery patients.

OBJECTIVES: To determine whether a novel Na+/H+ exchange ion inhibitor, zoniporide, is associated with reduced perioperative myocardial ischemic injury in high-risk surgery patients. DESIGN: Randomized double-blind placebo-controlled multidose trial. SETTING: Multicenter worldwide (105 centers) trial. PARTICIPANTS: Patients with known or multiple risk factors for coronary artery disease undergoing noncardiac vascular surgery. INTERVENTIONS: Four parallel groups received 1 of 3 doses of zoniporide or placebo, delivered as a 60-minute loading dose immediately before surgery, and followed by a continuous intravenous infusion for up to 7 days. MEASUREMENTS AND MAIN RESULTS: A total of 824 subjects were randomized into the study from 105 centers worldwide. Of these, 784 subjects received study drug infusion in the 3-mg/kg/d, 6-mg/kg/d, and 12-mg/kg/d groups and the placebo group, and 769 satisfied the criteria for the primary efficacy analysis population. This is 68% of the planned sample size of 1125 subjects. Anesthetic management and perioperative cardiac medications were at the discretion of the attending anesthesiologists, surgeons, and cardiologists. The proportion of subjects who experienced the composite endpoint event (death, myocardial infarction, congestive heart failure, arrhythmia) by postsurgical day 30 was 18.5% in the 12-mg/kg/d group, compared with 15.7% in the placebo group, resulting in a relative risk (RR) of 1.17% (95% confidence interval [CI], 0.80-1.72; p = NS) favoring placebo. The proportions in the lower 2 zoniporide dose groups were slightly lower than in the placebo group, although the sample size is inadequate to reach any firm conclusions. CONCLUSIONS: The results fail to demonstrate the efficacy of zoniporide in reducing the proportion of patients at high risk undergoing noncardiac vascular surgery who experience a composite cardiovascular endpoint, which led the corporate sponsor to stop enrollment early on the basis of a futility analysis of the chance of demonstrating efficacy with a larger sample size.

Adult↗

Intermittent cardiac troponin-I screening is an effective means of surveillance for a perioperative myocardial infarction.

OBJECTIVE: Several studies suggest that cardiac troponin-I (cTn-I) is a more sensitive indicator of cardiac injury compared with other biochemical markers of injury, but the strategy with the highest diagnostic yield (true positive and true negative) for perioperative surveillance is unknown. The authors undertook a prospective evaluation of the perioperative incidence of myocardial infarction (MI) and evaluated surveillance strategies for the diagnosis of MI. DESIGN: Prospective, cohort study. SETTING: Two university hospitals. PARTICIPANTS: Four hundred sixty-seven high-risk patients requiring noncardiac surgery. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: The diagnosis of myocardial injury was determined by cardiac protein markers combined with either postoperative changes on 12-lead electrocardiography or 1 of 3 clinical symptoms consistent with MI (chest pain, dyspnea, requirement for hemodynamic support). A receiver operating characteristic curve evaluating troponin in the diagnosis of MI revealed a value of 2.6 ng/mL as having the highest sensitivity and specificity. The sensitivity and specificity of cTn-I value > or =2.6 ng/mL, troponin > or =1.5 ng/mL, total creatine kinase (CK) > or =170 IU/L with MB > or =5%, and CK-MB > or =8 ng/mL were compared. Surveillance strategies were determined on a subset of patients (n = 257). The incidence of MI was 9.0% by cTn-I > or =2.6 ng/mL criteria, 19% by cTn-I > or =1.5 ng/mL, 13% by CK-MB mass, and 2.8% by CK-MB%. The specificity of cTn-I > or =2.6 ng/mL as an indicator of MI was 98%, and its positive predictive value (PPV) was 85%. Cardiac troponin-I > or =2.6 ng/mL had equal specificity but greater PPV than the cTn-I > or =1.5 ng/mL (specificity 98% and PPV 79%). If surveillance of cTn-I > or =2.6 ng/mL was used to detect MI, then the strategy with the highest diagnostic yield was surveillance on postoperative days 1, 2, and 3. CONCLUSIONS: Perioperative cardiac injury continues to occur frequently after noncardiac surgery, as detected by cTn-I. Serial monitoring of cardiac troponin-I on postoperative days 1, 2, and 3 provides the strategy with the highest diagnostic yield for surveillance of MI.

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