Biomedical subjects

R Holubkov

Publications and source records attributed to R Holubkov.

At least 37 records · Page 2Linked to original sources

PubMed1999

Trends in coronary revascularization 1989 to 1997: the Bypass Angioplasty Revascularization Investigation (BARI) survey of procedures.

Use of catheter-based and surgical coronary revascularization has steadily increased in North America. Introduction of catheter-based "new devices," including intracoronary stents, has expanded the range of patients who can be treated with percutaneous approaches. We sought to address trends in the practice of catheter-based and surgical coronary revascularization during 1989 to 1997. The 17 North American institutions participating in the NHLBI Bypass Angioplasty Revascularization Investigation (BARI) periodically completed a 5-working day survey of all surgical and catheter-based coronary revascularizations. Data collected included patient demographics, vessel disease, prior interventions, and use of new devices or minimally invasive surgical techniques. The proportion of all procedures that were catheter based (vs surgical) increased from 52.1% in 1989/1990 to 62.0% in 1997 (p <0.001). Among surgically treated patients, prevalence of prior bypass surgery decreased from 13.4% in 1989/1990 to 7.5% in 1997 (p <0.001). In 1997, 3% of surgical procedures used minimal incisions or were performed without cardiopulmonary bypass. Among patients undergoing catheter-based intervention, prevalence of left main disease increased from 2.2% to 5.7% (p <0.001), myocardial infarction within 24 hours increased from 2.4% to 9.7% (p <0.001), and prior bypass surgery increased from 16.2% to 20.8% (p = 0.056). Use of new devices increased from 11.6% of catheter-based procedures in 1990 to 67.0% in 1997 (p <0.001). Compared with the early 1990s, catheter-based revascularization is currently more commonly used for patients with acute myocardial infarction, prior bypass surgery, or severe left main narrowing. These trends are likely due to the proliferation of new devices, especially intracoronary stents, since the mid 1990s.

Angioplasty↗

PubMed1999

Coronary revascularization in diabetic patients: a comparison of the randomized and observational components of the Aypass Angioplasty Revascularization Investigation (BARI).

BACKGROUND: Patients with treated diabetes in the randomized-trial segment of the Bypass Angioplasty Revascularization Investigation (BARI) who were randomized to initial revascularization with PTCA had significantly worse 5-year survival than patients assigned to CABG. This treatment difference was not seen among diabetic patients eligible for BARI who opted to select their mode of revascularization. We hypothesized that differences in patient characteristics, assessed and unmeasured, together with the treatment selection in the registry, at least partially account for this discrepancy. METHODS AND RESULTS: Among diabetics taking insulin or oral hypoglycemic drugs at entry, angiographic and clinical presentations were comparable between randomized and registry patients. However, more registry patients were white, and registry diabetics tended to be more educated and more physically active and to report better quality of life. Procedural characteristics and in-hospital complications were comparable. The 5-year all-cause mortality rate was 34.5% in randomized diabetic patients assigned to PTCA versus 19.4% in CABG patients (P=0.0024; relative risk [RR]=1.87); corresponding cardiac mortality rates were 23.4% and 8.2%, respectively (P=0.0002; RR=3.10). The CABG benefit was more apparent among patients requiring insulin. In the registry, all-cause mortality was 14.4% for PTCA versus 14.9% for CABG (P=0.86, RR=1.10), with corresponding cardiac mortality rates of 7.5% and 6. 0%, respectively (P=0.73; RR=1.07). These RRs in the registry increased to 1.29 and 1.41, respectively, after adjustment for all known differences between treatment groups. CONCLUSIONS: BARI registry results are not inconsistent with the finding in the randomized trial that initial CABG is associated with better long-term survival than PTCA in treated diabetic patients with multivessel coronary disease suitable for either surgical or catheter-based revascularization.

Aged↗

PubMed1999

Coronary flow velocity response to adenosine characterizes coronary microvascular function in women with chest pain and no obstructive coronary disease. Results from the pilot phase of the Women's Ischemia Syndrome Evaluation (WISE) study.

OBJECTIVES: We sought to develop and validate a definition of coronary microvascular dysfunction in women with chest pain and no significant epicardial obstruction based on adenosine-induced changes in coronary flow velocity (i.e., coronary velocity reserve). BACKGROUND: Chest pain is frequently not caused by fixed obstructive coronary artery disease (CAD) of large vessels in women. Coronary microvascular dysfunction is an alternative mechanism of chest pain that is more prevalent in women and is associated with attenuated coronary volumetric flow augmentation in response to hyperemic stimuli (i.e., abnormal coronary flow reserve). However, traditional assessment of coronary volumetric flow reserve is time-consuming and not uniformly available. METHODS: As part of the Women's Ischemia Syndrome Evaluation (WISE) study, 48 women with chest pain and normal coronary arteries or minimal coronary luminal irregularities (mean stenosis = 7%) underwent assessment of coronary blood flow reserve and coronary flow velocity reserve. Blood flow responses to intracoronary adenosine were measured using intracoronary Doppler ultrasonography and quantitative angiography. RESULTS: Coronary volumetric flow reserve correlated with coronary velocity reserve (Pearson correlation = 0.87, p < 0.001). In 29 (60%) women with abnormal coronary microcirculation (mean coronary flow reserve = 1.84), adenosine increased coronary velocity by 89% (p < 0.001) but did not change coronary cross-sectional area. In 19 (40%) women with normal microcirculation (mean flow reserve = 3.24), adenosine increased coronary velocity and area by 179% (p < 0.001) and 17% (p < 0.001), respectively. A coronary velocity reserve threshold of 2.24 provided the best balance between sensitivity and specificity (90% and 89%, respectively) for the diagnosis of microvascular dysfunction. In addition, failure of the epicardial coronary to dilate at least 9% was found to be a sensitive (79%) and specific (79%) surrogate marker of microvascular dysfunction. CONCLUSIONS: Coronary flow velocity response to intracoronary adenosine characterizes coronary microvascular function in women with chest pain in the absence of obstructive CAD. Attenuated epicardial coronary dilation response to adenosine may be a surrogate marker of microvascular dysfunction in women with chest pain and no obstructive CAD.

Adenosine↗

PubMed1999

Dobutamine stress echocardiography in women with chest pain. Pilot phase data from the National Heart, Lung and Blood Institute Women's Ischemia Syndrome Evaluation (WISE).

OBJECTIVES: The aim of this project was to assess the utility of dobutamine stress echocardiography (DSE) for evaluation of women with suspected ischemic heart disease. BACKGROUND: Most investigations addressing efficacy of diagnosis and treatment of coronary artery disease (CAD) have been performed in predominantly male populations. As part of the Women's Ischemia Syndrome Evaluation (WISE) study, DSE was assessed in women participating at the University of Florida clinical site. METHODS: Women with chest pain or other symptoms suggestive of myocardial ischemia and clinically indicated coronary angiography were eligible for the WISE study. Enrolled subjects underwent DSE using a modified protocol. Coronary stenosis was assessed by core laboratory quantitative coronary angiography (QCA). RESULTS: The 92 women studied ranged in age from 34 to 82 years (mean 57.5). All women had > or = 1 major risk for CAD, and most (89, 97%) had > or = 2 risk factors. In 78 women (85%), left ventricular wall motion was normal at baseline and during peak infusion. The remaining 14 women had wall motion abnormalities during DSE. By QCA, 25 women (27%) had > or = 50% coronary stenosis, including 10 with single-vessel obstruction. Dobutamine stress echocardiography was abnormal in 10 of these 25 women, yielding overall sensitivity of 40%, and 60% for multivessel stenosis. Exclusion of women with inadequate heart rate response yielded overall sensitivity of 50%, and 81.8% for multivessel stenosis. Dobutamine stress echocardiography was normal in 54 of the 67 women with < 50% coronary narrowing, specificity 80.6%. CONCLUSIONS: Dobutamine stress echocardiography reliably detects multivessel stenosis in women with suspected CAD. However, DSE is usually negative in women with single-vessel stenosis, and in the larger subset without coronary stenosis. Ongoing protocols of the WISE study are expected to improve diagnostic accuracy in women with single-vessel disease, as well as provide important data in the substantial number of women with chest pain but without epicardial coronary artery stenosis.

Adult↗

PubMed1999

Intravenous immune globulin in the therapy of peripartum cardiomyopathy.

OBJECTIVES: We sought to evaluate the effect of therapy with intravenous immune globulin on recovery of left ventricular function in women presenting with peripartum cardiomyopathy. BACKGROUND: Peripartum cardiomyopathy is a rare complication of pregnancy that results in significant morbidity and mortality in women of childbearing age. Intravenous immune globulin has been reported to improve left ventricular systolic function in patients with acute dilated cardiomyopathy and myocarditis, but its effectiveness in peripartum cardiomyopathy is unknown. METHODS: In this retrospective study, we compared the clinical outcomes of six women with peripartum cardiomyopathy treated with intravenous immune globulin (2 g/kg) with those of 11 recent historical control subjects. All women in the study were referred between 1991 and 1998 with class II to IV heart failure and a left ventricular ejection fraction of <0.40. Left ventricular ejection was reassessed during early follow-up (6.1+/-2.9 months). RESULTS: The two groups did not differ in terms of baseline left ventricular ejection fraction, left ventricular end-diastolic diameter, months to presentation, age or multiparity. The improvement in left ventricular ejection fraction in patients treated with immune globulin was significantly greater than in the conventionally treated group (increase of 26+/-8 ejection fraction units vs. 13+/-13, p = 0.042). CONCLUSIONS: In this small retrospective study of women with peripartum cardiomyopathy, patients treated with immune globulin had a greater improvement in ejection fraction during early follow-up than patients treated conventionally. Given the poor prognosis of women with peripartum cardiomyopathy who do not improve, this therapy merits further study.

Adolescent↗

PubMed1999

Effect of inotrope withdrawal on morbidity and mortality in patients with chronic heart failure: results of the vesnarinone trial withdrawal substudy. Vest Withdrawal Substudy Group.

BACKGROUND: The use of inotropic agents in the therapy of patients with congestive heart failure (CHF) is controversial. One concern regarding inotropic therapy has been that drug withdrawal could be associated with a worsening of symptoms. METHODS AND RESULTS: We took advantage of the discontinuation of the recent trial of vesnarinone in the therapy of CHF to assess the effects of withdrawal of the inotropic agent, vesnarinone, in patients with chronic CHF who had been randomized to receive either placebo or 30 or 60 mg of vesnarinone. Contrary to our initial hypothesis, withdrawal of vesnarinone did not impact on either morbidity or mortality over a period of 6 months. CONCLUSION: Although these results suggest vesnarinone withdrawal is safe, the applicability of these results to other inotropic agents remains unclear.

Cardiotonic Agents↗

PubMed1999

Measurement of hemostatic indexes in conjunction with transcranial doppler sonography in patients with ventricular assist devices.

BACKGROUND AND PURPOSE: Clinical thromboembolism (TE) remains an impediment to the chronic application of ventricular assist devices (VADs). Microembolic signals (MES) have been detected by transcranial Doppler ultrasound (TCD) in patients with VADs, although their origin and relation to TE remain undefined. We have investigated the hypothesis that hemostatic alterations are related to MES and that MES are associated with TE in a group of 27 VAD patients. METHODS: Indexes of coagulation, fibrinolysis, and cellular activation and aggregation were measured before and during the VAD implantation period in conjunction with TCD. Groups were defined on the basis of presence of MES, degree of MES showering, and incidence of TE. RESULTS: MES were observed in 67 (58%) of 115 of individual postoperative TCD measurements and in 21 (78%) of 27 patients. Of patients with TE, 10 (83%) of 12 had detectable MES compared with 11 (73%) of 15 patients without TE (P=0.66). MES were significantly associated with elevated thrombin generation during the implantation period, as reflected by plasma prothrombin fragment F1.2. Elevations in indexes of coagulation, platelet activation, and fibrinolysis relative to normal control subjects were found for patients with VADs with and without detected MES. CONCLUSIONS: Although no significant relation between MES and TE in VAD patients was found, the data support the hypothesis that MES are related to increased hemostatic activity in this patient group despite aggressive anticoagulant therapy.

Adolescent↗

PubMed1999

Artificial Valve Endocarditis Reduction Trial (AVERT): protocol of a multicenter randomized trial.

BACKGROUND AND AIM OF THE STUDY: This article presents the protocol of the Artificial Valve Endocarditis Reduction Trial (AVERT), a multicenter, international randomized trial to assess the efficacy of the SilzoneTM coating of St. Jude Medical Masters Series mechanical heart valves in the prevention of prosthetic heart valve endocarditis (PVE). A total of 4,400 eligible patients will be randomized within three years of study commencement at 17 participating clinical centers in North America and Europe, with study completion within four years. ELIGIBILITY CRITERIA: Eligible patients are candidates for St. Jude mechanical valves with either the Silzone or conventional cuff, in the mitral and/or aortic position, who give informed written consent to participate. Major exclusion criteria are the presence of prosthetic valves that do not require replacement, and the need for tricuspid valve replacement. Bypass surgery and valve repair are allowed during the implant operation. Patients will be randomized using an envelope-based intraoperative randomization scheme, stratified by clinical center and by the presence of endocarditis at the time of surgery. FOLLOW UP: Patients will be contacted at discharge, three months, and each anniversary of the implant procedure. A brief follow up survey, administered via clinic interview, telephone or mail, will elicit events associated with possible endocarditis (unexplained fever, worsening angina, hospitalization) that will initiate contact with the patient's following physician. OUTCOME ANALYSIS: The primary PVE endpoint will be based upon a published algorithm, with two infectious disease specialists making the final determination of cases classified as possible endocarditis. Study data will be periodically reviewed by a Data Safety Monitoring Board. The primary analysis will be an intention-to-treat comparison of freedom from PVE curves between the Silzone and conventional cuff treatment groups. CONCLUSIONS: AVERT will provide much-needed information on the effectiveness of Silzone in preventing PVE, as well as practice patterns and outcomes of valve replacement.

Clinical Protocols↗

PubMed1998

One-year follow-up of the Stent Restenosis (STRESS I) Study.

We present the completed 1-year follow-up results of the original Stent Restenosis Study (STRESS I), in which 407 patients with symptomatic ischemic heart disease and new lesions of the native coronary circulation were randomly assigned to treatment with either the Palmaz-Schatz coronary stent or conventional percutaneous transluminal coronary angioplasty (PTCA). The present study compares the safety of elective stenting to balloon angioplasty (PTCA) in terms of freedom from clinical events up to 1 year after treatment. Patients were enrolled and treated from January 1991 through February 1993, and follow-up data were collected and verified until July 1995. Ninety-seven percent of all patients had complete follow-up (deceased or alive with known clinical status) beyond 8 months, and 94% beyond 11 months. Anginal status between 9 to 15 months postprocedure was available for 78% of patients. At 1 year, 154 patients (75%) assigned to stent implantation and 141 (70%) to PTCA were free of all clinical events (death, myocardial infarction, or any revascularization procedure), and 162 stent patients (79%) and 149 PTCA patients (74%) were free from death, myocardial infarction, or target lesion revascularization. Symptom-driven target lesion revascularization occurred in 12% of the stent group versus 17% of the PTCA group. None of these differences in clinical events was statistically significant. Only 2 patients in the stent group and 7 in the PTCA group had a first event after 239 days, and freedom from angina at 1 year was reported in equal frequency in both groups (84%). There appear to be no late adverse effects of stent implantation. However, these results are limited by low statistical power, narrow patient selection, and the anticoagulation regimen used in the early experience with this device.

Angioplasty, Balloon, Coronary↗

PubMed1998

Balloon angioplasty versus new device intervention: clinical outcomes. A comparison of the NHLBI PTCA and NACI registries.

OBJECTIVES: We sought to compare outcomes of patients treated in the National Heart, Lung, and Blood Institute (NHLBI) Percutaneous Transluminal Coronary Angioplasty (PTCA) and New Approaches to Coronary Intervention (NACI) registries. BACKGROUND: Coronary angioplasty has numerous shortcomings. New devices for performing coronary interventions have been introduced in an effort to improve clinical outcomes. METHODS: Under the sponsorship of the NHLBI, a registry of consecutive patients treated with PTCA during 1985 to 1986 was established. In 1990, the NHLBI funded a second registry, the NACI. The two registries used the same data coordinating center to collect detailed baseline and follow-up information. RESULTS: Patients enrolled in the NACI registry were older, had undergone more previous bypass surgery procedures and had more stenoses located in bypass grafts than patients in the NHLBI PTCA registry. Procedural success was achieved in 72.1% and 82.6% of patients in the PTCA and NACI registries, respectively; however, in-hospital and 1-year mortality rates were 1.0% versus 1.8% and 3.1% versus 5.9% for the PTCA versus NACI registries, respectively. After risk adjustment, there was no difference in 1-year mortality. Rates of target lesion revascularization (TLR) were 21.5% for the PTCA registry and 24.2% for the NACI registry. NACI registry patients had a higher risk for TLR and the composite end point of death, myocardial infarction or revascularization (relative risk 1.28 and 1.23, respectively). However, the NACI registry patients who received stents tended to have a lower adjusted TLR rate. CONCLUSIONS: This comparative study found no overall superiority of these newer devices in terms of patient survival or freedom from TLR after adjustment for baseline risk profiles. Although technologic improvements (especially improved stenting) continue, these observations highlight the importance of careful assessment of clinical results in the broad population of patients in whom interventions are used.

Angioplasty, Balloon, Coronary↗

PubMed1998

Unstable angina: specialty-related disparities in implementation of practice guidelines.

BACKGROUND: The agency for Health Care Policy and Research (AHCPR) has published practice guidelines to improve the quality of care patients with unstable angina. Prior to publication, studies demonstrated that when compared with cardiologists, internists were less likely to use effective pharmacologic therapies or revascularization in patients with unstable angina. HYPOTHESIS: The study was undertaken to determine whether the AHCPR guideline publication abolished specialty-related disparities in care. METHODS: We performed a chart review of consecutive patients hospitalized at a university-affiliated institution with an admission diagnosis of chest pain in the absence of myocardial infarction and a noncardiac etiology. Treatment and diagnostic cardiac testing were compared between risk-stratified patients cared for by a generalist (n = 125) and those whose care was guided by a cardiologist (n = 211). RESULTS: In those with low-risk unstable angina, generalists were less likely to prescribe recommended aspirin (71 vs. 88%, p < 0.01) and beta blockers (9 vs. 37%, p < 0.001), and heparin (20 vs. 49%, p < 0.001), and to perform a recommended diagnostic stress test or cardiac catheterization (28 vs. 60%, p < 0.001). In those with at least intermediate risk, generalists were less likely to prescribe beta blockers (19 vs. 52%, p < 0.001), heparin (19 vs. 66%, p < 0.001), and nitrates (77 vs. 96%, p < 0.001), and to refer for diagnostic testing (19 vs. 65%, p < 0.001). Generalists' care was associated with significantly lower hospital charges. CONCLUSIONS: AHCPR guidelines for the evaluation and treatment of unstable angina are implemented more effectively, but not uniformly, by cardiologists at our institution. Further studies are necessary to evaluate the barriers to implementation of the AHCPR guidelines.

Aged↗

PubMed1998

Preoperative risk models for minimally invasive coronary bypass: a preliminary study.

OBJECTIVE: Available risk assessment models are designed for standard coronary artery bypass grafting. We hypothesized that minimally invasive coronary bypass could improve on predicted outcome in extremely high-risk patients (Parsonnet score > 20%) by the current risk models. METHODS: From September 1996 to September 1997, 27 consecutive extremely high-risk patients underwent minimally invasive coronary bypass. Seventeen patients were male; age was 73 +/- 12 years, and 63% of patients were older than 75 years. Left ventricular ejection fraction was 33.7% +/- 15% and 63% had an ejection fraction of less than 35%. The predicted 30-day mortality according to the System 97 model was 25.6% +/- 11.3%. The Parsonnet risk score was 36.2% +/- 11%; the predicted length of stay in the hospital was 15.3 +/- 3 days. The predicted risk of stroke according to the Multicenter Perioperative Stroke Risk Index was 22.3% +/- 11.7%. RESULTS: Minimally invasive coronary bypass was isolated in 20 patients and integrated with angioplasty and stenting in 7 patients. The observed 30-day mortality was 0% (P < .01 vs predicted): at an average follow-up of 10.8 +/- 4.1 months, 26 patients (96.3%) are alive without angina; one patient with acquired immunodeficiency syndrome died on postoperative day 40 of acute pancreatitis. No patient had a stroke or neurologic deficit (P < .01 vs predicted). Patency of internal thoracic artery anastomosis was confirmed by angiography in all 27 patients. No patient required reoperation. Eighteen patients (67%) were extubated in the operating room. The observed length of hospital stay after minimally invasive coronary bypass was 3.8 +/- 2.6 days (P < .01 vs predicted). CONCLUSION: On the basis of our results on a relatively small series of patients, we suggest that risk models geared for standard coronary bypass grafting may not be appropriate for minimally invasive coronary bypass.

Aged↗

PubMed1998

MIDCAB characteristics and results: the CardioThoracic Systems (CTS) registry.

OBJECTIVE: The CardioThoracic Systems (CTS) registry of minimally invasive direct coronary artery bypass (MIDCAB) was established to examine baseline characteristics of patients undergoing this surgical procedure, document details of the procedures including grafting techniques and post-operative complication rates, and assess post-operative graft patency. METHODS: A total of 508 consecutive patients who had MIDCAB using CTS instrumentation between April 1996 and March 1997 at 35 international centers were analyzed. RESULTS: The mean age of patients, 27% of whom were women, was 63 years. Eight percent had previous coronary artery bypass surgery. While nearly all patients had significant stenoses in the left anterior descending artery, 23% had disease in two vessels and 9% in three vessels. Almost all procedures used the left internal mammary artery, with 7% employing multiple or sequential grafts. The entire surgical procedure lasted on average 135 min (median 2 h), with a mean time of 14 min to perform anastomosis. Surgical approaches, including anastomosis technique and method used to maintain bloodless field, varied widely across clinical centers. In-hospital complication rates were relatively low, with 0.6% mortality (0% perioperative), 1.2% conversion to sternotomy with cardiopulmonary bypass, 1.4% conversion to sternotomy without bypass, and 5.5% redo or reintervention. In total, 92% of patients were free from all of these events at hospital discharge; women showed a strong trend toward increased risk for major in-hospital events compared with men. Rib fracture was the most common complication, reported in 12% of patients. Post-operative angiography, performed in 83 patients at an average 2.2 days post-procedure, found full patency in 78 (94%). CONCLUSIONS: The CTS registry data indicates that in the great majority of patients, MIDCAB using CTS instrumentation was performed safely and with acute success. Comparative studies, most importantly clinical trials, are needed to determine the types of patients who benefit most from this procedure, as well as its longer-term outcome.

Coronary Artery Bypass↗

PubMed1998

Long-term outcome of patients with incomplete vs complete revascularization after multivessel PTCA. A report from the NHLBI PTCA Registry.

BACKGROUND: Incomplete revascularization is frequently the goal as well as the final outcome in patients with multivessel coronary disease undergoing PTCA. However, the long-term impact of incomplete revascularization is not known and this common PTCA strategy deserves further scrutiny. METHODS AND RESULTS: Complete revascularization was achieved in 132 of 757 patients with multivessel disease in the 1985-86 NHLBI PTCA Registry. Compared to patients in whom complete revascularization was achieved, patients with incomplete revascularization were older (P < 0.05), more likely to be females (P < 0.05) and to have recent myocardial infarction (P < 0.05), unstable angina (P < 0.001), and urgent or emergent PTCA (P < 0.001). Early death, Q wave myocardial infarction and CABG rates were higher in patients with incomplete than in those with complete revascularization [significantly different (P < 0.05) only for emergency and elective CABG]. At 9 years, nearly twice as many patients with incomplete revascularization experienced recurrent angina (19% vs 10% for patients with complete revascularization, P < 0.05). Patients with complete revascularization were more likely to undergo repeat PTCA than those with incomplete revascularization (40% vs 30%, P < 0.05). Patients with incomplete revascularization were more likely to undergo CABG than patients with complete revascularization (32% vs 14%, P < 0.001; adjusted risk 2.56, 95% CI 1.60, 4.10). Among patients with incomplete revascularization, those in whom PTCA was intended but not attempted had the highest early event rates and late CABG rates. Finally, the adjusted risk of dying, having a Q wave myocardial infarction, recurrent angina or repeat PTCA was not different at 9-year follow-up among patients with and without complete revascularization. CONCLUSIONS: Complete revascularization achieved by PTCA reduces late occurrence of CABG, but not adjusted rates of death, Q wave myocardial infarction, recurrent angina, and repeat PTCA in patients with multivessel coronary disease. These data tend to support the PTCA strategy of incomplete revascularization in patients with multivessel disease when complete revascularization is not feasible or not planned before the procedure.

Adult↗

PubMed1998

Estrogen acutely abolishes abnormal cold-induced coronary constriction in men.

BACKGROUND AND STUDY OBJECTIVE: Ambient cold exposure may induce myocardial ischemia by precipitating coronary artery constriction and a decrease in coronary blood flow. Estrogen has vasoactive properties that may prevent abnormal coronary constriction in a sex-independent manner. The purpose of this study is to determine whether estrogen acutely abolishes abnormal coronary responses to cold exposure in men. DESIGN: Randomized, double-blinded placebo-controlled clinical trial. SETTING: Cardiac catheterization laboratory. PATIENTS: Men referred for routine diagnostic coronary angiography who exhibit abnormal coronary artery constriction in response to a 90-s cold pressor test (CPT). INTERVENTION: Intravenous conjugated estrogens (1.25 mg) vs. placebo. MEASUREMENTS AND RESULTS: Rate-pressure product, coronary cross-sectional area (CSA), and coronary blood flow responses to the CPT were measured before and 15 min after intervention. In 12 men with CPT-induced coronary constriction who were assigned to estrogen, CPT induced a mean 21.8% decrease in coronary CSA (p < 0.01) and a nonsignificant change in coronary flow. After estrogen, the repeated CPT induced a 16.3% increase in CSA (p < 0.01) and a 54.9% increase in flow (p < 0.01). CSA and coronary flow responses to CPT were significantly different before and after estrogen (p < 0.01). In contrast, placebo was not associated with changes in CSA or coronary flow responses to CPT in eight men. CONCLUSIONS: In men, conjugated estrogens acutely abolish abnormal coronary constriction and improve coronary blood flow responses to an exogenous cold stimulus. These results suggest that estrogen favorably alters coronary vasoreactivity in men.

Aged↗

PubMed1998

Analysis, assessment, and presentation of risk-adjusted statewide obstetrical care data: the StORQS II study in Washington State. Statewide Obstetrics Review and Quality System.

OBJECTIVE: To develop an effective, concise presentation of hospital-specific birth event and delivery-related complication rates, including significant deviations from expected rates calculated using risk-adjusted peer hospital data, for distribution to all Washington State hospitals with delivery services. DATA SOURCES: Complete data for calendar year 1993, including inpatient discharge records for mothers and newborns, birth certificates, and infant death records, for 74 hospitals from Washington state source files. STUDY DESIGN: Institutions were classified into four peer groups based on presence of neonatal intensive care units, number of births, and rural/urban location. Twenty-three clinical indicators of procedure (e.g., cesarean section) and complication rates were analyzed and presented. METHODS: For each indicator, observed and expected rates (adjusted within peer group for categorized baseline risk factors) were calculated and presented by institution. Effective graphic and numeric techniques for presenting significant deviations from expected rates were developed. Results were calculated in terms of numbers of events as well as rates. Approaches applicable to institutions with small numbers of deliveries were selected. PRINCIPAL FINDINGS: Exact confidence intervals (C.I.s) for event rates were superior to binomial or Poisson approximations for small hospitals. For calculating expected rates, indirect adjustment was used due to small numbers within risk factor categories. For all indicators, observed and expected rates along with 95 percent C.I.s for the true rate were presented graphically by institution for each peer group. Transforming C.I.s into "statistically acceptable ranges" allowed hospital personnel to assess their performance in terms of actual numbers of events as well as rates. CONCLUSIONS: Readily available statistical methods and straightforward descriptive approaches allow accurate presentation of outcomes for both large and small institutions.

Adult↗

PubMed1997

Treatment of patients admitted to the hospital with congestive heart failure: specialty-related disparities in practice patterns and outcomes.

OBJECTIVES: This study sought to define specialty-related differences in the care and outcome of patients admitted to the hospital with congestive heart failure (CHF). BACKGROUND: Congestive heart failure is the leading diagnosis-related group (DRG) discharge diagnosis in the United States and accounts for an estimated annual hospital cost in excess of $7 billion. The clinical impact of aggressive CHF management and the importance of the subspecialist in guiding this care have not been evaluated. METHODS: To define differences in physician practice patterns, we performed a chart review of consecutive patients admitted to a university teaching hospital with a primary DRG discharge diagnosis of CHF. We compared treatment and outcome of patients cared for by a generalist (n = 160) and those whose care was guided by a cardiologist (n = 138) during their index hospital period with CHF and over the next 6 months. RESULTS: At our institution, > 50% of patients admitted to the hospital with CHF cared for by generalists alone had minimal (New York Heart Association functional class I or II) symptoms, compared with < 15% of those cared for by a cardiologist (p < 0.01). Although generalists' patients underwent significantly fewer in-hospital diagnostic tests and had shorter lengths of stay, they had a 1.7-fold increased risk of readmission for CHF within 6 months (p < 0.05). Six-month cardiac and all-cause mortality were not significantly different between the groups. The type of physician caring for the patient and a history of diabetes, previous CHF or myocardial infarction were independent predictors of readmission for CHF. CONCLUSIONS: Involvement of a cardiologist in the care of patients admitted to the hospital with CHF is associated with increased use of diagnostic testing, longer hospital stays and improved clinical outcome. These results substantiate practice guidelines that suggest a role for cardiologists in the care of symptomatic patients with CHF.

Aged↗

PubMed1997

Vapocoolant spray is equally effective as EMLA cream in reducing immunization pain in school-aged children.

BACKGROUND: Untreated immunization pain causes undue distress and contributes to underimmunization through physician, and possibly parental, resistance to multiple simultaneous injections. OBJECTIVE: To compare the efficacies of two pain management methods in reducing immediate immunization injection pain and distress in school-aged children. DESIGN: A randomized, controlled clinical trial of eutectic mixture of local anesthetics (EMLA) cream and vapocoolant spray. PATIENTS: Children aged 4 to 6 years and scheduled to receive diphtheria and tetanus toxoids and acellular pertussis vaccine (DTaP) during health supervision visits. INTERVENTIONS: Enrolled children were randomized to one of three treatment groups: 1) EMLA cream + distraction; 2) vapocoolant spray + distraction; or 3) distraction alone (control). The specific pharmacologic pain control interventions consisted of EMLA cream (2.5% lidocaine, 2.5% prilocaine [Astra Pharmaceutical Products, Inc, Westborough, MA] $15. 00/patient; applied 60 minutes before injection) and vapocoolant spray (Fluori-Methane [Gebauer Company, Cleveland, OH] $0. 50/patient; applied via spray-saturated cotton ball for 15 seconds immediately before injection). MAIN OUTCOME MEASURES: The blinded investigator (BI) measured (by edited videotape) cry duration and the number of pain behaviors using the Observational Scale of Behavioral Distress. Pain visual analog scales (linear and faces scales) were completed by the child, parent, nurse, and the BI. RESULTS: Sixty-two children, aged 4.5 +/- 0.4 years (mean +/- SD) were randomized. The three treatment groups had similar subject characteristics. All pain measures and cry duration were similar for EMLA and vapocoolant spray. Both EMLA and spray were significantly better than control. Results for spray vs control: cry duration (seconds): 8.5 +/- 21.0 vs 38.6 +/- 50.5; number of pain behaviors: 1.2 +/- 1.9 vs. 3.1 +/- 2.1; child-scored faces scale: 2.0 +/- 2.4 vs. 4.1 +/- 2.3; parent-scored faces scale: 1.6 +/- 1.6 vs. 3.0 +/- 1.7; nurse-scored faces scale: 1.6 +/- 1.2 vs. 3.1 +/- 1.4; and BI-scored faces scale: 1.0 +/- 1.5 vs. 2.4 +/- 1.4. CONCLUSIONS: When combined with distraction, vapocoolant spray significantly reduces immediate injection pain compared with distraction alone, and is equally effective as, less expensive, and faster-acting than EMLA cream. As an effective, inexpensive, and convenient pain control method, vapocoolant spray may help overcome physician and parent resistance to multiple injections that leads to missed opportunities to immunize.

Age Factors↗