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ABSTRACT: Context
Randomized clinical trials (RCTs) evaluating the pulmonary artery catheter
(PAC) have been limited by small sample size. Some nonrandomized studies suggest
that PAC use is associated with increased morbidity and mortality.Objective
To estimate the impact of the PAC device in critically ill patients.Data Sources
MEDLINE (1985-2005), the Cochrane Controlled Trials Registry (1988-2005),
the National Institutes of Health ClinicalTrials.gov database, and the US
Food and Drug Administration Web site for RCTs in which patients were randomly
assigned to PAC or no PAC were searched. Results from the ESCAPE trial of
patients with severe heart failure were also included. Search terms included pulmonary artery catheter, right heart
catheter, catheter, and Swan-Ganz.Study Selection
Eligible studies included patients who were undergoing surgery, in the
intensive care unit (ICU), admitted with advanced heart failure, or diagnosed
with acute respiratory distress syndrome and/or sepsis; and studies that reported
death and the number of days hospitalized or the number of days in the ICU
as outcome measures.Data Extraction
Information on eligibility criteria, baseline characteristics, interventions,
outcomes, and methodological quality was extracted by 2 reviewers. Disagreements
were resolved by consensus.Data Synthesis
In 13 RCTs, 5051 patients were randomized. Hemodynamic goals and treatment
strategies varied among trials. A random-effects model was used to estimate
the odds ratios (ORs) for death, number of days hospitalized, and use of inotropes
and intravenous vasodilators. The combined OR for mortality was 1.04 (95%
confidence interval [CI], 0.90-1.20; P = .59).
The difference in the mean number of days hospitalized for PAC minus the mean
for no PAC was 0.11 (95% CI, −0.51 to 0.74; P = .73).
Use of the PAC was associated with a higher use of inotropes (OR, 1.58; 95%
CI, 1.19-2.12; P = .002) and intravenous
vasodilators (OR, 2.35; 95% CI, 1.75-3.15; P<.001).Conclusions
In critically ill patients, use of the PAC neither increased overall
mortality or days in hospital nor conferred benefit. Despite almost 20 years
of RCTs, a clear strategy leading to improved survival with the PAC has not
been devised. The neutrality of the PAC for clinical outcomes may result from
the absence of effective evidence-based treatments to use in combination with
PAC information across the spectrum of critically ill patients.
Figures in this Article
The pulmonary artery catheter (PAC) is used to diagnose various diseases
and physiological states, monitor the progress of critically ill patients,
and guide the selection and adjustment of medical therapy.1 The
PAC is often considered a cornerstone of critical care and a hallmark of the
intensive care unit (ICU).2 Approximately 1
million PACs are used annually in the United States.3 However,
despite widespread use of these devices, there are conflicting data about
their utility. The majority of nonrandomized studies in critically ill patients
have suggested that the PAC is associated with increased morbidity and mortality.4 Conversely, some nonrandomized studies have shown
improved quality of life when the PAC was used to direct a specific therapeutic
approach.5- 7
Since the mid-1980s, randomized clinical trials (RCTs) have been conducted
to evaluate the efficacy of the PAC. However, none of these trials have been
persuasive individually, because they are limited by small sample sizes in
heterogeneous populations. Ivanov et al performed 2 meta-analyses on PAC use
through 1996.8- 9 One study focused
on mortality from 16 RCTs of the PAC8 and the
other focused on major morbidity from 12 RCTs9;
however, neither study restricted the randomization specifically to catheter
vs no catheter use. There was no difference found in mortality, but there
was a statistically significant difference in major morbidity, which was defined
separately for each organ system.8- 9
Despite the overwhelmingly negative tenor of the literature, clinicians
continue to use the PAC in ICUs based on personal experience and the belief
that careful monitoring will improve decision making and clinical outcomes.
To provide a broad perspective for the recently completed ESCAPE trial,10 in which patients with advanced heart failure were
randomized to the PAC or clinical assessment alone, we performed a meta-analysis
of 13 recently published clinical trials testing the safety and efficacy of
the PAC.
JAMA The Journal of the American Medical Association 294(13):1664-1670. · 30.03 Impact Factor
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Adrian F. Hernandez,
Eric J. Velazquez,
Scott D. Solomon,
Rakhi Kilaru,
Rafael Diaz,
Christopher M. O’Connor,
George Ertl,
Aldo P. Maggioni,
Jean-Lucien Rouleau,
Wiek van Gilst,
Marc A. Pfeffer, Robert M. Califf
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ABSTRACT: Background
How often echocardiography and cardiac catheterization are used to evaluate left ventricular (LV) function in patients with myocardial infarction (MI) and how they are associated with quality of care is unknown.Methods
Patients with MI in the Valsartan in Acute Myocardial Infarction (VALIANT) registry were divided into those with (n = 1423) and without (n = 3968) heart failure (HF), and the use of either echocardiography or cardiac catheterization for LV assessment in each group was compared along with associated baseline characteristics. We evaluated the association between LV assessment and discharge medications. Using a multivariable model with a propensity analysis, we evaluated the association of LV assessment with in-hospital outcomes.Results
Of the patients with HF, 322 (22.6%) had no LV assessment. Patients with HF with LV assessment were discharged more frequently under treatment with aspirin (81.3% vs 70.0%; P<.001), β-blockers (65.6% vs 56.4%; P = .008), clopidogrel (30.4% vs 14.0%; P<.001), and statins (45.9% vs 34.2%; P<.001). Patients without HF who underwent LV assessment were discharged more frequently under treatment with an angiotensin-converting enzyme inhibitor (53.8% vs 41.5%; P<.001). After adjustment for regional use, other covariates, and revascularization, LV assessment was associated with lower in-hospital mortality in patients with HF (adjusted odds ratio [OR], 0.45; P<.001) and in patients without HF (adjusted OR, 0.30; P<.001). After excluding deaths during the first 2 days, LV assessment remained associated with lower mortality in patients with HF (adjusted OR, 0.59; P = .03) and in patients without HF (adjusted OR, 0.41; P<.001).Conclusion
Left ventricular assessment was frequently not performed during the in-hospital stay of patients with acute MI, including those with clinical HF, and its use was associated with better quality of care.
Figures in this Article
Current guidelines from professional organizations emphasize early identification and treatment of patients with acute myocardial infarction (MI) or acute coronary syndromes with high-risk features.1- 3 Among the most important predictors of 30-day mortality in patients with MI is evidence of either heart failure (HF) by Killip classification or left ventricular (LV) systolic dysfunction.4- 6 Thus, evidence of HF or LV systolic dysfunction can influence the choice of therapy.7 In addition, as state and federal efforts to measure quality and publicly report outcomes expand, professional organizations have developed performance measures of quality of care. One such measure is LV assessment in patients with HF who have a clinical event.8- 10 For patients with MI who develop complications such as HF or evidence of LV systolic dysfunction, current guidelines recommend further evaluation, yet it is not known how often echocardiography or cardiac catheterization is used to evaluate hospitalized patients with MI, including those complicated by HF.1- 3
Numerous studies have evaluated the use of cardiac catheterization in MI, but little is known about the association of LV assessment by either echocardiography or cardiac catheterization with benchmarks of quality care.11- 14 In high-risk patients with MI, such as those with HF, diagnostic testing has been recommended to guide revascularization and/or medical therapy.1- 2 Cardiac catheterization plays a pivotal role in evaluation, but many hospitals do not have invasive cardiovascular facilities, and entire regions have limited access to this technology. Therefore, noninvasive risk stratification often guides the intensity of care and helps determine the need and urgency of triage for invasive procedures. However, the use of noninvasive diagnostic testing such as echocardiography in the acute MI setting has not been well described.
Using data collected from patients with MI enrolled in the registry associated with the Valsartan in Acute Myocardial Infarction (VALIANT) trial, we examined the frequency of LV assessment by echocardiography or cardiac catheterization, its association with quality of care such as guideline-recommended therapies, and outcomes.15- 16
Archives of Internal Medicine 165(18):2162-2169. · 11.46 Impact Factor
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ABSTRACT: Objectives. We sought to determine whether the results of the first Coronary Angioplasty Versus Excisional Atherectomy Trial (CAVEAT-I) influenced subsequent practice patterns among the investigators.Background. CAVEAT-I demonstrated that directional coronary atherectomy (DCA) resulted in higher rates of early complications at a higher cost and with no clinical benefit. We sought to determine whether these results influenced subsequent use of procedures among CAVEAT-I investigators.Methods. We compared the results of a week-long registry of all coronary interventions performed at 35 CAVEAT-I sites in 1994 with those of a similar registry obtained in 1992 before the trial, the results of which were published in 1993. For control purposes, the use of procedures was studied at 24 additional sites to provide insight into practice at hospitals not participating in the trial. A total of 1,465 interventions were analyzed.Results. Ninety-four percent of CAVEAT-I sites responded. Utilization rates differed between CAVEAT-I and CAVEAT-I follow-up (p < 0.001). Balloon angioplasty decreased from 83.8% to 68.5%, DCA increased slightly from 10.7% to 14.1%, and the use of other devices increased from 5.4% to 17.5%. Stand-alone balloon use was more prevalent at nonparticipating control sites than at sites that took part in CAVEAT-I (p < 0.001).Conclusions. Paradoxically, despite the negative findings of CAVEAT-I, there was a noteworthy trend toward an increase in the use of DCA and other devices at CAVEAT-I sites. Our findings suggest that among investigators in the trial, there may have been a lack of influence of trial data on clinical practice patterns 1 year after publication of the results. Ethics of protocol: Both CAVEAT I and II were approved by the Institutional Review Board at each study site.
Journal of the American College of Cardiology.
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ABSTRACT: Objectives. We sought to study the relation between recurrent ST segment shift within 6 to 24 h of initial resolution of ST elevation after thrombolytic therapy and 30-day and 1-year mortality.Background. Rapid and stable resolution of ST segment elevation in relation to thrombolytic therapy in patients with an acute myocardial infarction is an indicator of culprit artery patency. Whether recurrence of ST segment shift during continuous ST monitoring after initial resolution is related to poor prognosis has not been studied.Methods. ST segment monitoring was performed within 30 min after thrombolytic therapy for acute myocardial infarction. The predictive value of a new ST segment shift (assessed as ≥0.1-mV deviation from the baseline) 6 to 24 h after thrombolytic therapy was studied with respect to 30-day and 1-year mortality.Results. Of 734 patients, 243 had a new ST segment shift (33%). The 30-day mortality rate in patients with an ST shift (7.8%) was significantly higher than that in patients without an ST shift (2.25%, p = 0.001), as was the 1-year mortality rate (10.3% vs. 5.7%, respectively, p = 0.025). Multivariable analysis revealed an independent predictive value of ST shift with respect to 30-day mortality (p = 0.008), even after consideration of multiple clinical risk factors in the overall Global Utilization of Streptokinase and TPA for Occluded Coronary Arteries (GUSTO)-I mortality model (p = 0.0001). Moreover, the duration of the ST shift bore a direct relation with 1-year mortality (p = 0.008).Conclusions. Detection of ST segment shift early after thrombolytic therapy for acute myocardial infarction is a simple, noninvasive means of identifying patients at high risk and is superior to other commonly assessed clinical risk factors. Thus, patients with a new ST shift after the first 6 h, but within 24 h, represent a high risk group that may benefit from more aggressive intervention, whereas patients without evidence of an ST shift represent a low risk subgroup.
Journal of the American College of Cardiology.
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ABSTRACT: Objectives. We sought to assess the effects of antithrombotic therapy after thrombolysis for acute myocardial infarction on markers of thrombin generation and activity and to determine the relation of these markers with clinical outcomes.Background. Thrombin activation and generation often occur with thrombolysis for acute myocardial infarction. Antithrombotic regimens have been developed to reduce the resulting thrombotic complications.Methods. We sampled plasma markers of thrombin generation and activity after thrombolysis in 292 patients. We assessed the relations of these markers with clinical outcomes at 30 days.Results. Fibrinopeptide A (FPA), a marker of thrombin activity toward fibrinogen, was elevated at baseline (12.3 ng/ml) and increased to 18.4 ng/ml by 90 min after streptokinase and subcutaneous heparin treatment. With intravenous heparin, this increase was attenuated, but intravenous heparin did not prevent thrombin generation, as measured by prothrombin fragment 1.2 (F1.2). Heparin level, measured by anti-Xa activity, correlated with activated partial thromboplastin time (aPTT, r = 0.62 to 0.67). Thrombin activity, measured by FPA, was as closely related to aPTT as to the heparin level. Baseline levels of F1.2 were significantly related to the risk of death or reinfarction at 30 days (p = 0.008); values 12 h after enrollment also were related to 30-day mortality (p = 0.05).Conclusions. Although intravenous heparin partly suppresses the increased thrombin activity associated with thrombolysis, it does not inhibit thrombin generation. The aPTT was as good a measure of suppression of thrombin activity as the heparin level itself. Hematologic markers of thrombin generation were found to be related to the subsequent risk of thrombotic events.
Journal of the American College of Cardiology.
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Jeffrey S. Mandak,
James C. Blankenship,
Laura H. Gardner,
Scott D. Berkowitz,
Frank V. Aguirre,
Kristina N. Sigmon,
Gerald C. Timmis,
Ian C. Gilchrist,
Michael McIvor,
Jon Resar,
Bonnie H. Weiner,
Barry S. George,
J.David Talley,
A.Michael Lincoff,
James E. Tcheng, Robert M. Califf,
Eric J. Topol
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ABSTRACT: Objectives. This study was designed to identify potential predictors of vascular access site (VAS) complications in the large-scale Integrilin to Minimize Platelet Aggregation and Coronary Thrombosis (IMPACT) II trial, which studied angioplasty with versus without a new glycoprotein (GP) IIb/IIIa receptor inhibitor (eptifibatide).Background. GP IIb/IIIa receptor inhibition during coronary interventions has been associated with excess VAS complications. If other predictors of VAS complications could be identified, they might be manipulated to reduce complications.Methods. A total of 4,010 patients undergoing percutaneous transluminal coronary revascularization (PTCR) were randomized into one of three bolus/20- to 24-h infusion arms: placebo bolus/placebo infusion; 135-μg/kg body weight eptifibatide bolus/0.5-μg/kg per min eptifibatide infusion; or 135-μg/kg eptifibatide bolus/0.75-μg/kg per min eptifibatide infusion. Heparin during the procedure was weight adjusted and stopped 4 h before sheaths were removed. Logistic regression modeling was used to identify independent predictors of VAS complications.Results. VAS complications were more common in patients treated with eptifibatide (9.9% vs. 5.9% placebo-treated patients, p < 0.001). Multivariate analysis identified eptifibatide therapy (p < 0.0001), advanced age (p = 0.0001), longer time to sheath removal (p = 0.0002), stent placement (with intense post-stent anticoagulation) (p = 0.0004), female gender (p = 0.0006), PTCR within 24 h of thrombolytic therapy (p = 0.002), larger heparin doses during PTCR (p = 0.009), major coronary dissection (p = 0.03) and placement of a venous sheath (p = 0.04) as independent predictors of VAS complications.Conclusions. VAS complications may be reduced by early sheath removal, by avoiding placement of venous sheaths and by limiting heparin dosing to avoid excessive activated clotting times. Early sheath removal during inhibition of platelet aggregation by eptifibatide is feasible.
Journal of the American College of Cardiology.
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ABSTRACT: Results of recent studies have suggested that routine cardiac catheterization may be unnecessary after reperfusion therapy for acute myocardial infarction. Therefore to better define the short-term prognostic value of early coronary angiography, and specifically the prognostic significance of multivessel coronary artery disease, the angiographic findings of 855 patients consecutively enrolled in five phases of the TAMI study were correlated with their in-hospital outcome. All patients received intravenous thrombolytic therapy (tissue plasminogen activator, urokinase, or both agents) and underwent cardiac catheterization within 90 minutes of the initiation of therapy. Multivessel disease, defined as the presence of >= 75% luminal diameter stenosis in two or more major epicardial arteries, was documented in 236 patients. When compared with the group of patients without multivessel disease, this group had a higher prevalence of coronary risk factors and more frequently had a history of antecedent ischemic chest pain. Although the severity of the infarct zone dysfunction was similar in the two groups (-2.77 +/- 1.00 vs -2.50 +/- 1.09 SD/chord, p = NS), global left ventricular ejection fraction was lower in the group with multivessel disease (48.6 +/- 12.4% vs 51.8 +/- 10.6%, p p = 0.0001). The in-hospital mortality rate, predominantly the result of myocardial failure and cardiogenic shock, was also significantly higher in the multivessel group (11.4% vs 4.2%, p p p = 0.01), TIMI grade infarct vessel flow (p = 0.03), and patient age (p = 0.03). According to this model the prognostic significance of one additional year of age was equivalent to a reduction in left ventricular function of 1.1 ejection fraction percentage points; one additional diseased vessel was equivalent to 15 additional years of age or a reduction in ejection fraction of 16 percentage points. These data suggest that more aggressive revascularization procedures should be considered in the early postinfarction period for patients with multivessel disease and noninfarct zone dysfunction. In the absence of reliable noninvasive techniques, coronary angiography remains the procedure of choice for identifying this high-risk subgroup. Peer Reviewed http://deepblue.lib.umich.edu/bitstream/2027.42/29410/1/0000484.pdf
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ABSTRACT: Reperfusion therapy has been clearly shown to decrease the early mortality after acute myocardial infarction, but the impact of this therapy on long-term survival has been less extensively evaluated. This study reports the extended follow-up of a large cohort of 810 patients treated with intravenous thrombolytic therapy combined, when considered necessary to maintain or augment infarct vessel patency, with mechanical reperfusion therapies. Each patient underwent coronary angiography within 2 hours of the initiation of the thrombolytic infusion. Coronary angioplasty was performed in 62% of the patients before hospital discharge and 21% underwent coronary artery bypass graft surgery. Follow-up was obtained in 96% to a mean of 18.8 months (range, 1.5 to 48 months). All-cause mortality over this period was 3.3%; 2.1% died from cardiac causes. Nonfatal reinfarction occurred in 5.1%. Although the low event rate limits the validity of statistical comparisons, the patients who survived the follow-up period tended to be younger (56 +/- 10 vs 65 +/- 7 years), to have better predischarge left ventricular function (left ventricular ejection fraction, 52 +/- 11 vs 46 +/- 13%) and to have a lower prevalence of multivessel coronary artery disease (45 vs 67%). This excellent long-term survival may, in part, reflect the exclusion of high-risk patients from enrollment in the Thrombolysis and Angioplasty in Myocardial Infarction (TAMI) studies. It may also be attributable, however, to the frequent use of combined thrombolysis and mechanical revascularization in this population. Peer Reviewed http://deepblue.lib.umich.edu/bitstream/2027.42/28381/1/0000150.pdf
