Initial Findings From the North American COVID-19 Myocardial Infarction Registry.

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic has impacted many aspects of ST-segment elevation myocardial infarction (STEMI) care, including timely access to primary percutaneous coronary intervention (PPCI). OBJECTIVES: The goal of the NACMI (North American COVID-19 and STEMI) registry is to describe demographic characteristics, management strategies, and outcomes of COVID-19 patients with STEMI. METHODS: A prospective, ongoing observational registry was created under the guidance of 3 cardiology societies. STEMI patients with confirmed COVID+ (group 1) or suspected (person under investigation [PUI]) (group 2) COVID-19 infection were included. A group of age- and sex-matched STEMI patients (matched to COVID+ patients in a 2:1 ratio) treated in the pre-COVID era (2015 to 2019) serves as the control group for comparison of treatment strategies and outcomes (group 3). The primary outcome was a composite of in-hospital death, stroke, recurrent myocardial infarction, or repeat unplanned revascularization. RESULTS: As of December 6, 2020, 1,185 patients were included in the NACMI registry (230 COVID+ patients, 495 PUIs, and 460 control patients). COVID+ patients were more likely to have minority ethnicity (Hispanic 23%, Black 24%) and had a higher prevalence of diabetes mellitus (46%) (all p < 0.001 relative to PUIs). COVID+ patients were more likely to present with cardiogenic shock (18%) but were less likely to receive invasive angiography (78%) (all p < 0.001 relative to control patients). Among COVID+ patients who received angiography, 71% received PPCI and 20% received medical therapy (both p < 0.001 relative to control patients). The primary outcome occurred in 36% of COVID+ patients, 13% of PUIs, and 5% of control patients (p < 0.001 relative to control patients). CONCLUSIONS: COVID+ patients with STEMI represent a high-risk group of patients with unique demographic and clinical characteristics. PPCI is feasible and remains the predominant reperfusion strategy, supporting current recommendations.

The Cardiovascular Quality Improvement and Care Innovation Consortium: Inception of a Multicenter Collaborative to Improve Cardiovascular Care.

Despite decades of improvement in the quality and outcomes of cardiovascular care, significant gaps remain. Existing quality improvement strategies are often limited in scope to specific clinical conditions and episodic care. Health services and outcomes research is essential to inform gaps in care but rarely results in the development and implementation of care delivery solutions. Although individual health systems are engaged in projects to improve the quality of care delivery, these efforts often lack a robust study design or implementation evaluation that can inform generalizability and further dissemination. Aligning the work of health care systems and health services and outcomes researchers could serve as a strategy to overcome persisting gaps in cardiovascular quality and outcomes. We describe the inception of the Cardiovascular Quality Improvement and Care Innovation Consortium that seeks to rapidly improve cardiovascular care by (1) developing, implementing, and evaluating multicenter quality improvement projects using innovative care designs; (2) serving as a resource for quality improvement and care innovation partners; and (3) establishing a presence within existing quality improvement and care innovation structures. Success of the collaborative will be defined by projects that result in changes to care delivery with demonstrable impacts on the quality and outcomes of care across multiple health systems. Furthermore, insights gained from implementation of these projects across sites in Cardiovascular Quality Improvement and Care Innovation Consortium will inform and promote broad dissemination for greater impact.

One-year results of the ICON (Ionic versus non-ionic Contrast to Obviate worsening Nephropathy after angioplasty in chronic renal failure patients) Study.

BACKGROUND: Long-term clinical outcomes after exposure to non-ionic iso-osmolar contrast medium (IOCM) or ionic low-osmolar CM (LOCM) in patients with chronic kidney disease (CKD) undergoing coronary angiography are unclear. METHODS: The ICON trial was a prospective, double-blinded, multicentre study that randomly assigned 146 patients with CKD undergoing coronary angiography with or without percutaneous coronary intervention to the non-ionic IOCM Iodixanol or the ionic LOCM Ioxaglate. We report the 1-year clinical outcomes. RESULTS: After randomization, baseline and procedural characteristics were well-matched between the two groups. At 1 year, three deaths (4.1%) occurred in the ioxaglate and nine deaths in the iodixanol group (13.6%, P = 0.07). The cardiac death rate at 1 year was 2.7% in the ioxaglate group and 9.1% in the iodixanol group (P = 0.07). There were no significant differences in the rates of myocardial infarction (1.4% vs. 1.5%; P = 1.00) and repeated revascularization (6.8% vs. 9.1%; P = 0.75). CONCLUSIONS: The use of ionic LOCM ioxaglate was associated with a numerically lower mortality at 1 year as compared to iodixanol in patients who underwent cardiac catheterization. Future studies evaluating long-term safety following exposure to different types of CM are warranted.

Achieving sustainable first door-to-balloon times of 90 minutes for regional transfer ST-segment elevation myocardial infarction.

OBJECTIVES: A network approach to transfer ST-segment elevation myocardial infarction (STEMI) patients can achieve durable first door-to-balloon times (1st D2B) for percutaneous coronary intervention (PCI) within 90 min. BACKGROUND: Nationally, a minority of STEMI patients from referral centers obtain 1st D2B in <2 h and even fewer in <90 min. METHODS: Included were transfer STEMI patients from 9 network hospitals treated in 2007 compared with 2008 to 2011 after installing the following initiatives: 1) established hospital referral system; 2) goal-oriented performance protocols; 3) expedited transport by ground or air; 4) first hospital activation of the PCI hospital catheterization laboratory; and 5) outreach coordinator and patient-level web-based feedback to the referring hospital. RESULTS: A total of 101 STEMI patients transported in 2007 were compared with 442 STEMI patients transferred after starting these initiatives for STEMI from 2008 to 2011, with the median door-in to door-out time decreased from 44 to 35 min (p < 0.0001), the median 1st D2B decreasing from 109.5 to 88.0 min (p < 0.0001), and the percentage under 90 min increased from 22.8% to 55.9% (p < 0.0001). Overall, throughout the study period (2007 to 2011), the transport times remained consistent (median 36.5 vs. 36.0 min, p = 0.98), whereas the PCI hospital D2B decreased from 20.0 to 16.0 min (p < 0.0001). Length of stay and in-hospital mortality remained low at 3.0 days and under 4%, respectively. CONCLUSIONS: A system-wide network program can achieve sustained (over 4 years) 1st D2B times of <90 min.

Lung T-cell responses to nontypeable Haemophilus influenzae in patients with chronic obstructive pulmonary disease.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is characterized by pulmonary inflammation that persists after the cessation of smoking. T cells have a major role in driving inflammation in patients with COPD and are activated by specific antigens to produce mediators, such as cytokines. The antigens that activate lung T cells have not been clearly defined. Nontypeable Haemophilus influenzae (NTHi) is the dominant bacterium isolated from the lungs of patients with COPD. OBJECTIVE: We sought to measure the response of lung tissue T cells to stimulation with NTHi. METHODS: We obtained lung tissue from 69 subjects having lobectomies for lung cancer. Of the group, 39 subjects had COPD, and 30 without COPD were classified as control subjects. The lung tissue was dispersed into single-cell suspensions and stimulated with live NTHi. Cells were labeled with antibodies for 5 important inflammatory mediators in patients with COPD and analyzed by using flow cytometry. RESULTS: NTHi produced strong activation of both TH cells and cytotoxic T cells in the COPD cohort. The COPD cohort had significantly higher levels of cells producing TNF-α, IL-13, and IL-17 in both T-cell subsets. When control subjects were divided into those with and without a significant smoking history and compared with patients with COPD, there was a progressive increase in the numbers of T cells producing cytokines from nonsmoking control subjects to smoking control subjects to patients with COPD. CONCLUSION: NTHi activates lung T cells in patients with COPD. This proinflammatory profibrotic response might be a key cause of inflammation in patients with COPD and has implications for treatment.

Collecting data on quality is feasible in community-based palliative care.

BACKGROUND: Quality measurement in palliative care requires robust data from standardized data collection processes. We developed and tested the feasibility of the Quality Data Collection Tool version 1.0 (QDACTv1.0) for use in community-based palliative care. MEASURES: To evaluate for implementation barriers, we tested feasibility, acceptability, and utility of the QDACTv1.0 by reviewing use patterns, surveying clinician users, and reporting conformance with quality metrics. INTERVENTION: Comprising 37 questions within five domains, QDACTv1.0 was launched in May 2008 for data collection at point of care. OUTCOMES: Through March 2011, data on 5959 patients in 19,734 visits have been collected. We observed steady quarterly growth in data collection, positive clinician feedback, and successful mapping of data to quality metrics. Information gathered characterized practice variations and suggested quality improvement initiatives. Clinician feedback has driven updating to Quality Data Collection Tool version 2.0. CONCLUSIONS/LESSONS LEARNED: Standardized data collection is feasible in routine community-based palliative care and is valuable for quality monitoring.

Palliative care needs of patients with cancer living in the community.

PURPOSE: With improved effectiveness of early detection and treatment, many patients with cancer are now living with advanced disease and associated symptoms. As cancer becomes a chronic illness, adequate attention to patients' symptoms and psychosocial needs in the community setting requires positioning of palliative care alongside cancer care. This article describes the current palliative care needs of a population of community-dwelling patients with advanced cancer who are not yet ready for transition to hospice. METHODS: This secondary analysis used quality-monitoring data collected in three community-based palliative care organizations. Analyses focused on people with cancer-related diagnoses who were receiving palliative care during 2008 to 2011. RESULTS: The analytic data set included 4,980 people, 10% of whom had cancer. Median age was 71 years. Forty-eight percent had been hospitalized at least once in the 6 months before palliative care referral. Forty-nine percent had a Palliative Performance Score (PPS) of 40% to 60%; 40% had PPS ≤ 30%. Although 81% had an estimated prognosis of ≤ 6 months, 58% were expected to live weeks to months. Thirty-three percent had no identified healthcare surrogate; 59% had no do-not-resuscitate order despite declining functional status and limited prognosis. Ninety-five percent reported ≥ 1 symptom, and 67% reported ≥ 3 symptoms; a substantial proportion did not receive treatment for symptoms. CONCLUSIONS: Patients referred to community-based palliative care experience multiple often-severe symptoms that have been insufficiently addressed. They tend to have declining performance status. Earlier palliative care intervention could improve outcomes but will require delivery models that better coordinate inpatient/outpatient oncology and community-based palliative care.

Pharmacodynamic assessment of platelet inhibition by prasugrel vs. clopidogrel in the TRITON-TIMI 38 trial.

AIMS: To examine the extent of platelet inhibition by prasugrel vs. clopidogrel in a TRITON-TIMI 38 substudy. METHODS AND RESULTS: TRITON-TIMI 38 randomized acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI) to prasugrel or standard dose clopidogrel. Selected sites prospectively enrolled TRITON-TIMI 38 patients to evaluate adenosine diphosphate (ADP)-attenuated phosphorylation of platelet vasodilator-stimulated phosphoprotein (VASP) (n = 125 patients) and, in a subset (n = 31 patients), ADP-stimulated platelet aggregation. VASP platelet reactivity index (PRI) was lower in prasugrel-treated patients than in clopidogrel-treated patients at 1-2 h post-PCI (>or=1 h after loading dose) (P < 0.001) and at 30 days (P < 0.001). Maximal platelet aggregation to 20 microM ADP was lower in prasugrel-treated patients than in clopidogrel-treated patients at 1-2 h (P = 0.004) and 30 days (P = 0.03). Results were similar with 5 microM ADP. Thienopyridine hyporesponsiveness, prespecified as VASP PRI >50%, was more frequent in clopidogrel-treated patients than in prasugrel-treated patients at 1-2 h (P < 0.001) and 30 days (P = 0.03). CONCLUSIONS: The TRITON-TIMI 38 platelet substudy shows that prasugrel results in greater inhibition of ADP-mediated platelet function in ACS patients than clopidogrel, supporting the hypothesis that greater platelet inhibition leads to a lower incidence of ischaemic events and more bleeding both early and late following PCI.

Ionic low-osmolar versus nonionic iso-osmolar contrast media to obviate worsening nephropathy after angioplasty in chronic renal failure patients: the ICON (Ionic versus non-ionic Contrast to Obviate worsening Nephropathy after angioplasty in chronic renal failure patients) study.

OBJECTIVES: This randomized, prospective, double-blind, multicenter study compared nephrotoxicity of the nonionic iso-osmolar contrast media (CM) iodixanol versus the ionic low-osmolar CM ioxaglate in patients with chronic renal insufficiency undergoing coronary angiography. BACKGROUND: The properties of iodinated CM might contribute to the incidence of contrast-induced nephropathy (CIN). METHODS: Patients with renal impairment undergoing coronary angiography were randomly assigned to iodixanol (n = 72) or ioxaglate (n = 74). RESULTS: Baseline characteristics were well-matched between the 2 groups. The predicted risk score for CIN was similar in the iodixanol and in the ioxaglate groups (11.9 +/- 4.1 vs. 11.8 +/- 4.1), as was the use of N-acetylcysteine (70% vs. 73%). The primary end point of the study, median peak increase of serum creatinine from day 0 through day 3 after angiography, did not differ between the iodixanol (0.09 mg/dl; interquartile range 0.00 to 0.30 mg/dl) and the ioxaglate (0.15 mg/dl; interquartile range 0.00 to 0.40 mg/dl; p = 0.07) groups. The percentages of patients with a peak increase of serum creatinine >or=0.5 mg/dl (15.9% in iodixanol vs. 18.2% in ioxaglate), >or=1.0 mg/dl (1.4% vs. 4.5%), and >or=25% or >or=0.5 mg/dl (15.9% vs. 24.2%, respectively) also did not differ significantly between the 2 groups. CONCLUSIONS: In high-risk patients undergoing coronary angiographic procedures, use of the nonionic iso-osmolar CM iodixanol does not reduce renal deterioration in patients with renal impairment, compared with the ionic low-osmolar CM ioxaglate. Given that the study was underpowered to compare nephrotoxicity of the 2 groups under the active medical protection of CIN, a larger randomized study is warranted that will enroll patients with higher risks of CIN under a strict control of hydration regimens and adjunctive medications.

Outcomes with drug-eluting stents versus bare metal stents in acute ST-elevation myocardial infarction: results from the Strategic Transcatheter Evaluation of New Therapies (STENT) Group.

OBJECTIVES: This study compares outcomes with drug-eluting stents (DES) versus bare metal stents (BMS) in patients with ST-elevation myocardial infarction (STEMI). BACKGROUND: DESs have been effective in elective percutaneous coronary intervention (PCI), but their safety and efficacy in patients with STEMI have not been well studied. METHODS: The STENT Registry is a multicenter United States registry evaluating outcomes of DES. Our study population includes patients with STEMI treated with either a DES or BMS who completed 9-month or 2-year follow-up. Outcomes were adjusted using propensity score analysis. RESULTS: DES patients were younger, had less prior infarction and prior bypass surgery, but had smaller vessels and longer lesions. After adjusting for differences in baseline variables, there were no significant differences between DES and BMS in death, reinfarction, or major adverse cardiac events (MACE). DES had lower rates of stent thrombosis at 9 months (1.0% vs. 2.7%, HR 0.40 [0.17-0.95]) and lower rates of target vessel revascularization (TVR) at 9 months (4.0% vs. 7.5%, HR 0.55 [0.34-0.88]) and 2 years (8.0% vs. 11.3%, HR 0.57 [0.35-0.92]). There was a nonsignificant increase in stent thrombosis with DES versus BMS from 1 to 2 years (1.1% vs. 0.3%, P = 0.28). CONCLUSIONS: Our data suggest that DES used with primary PCI for STEMI are more effective than BMS in reducing TVR and are safe for up to 2 years. Whether DES are safe beyond 2 years and whether the reduction in TVR is enough to justify their use in STEMI will have to wait for the results of large randomized trials.

Intensive oral antiplatelet therapy for reduction of ischaemic events including stent thrombosis in patients with acute coronary syndromes treated with percutaneous coronary intervention and stenting in the TRITON-TIMI 38 trial: a subanalysis of a randomised trial.

BACKGROUND: Intracoronary stenting can improve procedural success and reduce restenosis compared with balloon angioplasty in patients with acute coronary syndromes, but can also increase the rate of thrombotic complications including stent thrombosis. The TRITON-TIMI 38 trial has shown that prasugrel-a novel, potent thienopyridine-can reduce ischaemic events compared with standard clopidogrel therapy. We assessed the rate, outcomes, and prevention of ischaemic events in patients treated with prasugrel or clopidogrel with stents in the TRITON-TIMI 38 study. METHODS: Patients with moderate-risk to high-risk acute coronary syndromes were included in our analysis if they had received at least one coronary stent at the time of the index procedure following randomisation in TRITON-TIMI 38, and were further subdivided by type of stent received. Patients were randomly assigned in a 1 to 1 fashion to receive a loading dose of study drug (prasugrel 60 mg or clopidogrel 300 mg) as soon as possible after randomisation, followed by daily maintenance therapy (prasugrel 10 mg or clopidogrel 75 mg). All patients were to receive aspirin therapy. Treatment was to be continued for a minimum of 6 months and a maximum of 15 months. Randomisation was not stratified by stents used or stent type. The primary endpoint was the composite of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke. Stent thrombosis was assessed using Academic Research Consortium definitions, and analysis was by intention to treat. TRITON-TIMI 38 is registered with ClinicalTrials.gov, number NCT00097591. FINDINGS: 12,844 patients received at least one coronary stent; 5743 received only drug-eluting stents, and 6461 received only bare-metal stents. Prasugrel compared with clopidogrel reduced the primary endpoint (9.7 vs 11.9%, HR 0.81, p=0.0001) in the stented cohort, in patients with only drug-eluting stents (9.0 vs 11.1%, HR 0.82, p=0.019), and in patients with only bare-metal stents (10.0 vs 12.2%, HR 0.80, p=0.003). Stent thrombosis was associated with death or myocardial infarction in 89% (186/210) of patients. Stent thrombosis was reduced with prasugrel overall (1.13 vs 2.35%, HR 0.48, p<0.0001), in patients with drug-eluting stents only (0.84 vs 2.31%, HR 0.36, p<0.0001), and in those with bare-metal stents only (1.27 vs 2.41%, HR 0.52, p=0.0009). INTERPRETATION: Intensive antiplatelet therapy with prasugrel resulted in fewer ischaemic outcomes including stent thrombosis than with standard clopidogrel. These findings were statistically robust irrespective of stent type, and the data affirm the importance of intensive platelet inhibition in patients with intracoronary stents.

Outcomes and complications with off-label use of drug-eluting stents: results from the STENT (Strategic Transcatheter Evaluation of New Therapies) group.

OBJECTIVES: This study evaluates outcomes and complications in patients treated with drug-eluting stents (DES) for "off-label" indications. BACKGROUND: Drug-eluting stents have been effective in randomized trials, but their safety and efficacy for off-label indications has not been well studied. METHODS: The STENT (Strategic Transcatheter Evaluation of New Therapies) Registry is the largest multicenter U.S. registry evaluating outcomes of DES. Off-label indications included ostial, left main, long, bifurcation, and in-stent restenotic lesions, saphenous vein grafts, chronic total occlusions, small or large vessels, multilesion or multivessel percutaneous coronary interventions, and ST-segment elevation myocardial infarction. Outcomes were adjusted using Cox proportional hazards regression and propensity analyses. RESULTS: Drug-eluting stents were used in an off-label manner in 59% of patients. The patients who received off-label treatment were more often male, had a higher incidence of prior infarction and bypass surgery, and lower ejection fractions. Off-label versus "on-label" use of DES was associated with higher rates of death, myocardial infarction, target vessel revascularization, major adverse cardiac events, and stent thrombosis at 9 months and 2 years. Off-label use of DES compared with off-label use of bare-metal stents (BMS) had lower rates of death, myocardial infarction, target vessel revascularization, and major adverse cardiac events at 9 months and 2 years and lower rates of stent thrombosis at 9 months. CONCLUSIONS: Off-label use of DES is associated with higher event rates compared with on-label use of DES, which is consistent with a higher risk clinical and lesion profile. However, event rates with off-label use of DES are lower compared with off-label use of BMS. Pending results from randomized trials, our data support the use of DES for off-label indications in selected patients.

Comparison of late survival in patients with cardiogenic shock due to right ventricular infarction versus left ventricular pump failure following primary percutaneous coronary intervention for ST-elevation acute myocardial infarction.

This study compared late survival after primary percutaneous coronary intervention (PCI) in patients with cardiogenic shock due to right ventricular (RV) infarction versus left ventricular (LV) pump failure. Consecutive patients with ST-elevation myocardial infarction treated with primary PCI (n = 2,496) were prospectively enrolled in a registry from 1984 to 2004. Cardiogenic shock occurred before PCI in 189 patients (7.6%). Shock was attributed to predominant RV infarction when there was right coronary artery occlusion with preserved LV function and increased right atrial pressure. Patients with shock due to RV infarction (n = 30) versus LV pump failure (n = 136) had fewer previous infarctions (10% vs 29%, p = 0.03), less multivessel disease (20% vs 47%, p = 0.007), higher right atrial pressure (21 vs 16 mm, p = 0.003), and better LV ejection fraction (57% vs 32%, p <0.001). In-hospital mortality was lower with shock due to RV infarction (23% vs 50%, p = 0.01), and shock due to RV infarction was a significant independent predictor of late cardiac survival (hazard ratio 0.28, 95% confidence interval 0.13 to 0.62, p = 0.002). In conclusion, survival after primary PCI in patients with shock due to RV infarction is better than that in patients with shock due to LV pump failure. This is in contrast to most previous reports. Improved survival is likely related to lower risk profile and previously documented substantial recovery of RV function after primary PCI.

Case managers' roles and functions: Commission for Case Manager Certification's 2004 research, part II.

The Commission for Case Manager Certification (CCMC) conducted its third case managers' role and functions study in 2004 for the purpose of validating the currency and relevancy of the certified case manager examination. The results of this study are shared in an article of 2 parts. Part I, which was published in the previous issue of this journal, discussed the process the CCMC used for the development of the Case Managers' Role and Functions Survey Instrument and the identification of new 6 essential functions and 6 knowledge areas that describe case management practice. These findings were based on the survey of a large national sample of practicing case managers. Part II continues the analysis of the results and focuses on identifying the empirical (statistically derived) activity and knowledge domains of case management practice, using exploratory factor analysis. It discusses the similarities and differences found among various subgroups of case managers who were compared on the basis of certain demographic variables. In addition, Part II summarizes future changes in the field of case management as perceived by those who participated in the study.

Door-to-balloon time with primary percutaneous coronary intervention for acute myocardial infarction impacts late cardiac mortality in high-risk patients and patients presenting early after the onset of symptoms.

OBJECTIVES: The purpose of this study was to evaluate the impact of door-to-balloon time with primary percutaneous coronary intervention (PCI) on late cardiac mortality. BACKGROUND: The impact of door-to-balloon time on outcomes is controversial, and the impact on late mortality has not been studied. METHODS: Consecutive patients (n = 2,322) treated with primary PCI from 1984 to 2003 were prospectively identified and followed up for a median of 83 months. RESULTS: Prolonged door-to-balloon times (0 to 1.4 h vs. 1.5 to 1.9 h vs. 2.0 to 2.9 h vs. > or =3.0 h) were associated with higher in-hospital mortality (4.9% vs. 6.1% vs. 8.0% vs. 12.2%, p < 0.0001) and late mortality (12.6% vs. 16.4% vs. 20.4% vs. 27.1% at 7 years, p < 0.0001) and were an independent predictor of late mortality by Cox regression (p = 0.0004). Prolonged door-to-balloon times (> or =2 h vs. <2 h) were associated with higher late mortality in high-risk patients (32.5% vs. 21.5%; hazard ratio [HR], 1.53; 95% confidence interval [CI], 1.22 to 1.90; p = 0.0002) but not in low-risk patients (10.8% vs. 9.2%; HR, 1.13; 95% CI, 0.78 to 1.64; p = 0.53) and in patients presenting early (< or =3 h) (24.7% vs. 15.0%; HR, 1.54; 95% CI, 1.24 to 1.90; p = 0.0001) but not late (>3 h) (21.1% vs. 18.5%; HR, 0.95; 95% CI, 0.62 to 1.45; p = 0.80). CONCLUSIONS: Delays in door-to-balloon time impact late survival in high-risk but not low-risk patients and in patients presenting early but not late after the onset of symptoms. These findings have implications for the triage of patients for primary PCI.

Case managers' roles and functions: Commission for Case Manager Certification's 2004 Research, Part I.

The Commission for Case Manager Certification (CCMC) conducted its third case managers' role and functions study in 2004. The purpose of this research was to validate the currency and relevancy of the certified case manager examination. The results of this study are shared in 2 parts of an article. Part I discusses the process the CCMC used for the development of the Case Manager's Role and Functions Survey Instrument (CMRFSI). The research leads to the identification of 6 new essential functions and 6 new knowledge areas, which describe case management practice. These findings were based on the survey of a large national sample of practicing case managers. Part II continues the analysis of the survey results and focuses on identifying the empirical activity and knowledge domains of case management practice, using factor analysis. It also discusses the similarities and differences found among various subgroups of case managers who were compared on the basis of certain demographic variables. In addition, it summarizes future changes in the field of case management as perceived by those who participated in the study.

A blinded, randomized, placebo-controlled trial of percutaneous laser myocardial revascularization to improve angina symptoms in patients with severe coronary disease.

OBJECTIVES: This study was a randomized, patient- and evaluator-blinded, placebo-controlled trial in patients treated using percutaneous myocardial laser revascularization. BACKGROUND: Previous studies using similar therapies have been confounded by placebo bias. METHODS: A total of 298 patients with severe angina were randomly assigned to receive low-dose or high-dose myocardial laser channels or no laser channels, blinded as a sham procedure. The primary end point was the change in exercise duration from baseline examination to six months. RESULTS: The incidence of 30-day death, stroke, myocardial infarction, coronary revascularization, or left ventricular perforation occurred in two patients in the placebo, eight patients in the low-dose, and four patients in the high-dose groups (p = 0.12); 30-day myocardial infarction incidence was higher in patients receiving either low-dose or high-dose laser (nine patients) compared with placebo (no patients, p = 0.03). At six months, there were no differences in the change in exercise duration between those receiving a sham (28.0 s, n = 100), low-dose laser (33.2 s, n = 98), or high-dose laser (28.0 s, n = 98, p = 0.94) procedure. There were also no differences in the proportion of patients improving to better than Canadian Cardiovascular Society class III angina symptoms at six months. The follow-up visual summed stress single-photon-emission computed tomography scores were not significantly different from baseline in any group and were no different between groups. The modest improvement in angina symptoms assessed by the Seattle Angina Questionnaire also was not statistically different among the arms. CONCLUSIONS: Treatment with percutaneous myocardial laser revascularization provides no benefit beyond that of a similar sham procedure in patients blinded to their treatment status.

Poor long-term patient and graft survival after primary percutaneous coronary intervention for acute myocardial infarction due to saphenous vein graft occlusion.

Primary percutaneous coronary intervention (PCI) for ST segment elevation myocardial infarction (STEMI) due to saphenous vein graft (SVG) occlusion has been associated with poor procedural results and poor short-term outcomes, but long-term graft patency and patient survival have not been evaluated. Consecutive patients (n = 2,240) with STEMI treated with primary PCI from 1984 to 2003 were followed for 6.6 years (median). Follow-up angiography was obtained in 80% of hospital survivors following primary PCI for SVG occlusion at 2.3 years (median). Patients with primary PCI for SVG occlusion (n = 57) vs. native artery occlusion had more prior MI, advanced Killip class, and three-vessel coronary disease and lower acute ejection fraction (EF). Patients with SVG occlusion had lower rates of TIMI 3 flow post-PCI (80.7% vs. 93.6%; P = 0.0001), higher in-hospital mortality (21.1% vs. 8.0%; P = 0.0004), and lower follow-up EF (49.3% vs. 54.7%; P = 0.055). Culprit SVGs were patent in 64% of patients at 1 year and 56% at 5 years. Late survival was strikingly worse in patients with primary PCI for SVG occlusion vs. native vessel occlusion (49% vs. 76% at 10 years), and SVG occlusion was the second strongest predictor of late cardiac mortality by multivariate analysis (HR = 2.11; 95% CI = 1.38-3.23; P = 0.0006). Patients with STEMI due to SVG occlusion treated with primary PCI have poor acute procedural results, frequent late reocclusion, and very high late mortality. The introduction of new adjunctive therapies (distal protection, thrombectomy, and drug-eluting stents) may improve short-term outcomes, but improved long-term outcomes may require new and more durable revascularization strategies.