Previous studies describing the no-reflow phenomenon in patients with acute myocardial infarction (AMI) undergoing percutaneous coronary intervention (PCI) were largely confined to single-center ...studies or small registries. To better characterize the incidence, predictors, and outcomes of the no-reflow phenomenon in a large contemporary population, we analyzed patients with AMI who were undergoing PCI of native coronary artery stenoses in the CathPCI Registry from January 1, 2004 through September 5, 2008 (n = 291,380). The angiographic no-reflow phenomenon was site reported using a standardized definition. No-reflow developed in 2.3% of the patients with AMI (n = 6,553) during PCI. Older age, ST-segment elevation AMI, prolonged interval from symptom onset to admission, and cardiogenic shock were clinical variables independently associated with the development of no-reflow (p <0.001). The angiographic factors independently associated with no-reflow included longer lesion length, higher risk class C lesions, bifurcation lesions, and impaired preprocedure Thrombolysis In Myocardial Infarction flow (p <0.001). No-reflow was associated with greater in-hospital mortality (12.6% vs 3.8%, adjusted odds ratio 2.20, 95% confidence interval 1.97 to 2.47, p <0.001) and unsuccessful lesion outcome (29.7% vs 6.6%, adjusted odds ratio 4.70, 95% confidence interval 4.28 to 5.17, p <0.001) compared to patients without no-reflow. In conclusion, the development of no-reflow, although relatively uncommon during PCI for AMI, is associated with adverse clinical outcomes. Upfront strategies to reduce the incidence of no-reflow could be considered for high-risk patients to improve outcomes.
Given the attendant risks of mortality and morbidity, acute MI remains a principal focus of cardiovascular therapeutics. ...30-day mortality and rehospitalization rates for acute MI are publicly ...reported in an effort to promote optimal acute MI care, and aspects of MI care delivery are the focus of local, regional, and national quality initiatives (1-3). Updates or revisions to the American College of Cardiology (ACC)/American Heart Association (AHA) practice guidelines for PCI, ST-segment elevation myocardial infarction (STEMI), and unstable angina (UA)/non-ST-segment elevation myocardial infarction (NSTEMI) have been published within the last 3 years, building upon prior versions published earlier in the decade (5-7).
Abstract Assessment of clinical outcomes such as 30-day mortality following coronary revascularization procedures has historically been used to spur quality improvement programs. Public reporting of ...risk-adjusted outcomes is already mandated in several states, and proposals to further expand public reporting have been put forward as a means of increasing transparency and potentially incentivizing high quality care. However, for public reporting of outcomes to be considered a useful surrogate of procedural quality of care, several prerequisites must be met. First, the reporting measure must be truly representative of the quality of the procedure itself, rather than be dominated by other underlying factors, such as the overall level of illness of a patient. Second, to foster comparisons among physicians and institutions, the metric requires accurate ascertainment of and adjustment for differences in patient risk profiles. This is particularly relevant for high-risk clinical patient scenarios. Finally, the potential deleterious consequences of public reporting of a quality metric should be considered prior to expanding the use of public reporting more broadly. In this viewpoint, the authors review in particular the characterization of high-risk patients currently treated by percutaneous coronary interventional procedures, assessing the adequacy of clinical risk models used in this population. They then expand upon the limitations of 30-day mortality as a quality metric for percutaneous coronary intervention, addressing the strengths and limitations of this metric, as well as offering suggestions to enhance its future use in public reporting.
Numerous definitions have been proposed for the diagnosis of myocardial infarction (MI) after coronary revascularization. The universal definition for MI designates post procedural biomarker ...thresholds for defining percutaneous coronary intervention (PCI)-related MI (type 4a) and coronary artery bypass grafting (CABG)-related MI (type 5), which are of uncertain prognostic importance. In addition, for both the MI types, cTn is recommended as the biomarker of choice, the prognostic significance of which is less well validated than CK-MB. Widespread adoption of a MI definition not clearly linked to subsequent adverse events such as mortality or heart failure may have serious consequences for the appropriate assessment of devices and therapies, may affect clinical care pathways, and may result in misinterpretation of physician competence. Rather than using an MI definition sensitive for small degrees of myonecrosis (the occurrence of which, based on contemporary large-scale studies, are unlikely to have important clinical consequences), it is instead recommended that a threshold level of biomarker elevation which has been strongly linked to subsequent adverse events in clinical studies be used to define a “clinically relevant MI.” The present document introduces a new definition for “clinically relevant MI” after coronary revascularization (PCI or CABG), which is applicable for use in clinical trials, patient care, and quality outcomes assessment.
Takotsubo cardiomyopathy (TC) is a reversible cardiomyopathy with a benign short-term prognosis but is associated with recurrence rate of 10%. Clinical variables that predict long-term mortality and ...recurrence are unknown; 56 consecutive patients presenting to a single urban medical center who fulfilled the Mayo Clinic criteria for the diagnosis of TC were included. Patients were followed with 100% completeness; >60 clinical factors were analyzed, including presentation, treatment, electrocardiogram, and echocardiographic, angiographic, and demographic variables. Survival analysis was performed using the Kaplan-Meier function and Cox proportional hazards regression models. There were 15 deaths during follow-up: 5 in-hospital, 4 before 90 days, and 6 after 90 days. Mean survival was 4.47 years (95% confidence interval 3.81 to 5.13). All short-term survivors had repeat ejection fraction evaluation demonstrating improvement; 45 of 56 patients were women and 96% were postmenopausal. The nonfatal recurrence rate was 1.8%. QTc interval at presentation was the factor most strongly predictive of overall outcome, after intubation. All patients with mortality had QTc intervals between 400 and 550 ms. In conclusion, this study demonstrates the prognostic significance of QTc prolongation at presentation in TC. Because the cause of TC involves intense catecholamine release and hyperadrenergic tone, the QTc may reflect the individual impact on myocardial repolarization and the balance between sympathetic innervation and parasympathetic compensation. In conclusion, in this series, TC was associated with an 8.9% in-hospital mortality, an additional 17.9% mortality after discharge, and a nonfatal recurrence rate of 1.8%. Moreover, the QTc on presentation with TC was predictive of outcome.
Stroke is a serious complication of percutaneous coronary intervention (PCI). Clinical characteristics associated with this complication have not been well defined. Data were analyzed from the ...National Cardiovascular Data Registry. All patients undergoing PCI from January 1, 2004, to March 30, 2007, were included in the analysis (n = 706,782). Stroke is defined in the National Cardiovascular Data Registry as a central neurologic deficit persisting >72 hours with onset starting anytime in the cardiac catheterization laboratory until the time of hospital discharge. Periprocedural stroke developed in 0.22% of patients (n = 1,540). Patients who developed a stroke had a greater prevalence of concomitant medical illnesses and were more likely to present with an acute coronary syndrome. Patients with a stroke had a greater percentage of high-risk coronary lesions and worse PCI angiographic results. In multivariable analysis, known cerebrovascular disease, older age, acute coronary syndromes (unstable angina, ST- and non–ST-elevation myocardial infarction), and use of an intra-aortic balloon pump were factors most strongly associated with stroke. In-hospital mortality was 30% for patients who developed a stroke compared with 1% for those without stroke. In conclusion, stroke developing in association with PCI is rare but a devastating complication. Older patients and those with known cerebrovascular disease and acute coronary syndromes appear to be at the highest risk of stroke. The strong association of in-hospital stroke after PCI with acute coronary syndromes is noteworthy.
In clinical trials, the use of a distal embolic protection device (EPD) during saphenous vein graft (SVG) percutaneous intervention (PCI) decreases the incidence of major adverse events. However, the ...frequency of EPD use during SVG PCI in clinical practice is unknown. We evaluated 19,546 SVG PCI procedures in the American College of Cardiology–National Cardiovascular Data Registry from January 1, 2004, through March 30, 2006. EPD use was the primary outcome. Univariate and multivariable analyses were used to assess for characteristics associated with EPD use and to determine the association between EPD use and 2 outcomes: no-reflow and in-hospital mortality. EPDs were used in 22% of patients who underwent SVG PCI. Characteristics independently associated with EPD use were age (odds ratio OR 1.04, p = 0.03), male gender (OR 1.12, p = 0.02), older grafts (p <0.001 for the group), longer lesions (OR 1.16, p <0.001), and American College of Cardiology/American Heart Association class C lesions (OR 1.41, p <0.001). Patients were less likely to receive an EPD if they had class <3 grade flow according to Thrombolysis in Myocardial Infarction classification (p <0.001) or previously treated lesions (OR 0.55, p <0.001). There was a weak correlation between annual hospital PCI volume and EPD use (r = 0.2, p <0.001). Nineteen percent of centers did not use EPDs and 41% used them in <10% of cases. EPD use was independently associated with a lower incidence of no-reflow (OR 0.68, p = 0.032), but not in-hospital mortality (1.0% vs 0.9%, p = NS). In conclusion, in current practice, EPDs are used in <25% of SVG PCI procedures.
Since the introduction of percutaneous coronary intervention (PCI) in 1977 by Andreas Gruntzig (1), the presence of cardiac surgery backup on site has been a recommended practice to treat the ...potential of life-threatening complications. ...there are few large studies that have directly compared the procedural outcomes of both primary and elective PCI at facilities without cardiac surgery on site with those that have traditional surgery on site (16-18). Because of the conflicting literature on this subject, the American College of Cardiology (ACC), American Heart Association (AHA), and Society for Cardiovascular Angiography and Interventions (SCAI) 2005 PCI guidelines continue to designate primary PCI a Class IIb indication (may be considered), and elective PCI a Class III indication (not recommended) when performed at facilities without surgical backup on site (19).
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