Relationship Between HCAHPS Scores and Survey Response Rate Is Linked to Hospital Size.

Patient experience is an important dimension of health care quality and is assessed using the standard Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey for inpatients. The HCAHPS scores may vary based on survey response rate and hospital size. The objective of this study was to describe the association between survey response rate and HCAHPS scores and examine whether the relationship varies based on hospital size. Medicare's Hospital Compare publicly reported HCAHPS data were used. Pearson correlation, controlling for number of staffed beds, and linear regression models were used for the analysis. Hospitals were grouped into quartiles based on number of staffed beds to delineate the effect of increasing hospital size on the relationship between survey response rate and HCAHPS scores. A significant association between HCAHPS survey response rate and all examined HCAHPS domain scores was observed. The effect size across HCAHPS domains varied based on hospital size. The relationship between HCAHPS score and survey response rate differed significantly between hospitals in the smallest and largest size quartiles for discharge information, nurse communication, and hospital quietness. While a causal relationship cannot be inferred from this study, the response rate could be a direct and/or indirect driver of HCAHPS scores. Future research should be aimed to further explore the basis of this relationship and to determine how it may inform the interpretation of HCAHPS results.

Analysis of geographic variations in the diagnosis and treatment of patients with aortic stenosis in North Carolina.

Despite advances in the treatment of aortic stenosis (AS), many patients with AS remain untreated. Barriers to accessing cardiovascular surgical care may play a role in this undertreatment. We sought to examine whether there are geographic variations in the treatment of AS within North Carolina that may reflect differential access to care. Hospital discharge data from North Carolina hospitals during federal fiscal year 2010 were analyzed from the Thomson Reuters database. Patients hospitalized with AS were identified using International Classification of Diseases, ninth revision (ICD-9) diagnosis codes. ICD-9 procedure codes were used to identify patients who had aortic valve replacement and other cardiac procedures. The rates of hospitalizations for AS and aortic valve replacement were calculated per county in North Carolina. In fiscal year 2010, there were 12,111 patients who were discharged from a North Carolina hospital with AS listed as one of the ICD-9 discharge diagnosis codes. The median age for this population was 79 (twenty-fifth to seventy-fifth), with approximately 1/3 patients (28.9%) being at least 85 years of age and >1/2 being female (53.8%). Of them, 1,608 patients underwent valvular surgery with an in-hospital mortality rate of 3.3%. The highest rates, corrected for county population, of hospitalizations where AS was listed as the primary diagnosis were in the most rural segments of North Carolina while those same areas had the lowest rates of valvular surgery. In conclusion, there are significant geographic variations in the rates of hospitalization for AS and for valvular surgery within North Carolina. The most rural segments of the state have the highest rates of hospitalization while also having the lowest rates of surgery. This suggests geographic treatment disparities as a result of access to surgical care that must be considered as new therapies for AS, such as transcatheter aortic valve replacement, are deployed.

Detailed analysis of polymer response to delivery balloon expansion of drug-eluting stents versus bare metal stents.

AIMS: We sought to describe the response of the polymer surface of drug-eluting stents (DES) to delivery balloon expansion, including quantitation of any resulting detached microparticles. METHODS AND RESULTS: We expanded the US Food and Drug Administration (FDA)-approved first- and second-generation DES in a vacuum filtration system and used optical and scanning electron microscopy to image the polymer surface, filters and delivery balloons. DES were expanded under a range of conditions, from in vitro conditions used for FDA regulatory submissions to human in vivo conditions. Dispersive Raman spectroscopy was used for definitive identification of microparticles. All polymer surfaces were topographically disturbed over an average of 4.6%-100% of the surface area imaged. Disturbances ranged from deformation (including peeling) to complete delamination. The dimensions of detached microparticles were 2-350 µm. The extent and nature of surface disturbances and microparticles were primarily a function of polymer composition (p<0.001 for 8/10 disturbance types/locations) and were independent of expansion condition (p=0.100 to 0.989 for 9/10 disturbance types/locations). CONCLUSIONS: Balloon expansion of first- and second-generation DES disturbs the polymer surface and can cause detachment of microparticles; each is functionally related to the specific polymer but not to expansion condition. Disturbance "roughness" and detached microparticles may contribute to DES limitations.

Cardioprotective proteins upregulated in the liver in response to experimental myocardial ischemia.

Myocardial ischemia (MI) activates innate cardioprotective mechanisms, enhancing cardiomyocyte tolerance to ischemia. Here, we report a MI-activated liver-dependent mechanism for myocardial protection. In response to MI in the mouse, hepatocytes exhibited 6- to 19-fold upregulation of genes encoding secretory proteins, including α-1-acid glycoprotein (AGP)2, bone morphogenetic protein-binding endothelial regulator (BMPER), chemokine (C-X-C motif) ligand 13, fibroblast growth factor (FGF)21, neuregulin (NRG)4, proteoglycan 4, and trefoil factor (TFF)3. Five of these proteins, including AGP2, BMPER, FGF21, NRG4, and TFF3, were identified as cardioprotective proteins since administration of each protein significantly reduced the fraction of myocardial infarcts (37 ± 9%, 34 ± 7%, 32 ± 8%, 39 ± 6%, and 31 ± 7%, respectively, vs. 48 ± 7% for PBS at 24 h post-MI). The serum level of the five proteins elevated significantly in association with protein upregulation in hepatocytes post-MI. Suppression of a cardioprotective protein by small interfering (si)RNA-mediated gene silencing resulted in a significant increase in the fraction of myocardial infarcts, and suppression of all five cardioprotective proteins with siRNAs further intensified myocardial infarction. While administration of a single cardioprotective protein mitigated myocardial infarction, administration of all five proteins furthered the beneficial effect, reducing myocardial infarct fractions from PBS control values from 46 ± 6% (5 days), 41 ± 5% (10 days), and 34 ± 4% (30 days) to 35 ± 5%, 28 ± 5%, and 24 ± 4%, respectively. These observations suggest that the liver contributes to cardioprotection in MI by upregulating and releasing protective secretory proteins. These proteins may be used for the development of cardioprotective agents.

Ischemia change in stable coronary artery disease is an independent predictor of death and myocardial infarction.

OBJECTIVES: The aim of this study was to evaluate the independent prognostic significance of ischemia change in stable coronary artery disease (CAD). BACKGROUND: Recent randomized trials in stable CAD have suggested that revascularization does not improve outcomes compared with optimal medical therapy (MT). In contrast, the nuclear substudy of the COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) trial found that revascularization led to greater ischemia reduction and suggested that this may be associated with improved unadjusted outcomes. Thus, the effects of MT versus revascularization on ischemia change and its independent prognostic significance requires further investigation. METHODS: From the Duke Cardiovascular Disease and Nuclear Cardiology Databanks, 1,425 consecutive patients with angiographically documented CAD who underwent 2 serial myocardial perfusion single-photon emission computed tomography scans were identified. Ischemia change was calculated for patients undergoing MT alone, percutaneous coronary intervention, or coronary artery bypass grafting. Patients were followed for a median of 5.8 years after the second myocardial perfusion scan. Cox proportional hazards regression modeling was used to identify factors independently associated with the primary outcome of death or myocardial infarction (MI). Formal risk reclassification analyses were conducted to assess whether the addition of ischemia change to traditional predictors resulted in improved risk classification for death or MI. RESULTS: More MT patients (15.6%) developed ≥5% ischemia worsening compared with those undergoing percutaneous coronary intervention (6.2%) or coronary artery bypass grafting (6.7%) (p < 0.001). After adjustment for established predictors, ≥5% ischemia worsening remained a significant independent predictor of death or MI (hazard ratio: 1.634; p = 0.0019) irrespective of treatment arm. Inclusion of ≥5% ischemia worsening in this model resulted in significant improvement in risk classification (net reclassification improvement: 4.6%, p = 0.0056) and model discrimination (integrated discrimination improvement: 0.0062, p = 0.0057). CONCLUSIONS: In stable CAD, ischemia worsening is an independent predictor of death or MI, resulting in significantly improved risk reclassification when added to previously known predictors.

Comparison of Clinical characteristics and long-term outcomes of patients with ischemic cardiomyopathy with versus without angina pectoris (from the Duke Databank for Cardiovascular Disease).

Myocardial ischemic origin is a significant independent predictor of mortality in patients with heart failure (HF). The implications of angina pectoris (AP) in HF are less well characterized. The aim of this study was to compare the clinical characteristics and outcomes of patients with and without AP in a cohort of patients with reduced ejection fractions and ischemic cardiomyopathy (iCM). Patients who underwent coronary angiography at Duke University Medical Center from January 2000 to September 2009 with ejection fractions <40% and diagnoses of iCM with AP in the previous 6 weeks were compared to similar patients without AP. Time to event was examined using Kaplan-Meier methods for 5 end points: death; death or nonfatal myocardial infarction (MI); death, MI, or revascularization; death or hospitalization; and cardiovascular (CV) death or CV hospitalization. Of 2,376 patients with iCM, 1,412 (59%) had AP. They had more co-morbidities and more previous revascularization than patients without AP. After multivariate adjustment, those with and without AP had similar risks for death (p = 0.32), death or MI (p = 0.15), and death or hospitalization (p = 0.37) (5-year event rates 41% vs 41%, 46% vs 47%, and 87% vs 85%, respectively), but those with AP had lower rates of death, MI, or revascularization (p = 0.01) and higher rates of CV death or CV hospitalization (p = 0.03) (5-year event rates 85% vs 87% and 77% vs 73%, respectively). In conclusion, AP is common in patients with iCM despite medical therapy and previous revascularization and is associated with increased CV death or CV rehospitalization.

Long-term survival of patients with ischemic cardiomyopathy treated by coronary artery bypass grafting versus medical therapy.

BACKGROUND: We prospectively applied the Surgical Treatment of Ischemic Cardiomyopathy trial entry criteria to an observational database to determine whether coronary artery bypass grafting (CABG) decreases mortality compared with medical therapy (MED) for patients with coronary artery disease and depressed left ventricular ejection fraction. METHODS: This was a retrospective, observational, cohort study of prospectively collected data from the Duke Databank for Cardiovascular Disease. Long-term mortality was the main outcome measure. Between January 1, 1995, and July 31, 2009, 86,874 patients underwent cardiac catheterization for suspected ischemic heart disease and were evaluated for inclusion in the analysis. RESULTS: A total of 2,624 patients were found to have left ventricular ejection fraction less than 0.35, coronary artery disease amenable to CABG, and no left main stenosis of greater than 50%. After exclusions including ongoing Canadian Cardiovascular Society class III angina and acute myocardial infarction, 763 patients were included for propensity score analysis, including 624 who received MED and 139 who underwent CABG. Adjusted mortality curves were constructed for those patients in the three quintiles most likely to receive CABG. The curves diverged early, with risk-adjusted mortality rates at 5 years of 46% for MED versus 29% for CABG, and the survival benefit of CABG over MED continued through 10 years of follow-up (hazard ratio, 0.63; 95% confidence interval, 0.45 to 0.88). CONCLUSIONS: Among a propensity-matched, risk-adjusted, observational cohort of patients with coronary artery disease, left ventricular ejection fraction less than 0.35, and no left main disease of greater than 50%, CABG is associated with a survival advantage over MED through 10 years of follow-up.

Trends in the use of diagnostic coronary angiography, percutaneous coronary intervention, and coronary artery bypass graft surgery across North Carolina.

BACKGROUND: Although variation in use of invasive coronary procedures has been shown, the relationship between invasive diagnostic cardiac catheterization (Cath) and subsequent revascularization with percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG) is not known. We evaluated the temporal trends and variation in invasive Cath, PCI, and CABG across hospital systems in North Carolina. METHODS: All Cath, PCI, and CABG procedures performed in North Carolina from 2003 to 2009 were identified using data reported in the annual North Carolina State Medical Facilities Plan. Rates and variation in procedure use, relative rates of PCI to Cath, CABG to Cath, and CABG to PCI were compared over the study period between hospitals that performed at least 25 Cath, 25 PCI, and 25 CABG procedures. RESULTS: The rates of all invasive procedures per 100,000 population declined: 24% for Cath, 16% for PCI, and 35% for CABG. However, the relative rate of PCI to Cath over the study period increased by 11%, whereas the relative rate of CABG to Cath decreased by 13%. Hospital level analysis showed significant variation in the relative rate of both PCI to Cath (10%-90%, P < .05) and CABG to Cath (5%-35%, P < .05). CONCLUSIONS: Although the use of all invasive cardiac procedures declined, the relative rate of PCI to Cath increased over the study period. There was also significant variation in the mode of revascularization (CABG and PCI) across hospital systems in North Carolina. Further research is needed to understand drivers of coronary revascularization.

Preliminary observations using optical coherence tomography to assess neointimal coverage of a metal stent in a porcine model.

BACKGROUND: Concerns surrounding late stent thrombosis have prompted the development of novel imaging techniques to assess neointimal coverage. Recent clinical studies have evaluated optical coherence tomography (OCT) to evaluate neointimal coverage, but pathologic correlation in an animal model is lacking. We assessed the hypothesis that OCT could accurately assess early neointimal coverage in a porcine model. METHODS: OCT imaging of bare metal stents in each coronary artery was performed at implantation (n=6), Day 4 (n=3), and Day 20 (n=3), and images were evaluated at three cross-sections per stented segment. Neointimal strut coverage was categorized by OCT as covered or uncovered, and neointimal thickness was determined (Day 20). Pathological correlation was obtained using scanning electron microscopy (SEM) to assess strut coverage (Day 4) and histomorphometry to quantify neointimal thickness (Day 20). RESULTS: At Day 4, OCT imaging detected 28 (26%) of 109 uncovered struts, and the ratio of uncovered/total strut area by SEM was 31%. All imaging modalities showed complete coverage at Day 20. Mean (+/-SE) neointimal thickness at Day 20 was 109+/-6 microm by OCT (n=116 struts) and 93+/-5 microm by pathology (n=68). Mean neointimal thickness on a segment-by-segment basis determined by OCT correlated with mean histomorphometric analysis (Reviewer 1: r=.74, P=.092 and Reviewer 2: r=0.60, P=.212). CONCLUSIONS: Day 4 represents an important time point for the assessment of early neointimal coverage in the porcine model. OCT imaging accurately assesses the extent and thickness of early neointimal coverage with good pathologic correlation. OCT represents a promising imaging modality for the in vivo assessment of neointimal coverage.

Vulnerable plaque intervention: State of the art.

Progressive atherosclerotic disease is responsible for many of the late adverse clinical events that detract from the high procedural and clinical success of percutaneous coronary intervention. Despite recent advances in catheter based technology for the treatment of obstructive coronary artery disease, the greater risk to the patient over time may in fact come from the significant rate of acute coronary events triggered by nonculprit and/or nonobstructive coronary artery lesions. These areas of vulnerability within the epicardial coronary tree have generated a great deal of interest surrounding the concepts of vulnerable plaque (VP), vulnerable blood and the vulnerable patient. This 'state of the art' review discusses the limitations of coronary angiography alone in providing risk assessment; reviews the underlying biological concepts of VP; discusses evolving noninvasive and invasive imaging technologies for the detection of VP; and finally provides a futuristic look at how the field of interventional cardiology may transcend the traditional angiogram and move toward a more comprehensive treatment approach that benefits the patients' overall coronary health.

Revascularization for heart failure.

Coronary artery disease is the most common underlying cause of heart failure, yet there is little consensus on the role of revascularization in the management of patients with ischemic cardiomyopathy. The concept of recovery of dysfunctional but viable myocardium forms the pathophysiologic basis for the benefit of revascularization. Data from observational studies suggest that patients with coronary disease and left ventricular dysfunction may have improved outcomes after surgical revascularization or percutaneous coronary intervention (PCI) compared to medical treatment. Viability testing may be useful in selecting a population of patients who will receive differential benefit. In the clinical management of patients with heart failure, clinicians face challenging decisions about whether to recommend revascularization especially in patients who do not have angina. As data from randomized trials are awaited, PCI and coronary artery bypass grafting may be considered as complimentary revascularization approaches. Registry data suggest a benefit of coronary artery bypass grafting over PCI in patients with reduced ejection fraction; however, in patients with focal disease and comorbidities including previous surgery, PCI is reasonable, especially if complete revascularization is possible.

Clinical implications of vulnerable plaque.

In many individuals, the first indicator of atherosclerosis is an acute heart attack, which is often fatal. Despite innovations in medical therapy and interventional cardiology techniques, coronary artery disease continues to be the leading cause of death in the USA. There is great interest in identifying vulnerable plaques and vulnerable patients as a possible means to stem the tide against coronary artery disease. Improvements in diagnostic studies and development of novel imaging tools have opened the possibilities for significant advances in the management of vulnerable plaque. The result of improved risk stratification, by both noninvasive and invasive means, will be a better assessment of the risk/benefit relationships for the novel therapies that are needed to further reduce the morbidity and mortality of the disease. Correct identification of vulnerable plaque would permit the use of more effective systemic treatment and enable clinical trials to study the supplemental benefit from local treatments.

Late thrombosis following treatment of in-stent restenosis with drug-eluting stents after discontinuation of antiplatelet therapy.

Drug-eluting stent usage has become commonplace for the percutaneous treatment of de novo coronary lesions, but the safety and efficacy profile for their evolving usage in restenotic lesions is largely unknown. We report three cases of angiographically confirmed drug-eluting stent thrombosis following treatment of restenotic lesions that occurred late (193, 237, and 535 days) and shortly after interruption of antiplatelet therapy. All three patients suffered ST elevation myocardial infarction, and there was one death. Further studies are necessary to better define the associated risk and ideal duration of antiplatelet therapy necessary in this cohort of patients with restenotic lesions.

Outcomes following elective percutaneous coronary intervention without on-site surgical backup in a community hospital.

Despite guidelines to the contrary, limited numbers of elective percutaneous coronary intervention (PCI) procedures without on-site surgical backup are being performed, particularly in Europe and Canada. In the United States, many hospitals are considering establishing on-site surgical programs, in part to facilitate PCI. At a hospital with only off-site surgical backup, 562 elective PCI procedures were performed on 489 consecutive patients. Of these, 551 (98.0%) were successfully completed without major in-hospital complications; 5 patients (1.0%) had in-hospital complications, and 4 (0.8%) were urgently transferred. It is concluded that elective PCI with off-site surgical backup is feasible and safe for selected patients under specific conditions.

Relationship between activated clotting time during percutaneous intervention and subsequent bleeding complications.

BACKGROUND: Approximately 50% of percutaneous coronary interventions in the United States are performed with unfractionated heparin and no IIb/IIIa agent. The operator must weigh the risks and benefits of more intensive anticoagulation during these percutaneous interventions. This study helps clarify the relationship between patient and procedural factors, such as the intensity of heparin anticoagulation as measured by activated clotting time (ACT), and the risk of blood loss and bleeding complications. METHODS: Four hundred twenty-nine patients undergoing elective or urgent percutaneous coronary intervention were followed up prospectively for 72 hours after intervention for clinical bleeding complications. Blood loss, defined as the difference between preprocedural and nadir postprocedural hematocrit adjusted for interval transfusions, was also tracked. In-laboratory ACTs, as well as other potential clinical and procedural predictors of blood loss and bleeding risk, were collected and analyzed. RESULTS: Maximum in-laboratory ACT was significantly related to blood loss as measured by the change in hematocrit (P =.017) and to the risk of major bleeding complications (P =.002). In multivariate analysis, patient age (P =.004), sex (P =.014), procedure length (P <.001), and additional interventions (P <.001) were significant, independent predictors of blood loss. Major bleeding complications were significantly, independently predicted by patient age (P <.001), additional interventions (P =.015), and maximum in-laboratory ACT (P <.001). CONCLUSIONS: Compared with the other clinical and procedural predictors of bleeding complications, maximum in-laboratory ACT was second only to patient age in significance as a multivariate predictor of postprocedural bleeding complications. Maximum in-laboratory ACT was found to be the most significant modifiable univariate and multivariate predictor of clinical bleeding complications after percutaneous coronary intervention. Particularly in patients with nonmodifiable risk factors for blood loss and bleeding complications such as advanced age, female sex, and multiple and prolonged procedures, avoiding high intensity anticoagulation with unfractionated heparin is associated with lower bleeding risk.

Inflammation, platelets, and glycoprotein IIb/IIIa inhibitors.

Atherosclerosis, with its thromboembolic complications (including sudden cardiac death, myocardial infarction, and other ischemic organ damage such as stroke and ischemic renovascular disease), represents by far the major cause of death, morbidity, and disability for industrialized countries, and is rapidly spreading worldwide. Atherosclerosis is also a paradigm for complex, multifactorial disorders that affect humans in an age-dependent fashion. Atherosclerosis has usually been studied in a descriptive framework of biological and clinical data gathered over more than a century. As such, it is a chronic inflammatory process that selectively affects arterial vessels, and is, at least in part, genetically predetermined. Despite spectacular progress in the cardiovascular discipline, with the development of therapeutic strategies that have substantially improved the outcome of affected patients, several key questions remain unanswered: Why is aging such a powerful risk for coronary artery disease? What is the triggering mechanism for atherosclerotic inflammation? Also, in the context of this and accompanying reviews, do we modify coronary inflammation with glycoprotein IIb/IIIa blockers? Recent progress in our understanding of the underlying process of atherosclerosis has provided us with the opportunity to refine the answers to some of these questions.

The complementary use of glycoprotein IIb/IIIa inhibitors and drug-eluting stents in contemporary percutaneous coronary intervention.

The percutaneous treatment of symptomatic, obstructive coronary artery disease continues to undergo evolutionary changes that have led to an increase in the number of procedures performed each year. Studies on the adjunctive use of thienopyridines and glycoprotein (GP) IIb/IIIa inhibitors during and following percutaneous coronary intervention (PCI) have demonstrated a reduction in the ischemic complications following PCI. One of the GP IIb/IIIa inhibitors, abciximab, has been shown to reduce mortality one year after successful PCI compared with placebo. Despite the reduction in ischemic complications and a potential reduction in mortality at one year, the antiplatelet agents have not consistently been shown to affect the rates of restenosis following PCI. Recent, exciting data on the use of drug-eluting stents (DES) in diseased coronary vessels has generated immense enthusiasm within the interventional community about the future ability to dramatically reduce the rates of restenosis following PCI with the use of this novel stent technology. With the introduction and assumed widespread use of these new stents, it appears that the contemporary interventional cardiologist will now have two complementary therapies available for use during percutaneous revascularization: GP IIb/IIIa inhibitors for the reduction of ischemic complications during and immediately following PCI, and DES for the prevention of long-term restenosis within the treated vessel segment. Caution should be taken not to view these valuable therapies as mutually exclusive but rather to recognize that each addresses critical aspects of percutaneous revascularization that have been improved upon after being studied in thousands of patients in controlled, randomized clinical trials.