James M. McCabe

Usefulness and Safety of Ultrasound-Assisted Catheter-Directed Thrombolysis for Submassive Pulmonary Emboli

The optimal treatment for intermediate-risk pulmonary embolism (PE) remains unclear. Our goal was to describe the safety and efficacy of the EkoSonic ultrasound-assisted catheter-directed thrombolysis system (EKOS Corporation, Bothell, Washington) in a real-world registry of patients with intermediate-risk PE. Fifty-three consecutive patients with intermediate-risk PE treated with ultrasound-assisted catheter-directed thrombolysis at Brigham and Womens Hospital from 2010 to 2014 were analyzed. The primary outcome was a change in directly measured pulmonary artery pressures as assessed using logistic regression with generalized estimating equations to account for serial measurements. Patients received an average of 24.6 ± 9 mg of alteplase using the EKOS catheter with an average treatment time of 15.9 ± 3 hours. After treatment, there was a 7.2- and a 11.4-mm Hg reduction in mean and systolic pulmonary artery pressure (95% confidence interval 4.7 to 9.7 mm Hg, p <0.001, and 95% confidence interval 7.8 to 15.0 mm Hg, p <0.001), respectively. In this cohort, 9.4% had any bleeding complication noted during their hospital stay. One patients alteplase was prematurely discontinued for access site bleeding although no other interventions were required related to bleeding complications.

Association Between Public Reporting of Outcomes With Procedural Management and Mortality for Patients With Acute Myocardial Infarction

BACKGROUND Public reporting of procedural outcomes may create disincentives to provide percutaneous coronary intervention (PCI) for critically ill patients. OBJECTIVES This study evaluated the association between public reporting with procedural management and outcomes among patients with acute myocardial infarction (AMI). METHODS Using the Nationwide Inpatient Sample, we identified all patients with a primary diagnosis of AMI in states with public reporting (Massachusetts and New York) and regionally comparable states without public reporting (Connecticut, Maine, Maryland, New Hampshire, Rhode Island, and Vermont) between 2005 and 2011. Procedural management and in-hospital outcomes were stratified by public reporting. RESULTS Among 84,121 patients hospitalized with AMI, 57,629 (69%) underwent treatment in a public reporting state. After multivariate adjustment, percutaneous revascularization was performed less often in public reporting states than in nonreporting states (odds ratio [OR]: 0.81, 95% confidence interval [CI]: 0.67 to 0.96), especially among older patients (OR: 0.75, 95% CI: 0.62 to 0.91), those with Medicare insurance (OR: 0.75, 95% CI: 0.62 to 0.91), and those presenting with ST-segment elevation myocardial infarction (OR: 0.63, 95% CI: 0.56 to 0.71) or concomitant cardiac arrest or cardiogenic shock (OR: 0.58, 95% CI: 0.47 to 0.70). Overall, patients with AMI in public reporting states had higher adjusted in-hospital mortality rates (OR: 1.21, 95% CI: 1.06 to 1.37) than those in nonreporting states. This was observed predominantly in patients who did not receive percutaneous revascularization in public reporting states (adjusted OR: 1.30, 95% CI: 1.13 to 1.50), whereas those undergoing the procedure had lower mortality (OR: 0.71, 95% CI: 0.62 to 0.83). CONCLUSIONS Public reporting is associated with reduced percutaneous revascularization and increased in-hospital mortality among patients with AMI, particularly among patients not selected for PCI.

Protracted CRP Elevation after Atrial Fibrillation Ablation

Background: Atrial fibrillation (AF) has been linked to an inflammatory process detected through various biomarkers, including C‐Reactive Protein (CRP). Early recurrence of AF within the first 3 months after curative AF ablation is not felt to reflect success or failure of the procedure. We hypothesized that this early recurrence is due to an inflammatory response to the ablation itself. We therefore sought to evaluate levels of CRP after AF ablation.

Procedural failure of chronic total occlusion percutaneous coronary intervention: Insights from a multicenter US registry

The hybrid approach to chronic total occlusion (CTO) percutaneous coronary intervention (PCI) has significantly increased procedural success rates, yet some cases still fail. We sought to evaluate the causes of failure in a contemporary CTO PCI registry.

Percutaneous Intervention of Circumflex Chronic Total Occlusions Is Associated With Worse Procedural Outcomes: Insights From a Multicentre US Registry

BACKGROUND We sought to determine whether outcomes of chronic total occlusion (CTO) percutaneous coronary intervention (PCI) vary according to CTO target vessel: left anterior descending artery (LAD), left circumflex artery (LCX), and right coronary artery (RCA). METHODS We evaluated the clinical and angiographic characteristics and procedural outcomes of 636 patients who underwent CTO PCI at 6 high-volume centres in the United States between January 2012 and March 2014. RESULTS The CTO target vessel was the RCA in 387 cases (61%), LAD in 132 (21%), and LCX in 117 (18%). LCX lesions were more tortuous and RCA lesions had greater occlusion length and Japanese Chronic Total Occlusion (J-CTO) score, but were less likely to have a side branch at the proximal cap and had more developed collateral circulation. The rate of procedural success was lower in LCX CTOs (84.6%), followed by RCA (91.7%), and LAD (94.7%) CTOs (P = 0.016). Major complications tended to occur more frequently in LCX PCI (4.3% vs 1.0% for RCA vs 2.3% for LAD; P = 0.07). LCX and RCA CTO PCI required longer fluoroscopy times (45 [interquartile range (IQR), 30-74] minutes vs 45 [IQR, 21-69] minutes for RCA vs 34 [IQR, 20-60] minutes for LAD; P = 0.018) and LCX CTOs required more contrast administration (280 [IQR, 210-370] mL vs 250 [IQR, 184-350] mL for RCA and 280 [IQR, 200-400] mL for LAD). CONCLUSIONS In a contemporary, multicentre CTO PCI registry, LCX was the least common target vessel. Compared with LAD and RCA, PCI of LCX CTOs was associated with a lower rate of procedural success, less efficiency, and a nonsignificant trend for higher rates of complications.

Reporting Trends and Outcomes in ST-Segment–Elevation Myocardial Infarction National Hospital Quality Assessment Programs

Background— For patients who undergo primary percutaneous coronary intervention (PCI) for ST-segment–elevation myocardial infarction, the door-to-balloon time is an important performance measure reported to the Centers for Medicare & Medicaid Services (CMS) and tied to hospital quality assessment and reimbursement. We sought to assess the use and impact of exclusion criteria associated with the CMS measure of door-to-balloon time in primary PCI. Methods and Results— All primary PCI-eligible patients at 3 Massachusetts hospitals (Brigham and Women’s, Massachusetts General, and North Shore Medical Center) were evaluated for CMS reporting status. Rates of CMS reporting exclusion were the primary end points of interest. Key secondary end points were between-group differences in patient characteristics, door-to-balloon times, and 1-year mortality rates. From 2005 to 2011, 26% (408) of the 1548 primary PCI cases were excluded from CMS reporting. This percentage increased over the study period from 13.9% in 2005 to 36.7% in the first 3 quarters of 2011 (P<0.001). The most frequent cause of exclusion was for a diagnostic dilemma such as a nondiagnostic initial ECG, accounting for 31.2% of excluded patients. Although 95% of CMS-reported cases met door-to-balloon time goals in 2011, this was true of only 61% of CMS-excluded cases and consequently 82.6% of all primary PCI cases performed that year. The 1-year mortality for CMS-excluded patients was double that of CMS-included patients (13.5% versus 6.6%; P<0.001). Conclusions— More than a quarter of patients who underwent primary PCI were excluded from hospital quality reports collected by CMS, and this percentage has grown substantially over time. These findings may have significant implications for our understanding of process improvement in primary PCI and mechanisms for reimbursement through Medicare.

Treatment and Outcomes of Acute Myocardial Infarction Complicated by Shock After Public Reporting Policy Changes in New York.

IMPORTANCE In 2006, New York began excluding patients with cardiogenic shock from the publicly reported percutaneous coronary intervention (PCI) risk-adjusted mortality analyses. OBJECTIVE To examine the effects of the New York shock-exclusion policy change on rates of revascularization and mortality for patients with acute myocardial infarction (AMI) complicated by cardiogenic shock. DESIGN, SETTING, AND PARTICIPANTS This study used several comprehensive statewide hospitalization databases to identify patients with AMI and shock from January 1, 2002, through December 31, 2012, in New York and a series of comparator states (Massachusetts, Michigan, and New Jersey from January 1, 2002, through December 31, 2012, and California from January 1, 2003, through December 31, 2011). Data analysis was performed from October 1, 2015, to March 15, 2016. MAIN OUTCOMES AND MEASURES A difference-in-differences approach was used to evaluate whether the likelihood of receiving PCI and surviving to discharge differed after the policy change in New York in 2006 compared with comparator states that did not enact such a change. RESULTS Among 45 977 patients with AMI and cardiogenic shock (11 298 in New York), 21 974 (47.8%) underwent PCI. The mean (SD) age of the patients was 69.7 (13.2) years, and 18 139 (39.5%) were female. After adjusting for patient factors, patients in New York were significantly more likely to undergo PCI after the public reporting policy changes than they were previously (adjusted relative risk [aRR], 1.28; 95% CI, 1.19-1.37; P < .001) compared with a 9% increase in comparator states during the same period (aRR, 1.09; 95% CI, 1.05-1.13; P < .001; interaction P < .001). Nevertheless, rates of PCI remained lower in New York compared with comparator states throughout the study period. The adjusted risk of in-hospital death among patients in New York with AMI and shock decreased significantly faster after the policy change (aRR, 0.76; 95% CI, 0.72-0.81; P < .001) compared with comparator states (aRR, 0.91; 95% CI, 0.87-0.94; P < .001; interaction P < .001). CONCLUSIONS AND RELEVANCE The exclusion of patients with ongoing cardiogenic shock from New York PCI public reports in 2006 was associated with a significant increase in the use of PCI for cardiogenic shock and a concomitant decrease in in-hospital mortality, exceeding simultaneously observed trends in the comparator states. However, rates of PCI for AMI and shock were lower in New York throughout the study. Alterations in policies related to reporting mortality outcomes after cardiovascular procedures may have significant implications for physician behavior and the public health.

Comparison of Clinical Characteristics and Outcomes of Cardiac Arrest Survivors Having Versus Not Having Coronary Angiography

Prompt percutaneous coronary intervention is associated with improved survival in patients presenting with cardiac arrest. Few studies, however, have focused on patients with cardiac arrest not selected for coronary angiography. The aim of the present study was to evaluate the clinical characteristics and outcomes of patients with cardiac arrest denied emergent angiography. Patients with cardiac arrest were identified within a registry that included all catheterization laboratory activations from 2008 to 2012. Logistic regression and proportional-hazards models were created to assess the clinical characteristics and mortality associated with denying emergent angiography. Among 664 patients referred for catheterization, 110 (17%) had cardiac arrest, and 26 of these patients did not undergo emergent angiography. Most subjects (69%) were turned down for angiography for clinical reasons and a minority for perceived futility (27%). After multivariate adjustment, pulseless electrical activity as the initial arrest rhythm (adjusted odds ratio [AOR] 13.27, 95% confidence interval [CI] 1.76 to 100.12), <1.0 mm of ST-segment elevation (AOR 10.26, 95% CI 1.68 to 62.73), female gender (AOR 4.45, 95% CI 1.04 to 19.08), and advancing age (AOR 1.10 per year, 95% CI 1.04 to 1.16) were associated with increased odds of withholding angiography. The mortality rate was markedly higher for patients who were denied emergent angiography (hazard ratio 3.64, 95% CI 2.05 to 6.49), even after adjustment for medical acuity (hazard ratio 2.29, 95% CI 1.19 to 4.41). In conclusion, older subjects, women, and patients without ST-segment elevation were more commonly denied emergent angiography after cardiac arrest. Patients denied emergent angiography had increased mortality that persisted after adjustment for illness severity.

Optical Coherence Tomography

Case presentation : A 56-year-old man presented to the hospital with chest pain and a non–ST-segment elevation myocardial infarction. Thrombotic plaque rupture in the left anterior descending coronary artery was treated with an everolimus-eluting stent. After stent deployment, angiography demonstrated the presence of a hazy opacity at the distal edge of the stent, and there was concern about a possible edge dissection. Optical coherence tomography (OCT) imaging of the opacity showed residual thrombus and no dissection. Subsequent aspiration thrombectomy and balloon dilation effectively treated the lesion without deployment of an additional stent. OCT is an intravascular imaging modality that utilizes near-infrared light to generate cross-sectional blood vessel images. OCT is similar to intravascular ultrasound (IVUS), and both OCT and IVUS provide information about intravascular anatomy that far exceeds the level of detail obtained from conventional contrast cineangiography. With the use of light rather than ultrasound reflectance, OCT generates in vivo images of coronary arteries and deployed stents with up to 10 to 15 μm of spatial resolution compared with the 100- to 200-μm resolution of IVUS. Although the spatial resolution of OCT is markedly superior to that of IVUS, near-infrared light does not penetrate tissue as effectively as sound, and therefore OCT imaging depths range from 1 to 3 mm into the vessel wall, whereas IVUS imaging depths range from 4 to 10 mm (Table). Additionally, near-infrared light is scattered by red blood cells, and therefore OCT imaging requires transient blood clearing during image acquisition. View this table: Table. Comparison of FD-OCT and IVUS The speed of light was initially a central challenge to developing a “clinically friendly” OCT system. Light travels too quickly for direct measurement of differential reflectance caused by vascular structures, and the original time delay OCT (TD-OCT) systems utilized a moving reference mirror to calibrate reflected light waves for image …

Public reporting in cardiovascular medicine: accountability, unintended consequences, and promise for improvement.

“The Trustees of Hospitals should see to it,” wrote Dr Ernest Amory Codman in 1918, “that an effort is made to follow up each patient they treat, long enough to determine whether the treatment given has permanently relieved the condition or symptoms complained of.”1 These views did not help Dr Codman’s career. He quit his position as a staff surgeon at the Massachusetts General Hospital to protest the hospital administration’s refusal to measure and disclose outcomes and was later forced to resign as chairman of the Suffolk District Surgical Society.2 Two weeks after his death in 1940, the hospital’s trustees passed a resolution calling him a “champion of truth” who was “willing to sacrifice personal place and standing to achieve what he believed to be right.”2 In poor financial circumstances, he was buried initially without a headstone. In 2014, Dr Andrew L. Warshaw, the surgeon-in-chief emeritus and a former president of the New England Surgical Society, organized a granite and bronze memorial for Dr Codman’s gravesite in Cambridge, MA.2 More than 7 decades after Dr Codman’s death, debate persists about how to measure and report outcomes in medicine. Although the concept of measuring outcomes is now firmly embraced, risk-adjustment methods, the dissemination of outcomes data, and the incentives for healthcare providers and healthcare systems to improve outcomes remain contested. Cardiologists and cardiac surgeons have been among the first physicians to grapple with these issues, largely because cardiac disease is appealing for outcomes measurement and reporting. Not only is cardiac disease the leading cause of death in the United States, accounting for nearly one-fifth of healthcare spending,3 but the cardiovascular community has led the way in evidence-based guidelines that lend themselves to quality measurement. Globally, ischemic heart disease and stroke have become the top 2 causes …