Clinical and health status outcomes among patients treated with single as compared to multivessel angioplasty during chronic total occlusion percutaneous coronary interventions: a report from the OPEN CTO registry.

BACKGROUND: Patients with coronary chronic total occlusions (CTO) often have multivessel coronary artery disease. We utilized the OPEN CTO study to evaluate patients who underwent single-vessel versus multivessel percutaneous coronary intervention (PCI) during CTO PCI. METHODS: Patients were considered to have undergone single-vessel CTO PCI if they underwent target-vessel only CTO PCI. Patients who underwent multivessel PCI during their index CTO PCI procedure were considered to have undergone multivessel PCI. The additional lesions treated in the multivessel group could be either a separate CTO lesion in a separate epicardial vessel or PCI attempt of any non-CTO stenosis during the same index procedure. Multivariate regression models were used to evaluate predictors of technical success, in-hospital major adverse cardiac and cerebrovascular events (MACCE), and health status measures. RESULTS: Eighty hundred twenty-one patients underwent single-vessel CTO PCI and 179 (17.9%) underwent multivessel PCI during their CTO PCI procedure. Baseline comorbidities, index CTO lesion complexity, and successful crossing strategies used were similar between the two groups. Total procedural time (142.6 versus 115.9 minutes, P < 0.01) and contrast administered (293.8 versus 255.0 ml, P < 0.01) were increased in the multivessel CTO PCI group. Single-vessel versus multivessel PCI during these cases did not affect the likelihood of achieving technical success [odds ratio (OR) 1.05, 95% confidence interval (CI) 0.63-1.75] nor the risk for MACCE (OR 1.23, 95% CI 0.72-2.11). Quality of life (QOL) metrics were similar between the two groups at baseline and 30-day follow-up. CONCLUSION: There were no significant differences in technical success, in-hospital MACCE rates, or QOL metrics at 30-day follow-up for patients who underwent single-vessel versus multivessel PCI during CTO PCI.

Association Between 90-Minute Door-to-Balloon Time, Selective Exclusion of Myocardial Infarction Cases, and Access Site Choice: Insights From the Cardiac Care Outcomes Assessment Program (COAP) in Washington State.

BACKGROUND: For patients presenting with ST-segment-elevation myocardial infarction, national quality initiatives monitor hospitals' proportion of cases with door-to-balloon (D2B) time under 90 minutes. Hospitals are allowed to exclude patients from reporting and may modify behavior to improve performance. We sought to identify whether there is a discontinuity in the number of cases included in the D2B time metric at 90 minutes and whether operators were increasingly likely to pursue femoral access in patients with less time to meet the 90-minute quality metric. METHODS: Adult patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention from 2011 to 2018 were identified from the Cardiac Care Outcomes Assessment Program, a quality improvement registry in Washington state. We used the regression discontinuity framework to test for discontinuity at 90 minutes among the included cases. We defined a novel variable, remaining D2B as 90 minutes minus the time between hospital arrival and catheterization laboratory arrival. We estimated multivariable logistic regression models to assess the relationship between remaining D2B time and access site. RESULTS: A total of 19 348 patients underwent primary percutaneous coronary intervention and were included in the analysis. Overall, 7436 (38.4%) were excluded from the metric. There appeared to be a visual discontinuity in included cases around 90 minutes; however, local quadratic regression around the 90-minute cutoff did not reveal evidence of a significant discontinuity (P=0.66). Multivariable analysis showed no significant relationship between remaining D2B time and the odds of undergoing femoral access (P=0.73). CONCLUSIONS: Among patients undergoing percutaneous coronary intervention for ST-segment-elevation myocardial infarction, we did not find evidence of a statistically significant discontinuity in the frequency of included cases around 90 minutes or an increased preference for femoral access correlated with decreasing time to meet the 90-minute D2B time quality metric. Together, these findings indicate no evidence of widespread inappropriate methods to improve performance on D2B time metrics.

Temporal Trends in Percutaneous Coronary Intervention and Coronary Artery Bypass Grafting: Insights From the Washington Cardiac Care Outcomes Assessment Program.

Background Patient selection and outcomes for percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) have changed over the past decade. However, there is limited information on outcomes for both revascularization strategies in the same population. The study evaluated temporal changes in risk profile, procedural characteristics, and clinical outcomes for PCI- and CABG-treated patients. Methods and Results We analyzed all PCI and isolated CABG between 2005 and 2017 in nonfederal hospitals in Washington State. Descriptive analysis was performed to evaluate temporal changes in risk profile and, risk-adjusted in-hospital mortality. Over the study period, 178 474 PCI and 36 592 CABG procedures were performed. PCI and CABG volume decreased by 2.9% and 22.6%, respectively. Compared with 2005-2009, patients receiving either form of revascularization between 2014 and 2017 had a higher prevalence of comorbidities including diabetes mellitus and hypertension and dialysis. Presentation with ST-segment-elevation myocardial infarction (17% versus 20%) and cardiogenic shock (2.4% versus 3.4%) increased for patients with PCI compared with CABG. Conversely, clinical acuity decreased for patients receiving CABG over the study period. From 2005 to 2017, mean National Cardiovascular Data Registry CathPCI mortality score increased for patients treated with PCI (20.1 versus 22.4, P<0.0001) and decreased for patients treated with CABG (18.8 versus 17.8, P<0.0001). Adjusted observed/expected in-hospital mortality ratio increased for PCI (0.98 versus 1.19, P<0.0001) but decreased for CABG (1.21 versus 0.74, P<0.0001) over the study period. Conclusions Clinical acuity increased for patients treated with PCI rather than CABG. This resulted in an increase in adjusted observed/expected mortality ratio for patients undergoing PCI and a decrease for CABG. These shifts may reflect an increased use of PCI instead of CABG for patients considered to be at high surgical risk.

Randomized Comparison of a CrossBoss First Versus Standard Wire Escalation Strategy for Crossing Coronary Chronic Total Occlusions: The CrossBoss First Trial.

OBJECTIVES: The authors performed a multicenter, randomized-controlled, clinical trial comparing upfront use of the CrossBoss catheter versus antegrade wire escalation for antegrade crossing of coronary chronic total occlusions. BACKGROUND: There is equipoise about the optimal initial strategy for crossing coronary chronic total occlusions. METHODS: The primary endpoints were the time required to cross the chronic total occlusion or abort the procedure and the frequency of procedural major adverse cardiovascular events. The secondary endpoints were technical and procedural success, total procedure time, fluoroscopy time required to cross and total fluoroscopy time, total air kerma radiation dose, total contrast volume, and equipment use. RESULTS: Between 2015 and 2017, 246 patients were randomized to the CrossBoss catheter (n = 122) or wire escalation (n = 124) at 11 U.S. centers. The baseline clinical and angiographic characteristics of the study groups were similar. Technical and procedural success were 87.8% and 84.1%, respectively, and were similar in the 2 groups. Crossing time was similar: 56 min (interquartile range: 33 to 93 min) in the CrossBoss group and 66 min (interquartile range: 36 to 105 min) in the wire escalation group (p = 0.323), as was as the incidence of procedural major adverse cardiovascular events (3.28% vs. 4.03%; p = 1.000). There were no significant differences in the secondary study endpoints. CONCLUSIONS: As compared with wire escalation, upfront use of the CrossBoss catheter for antegrade crossing of coronary chronic total occlusions was associated with similar crossing time, similar success and complication rates, and similar equipment use and cost.

Referral to Cardiac Rehabilitation After Percutaneous Coronary Intervention, Coronary Artery Bypass Surgery, and Valve Surgery: Data From the Clinical Outcomes Assessment Program.

BACKGROUND: Despite guideline recommendations that patients undergoing percutaneous coronary intervention (PCI), coronary artery bypass surgery, or valve surgery be referred to cardiac rehabilitation, cardiac rehabilitation is underused. The objective of this study was to examine hospital-level variation in cardiac rehabilitation referral after PCI, coronary artery bypass surgery, and valve surgery. METHODS AND RESULTS: We analyzed data from the Clinical Outcomes Assessment Program, a registry of all nonfederal hospitals performing PCI and cardiac surgery in Washington State. We included eligible PCI, coronary artery bypass surgery, and valve surgery patients from 2010 to 2015. We analyzed PCI and cardiac surgery separately by performing multivariable hierarchical logistic regression for the outcome of cardiac rehabilitation referral at discharge, clustered by hospital. Patient-level covariates included age, sex, race/ethnicity, comorbidities, and procedure indication/status. Cardiac rehabilitation referral was reported in 48% (34 047/71 556) of PCI patients and 91% (21 831/23 972) of cardiac surgery patients. The hospital performing the procedure was a stronger predictor of referral than any individual patient characteristic for PCI (hospital referral range 3%-97%; median odds ratio, 5.94; 95% confidence interval, 4.10-9.49) and cardiac surgery (range 54%-100%; median odds ratio, 7.09; 95% confidence interval, 3.79-17.80). Hospitals having an outpatient cardiac rehabilitation program explained only 10% of PCI variation and 0% of cardiac surgery variation. CONCLUSIONS: Cardiac rehabilitation referral at discharge was less prevalent after PCI than cardiac surgery. The strongest predictor of cardiac rehabilitation referral was the hospital performing the procedure. Efforts to improve cardiac rehabilitation referral should focus on increasing referral after PCI, especially in low referral hospitals.

Management of Patients With Cardiac Arrest Complicating Myocardial Infarction in New York Before and After Public Reporting Policy Changes.

BACKGROUND: In 2010, New York State began excluding selected patients with cardiac arrest and coma from publicly reported mortality statistics after percutaneous coronary intervention. We evaluated the effects of this exclusion on rates of coronary angiography, revascularization, and mortality among patients with acute myocardial infarction and cardiac arrest. METHODS AND RESULTS: Using statewide hospitalization files, we identified discharges for acute myocardial infarction and cardiac arrest January 2003 to December 2013 in New York and several comparator states. A difference-in-differences approach was used to evaluate the likelihood of coronary angiography, revascularization, and in-hospital mortality before and after 2010. A total of 26 379 patients with acute myocardial infarction and cardiac arrest (5619 in New York) were included. Of these, 17 141 (65%) underwent coronary angiography, 12 183 (46.2%) underwent percutaneous coronary intervention, and 2832 (10.7%) underwent coronary artery bypass grafting. Before 2010, patients with cardiac arrest in New York were less likely to undergo percutaneous coronary intervention compared with referent states (adjusted relative risk, 0.79; 95% confidence interval, 0.73-0.85; P<0.001). This relationship was unchanged after the policy change (adjusted relative risk, 0.82; 95% confidence interval, 0.76-0.89; interaction P=0.359). Adjusted risks of in-hospital mortality between New York and comparator states after 2010 were also similar (adjusted relative risk, 0.94; 95% confidence interval, 0.87-1.02; P=0.152 for post- versus pre-2010 in New York; adjusted relative risk, 0.88; 95% confidence interval, 0.84-0.92; P<0.001 for comparator states; interaction P=0.103). CONCLUSIONS: Exclusion of selected cardiac arrest cases from public reporting was not associated with changes in rates of percutaneous coronary intervention or in-hospital mortality in New York. Rates of revascularization in New York for cardiac arrest patients were lower throughout.

Temporal Trends in Percutaneous Coronary Intervention Appropriateness: Insights From the Clinical Outcomes Assessment Program.

BACKGROUND: It is unknown whether the appropriate use of percutaneous coronary intervention (PCI) has improved over time and whether trends in PCI appropriateness have been accompanied by changes in the use of PCI. METHODS AND RESULTS: We applied appropriate use criteria to determine the appropriateness of all 51 872 PCI performed in Washington State from 2010 through 2013. We evaluated the number of PCIs performed from 2006 through 2013 to provide a comparator period that preceded statewide appropriateness assessment beginning in 2010. Between 2010 and 2013, the overall number of PCI decreased by 6.8% (13 267 PCIs in 2010 to 12 193 in 2013) with a 43% decline in the number of PCIs for elective indications (3818 PCIs in 2010 to 2193 PCIs in 2013). The decline in the use of elective PCI was significantly larger after the onset of statewide PCI appropriateness assessment in 2010 (P=0.03). The proportion of elective PCIs classified as appropriate increased from 26% in 2010 to 38% in 2013, whereas the proportion of inappropriate PCIs decreased from 16% to 13% (P<0.001 for trends). Significant improvements in the proportion of inappropriate PCI were limited to the tertile of hospitals with the largest decline in PCIs classified as inappropriate (25% in 2010 to 12% in 2013; P=0.03). CONCLUSIONS: In Washington State, the use of PCI for elective indications has decreased over time with concurrent improvements in PCI appropriateness. However, improvements in PCI appropriateness were limited to a minority of hospitals. Understanding processes at these high-performing hospitals may inform efforts to improve PCI appropriateness.

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.

Long-term outcomes of patients sent emergently to the catheterization laboratory for possible primary percutaneous coronary intervention.

Current guidelines advocate primary percutaneous coronary intervention as the therapy of choice for ST-segment elevation myocardial infarction (STEMI) when available. Little is known about the outcomes of patients without a culprit lesion after referral for primary percutaneous coronary intervention for a presumed STEMI. Subjects were identified within a registry containing consecutive patients who underwent emergent angiography for a potential STEMI from October 2008 to July 2012. Vital status was obtained from the medical record and Social Security Death Index. Cox proportional hazards models were created to evaluate the relation between the angiographic findings and cardiovascular outcomes, including major adverse cardiovascular events (MACE) and mortality. Among 539 patients who underwent emergent angiography, 65 (12%) had no coronary artery disease (CAD), 110 (20%) had CAD without a culprit lesion, and 364 (68%) had a culprit lesion. Kaplan-Meier analysis of MACE demonstrated that patients with CAD who lack a culprit lesion had a similar rate of MACE to those with a culprit lesion (p = 0.64), and both groups had significantly increased risk compared with those with no CAD (hazard ratio [HR] 1.9, 95% confidence interval [CI] 1.01 to 3.41 and HR 2.0, 95% CI 1.15 to 3.54, respectively). Kaplan-Meier analysis of mortality illustrated a nonsignificant trend toward increased mortality in patients having a culprit lesion (HR 1.7, 95% CI 0.59 to 4.80) and those having CAD without a culprit lesion (HR 1.2, 95% CI 0.39 to 3.81) compared with those with no CAD. In conclusion, patients found to have CAD without a culprit lesion in emergent angiography after a presumptive STEMI diagnosis have similar long-term rates of MACE compared with those requiring emergent revascularization.