Abstract Background Professional guidelines have reduced the recommended minimum number to an average of 50 percutaneous coronary intervention (PCI) procedures performed annually by each operator. ...Operator volume patterns and associated outcomes since this change are unknown. Objectives The authors describe herein PCI operator procedure volumes; characteristics of low-, intermediate-, and high-volume operators; and the relationship between operator volume and clinical outcomes in a large, contemporary, nationwide sample. Methods Using data from the National Cardiovascular Data Registry collected between July 1, 2009, and March 31, 2015, we examined operator annual PCI volume. We divided operators into low- (<50 PCIs per year), intermediate- (50 to 100 PCIs per year), and high- (>100 PCIs per year) volume groups, and determined the adjusted association between annual PCI volume and in-hospital outcomes, including mortality. Results The median annual number of procedures performed per operator was 59; 44% of operators performed <50 PCI procedures per year. Low-volume operators more frequently performed emergency and primary PCI procedures and practiced at hospitals with lower annual PCI volumes. Unadjusted in-hospital mortality was 1.86% for low-volume operators, 1.73% for intermediate-volume operators, and 1.48% for high-volume operators. The adjusted risk of in-hospital mortality was higher for PCI procedures performed by low- and intermediate-volume operators compared with those performed by high-volume operators (adjusted odds ratio: 1.16 for low versus high; adjusted odds ratio: 1.05 for intermediate vs. high volume) as was the risk for new dialysis post PCI. No volume relationship was observed for post-PCI bleeding. Conclusions Many PCI operators in the United States are performing fewer than the recommended number of PCI procedures annually. Although absolute risk differences are small and may be partially explained by unmeasured differences in case mix between operators, there remains an inverse relationship between PCI operator volume and in-hospital mortality that persisted in risk-adjusted analyses.
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 Cardiovascular disease (CVD) is a leading cause of death and disability in the United States. National quality programs such as the National Cardiovascular Data Registry (NCDR®) permit ...assessments of the quality of care and outcomes for broad populations of patients with CVD. This report provides data from 2014 from four NCDR® hospital quality programs: 1) CathPCI® for coronary angiography and percutaneous coronary intervention (667,424 procedures performed in 1,612 hospitals) ICD™ for implantable cardioverter defibrillators (158,649 procedures performed in 1,715 hospitals); 3) ACTION®-GWTG™ for acute coronary syndromes (182,903 patients admitted to 907 hospitals); and 4) IMPACT® for cardiac catheterization and intervention for pediatric and adult congenital heart disease (20,169 procedures in 76 hospitals). The report provides perspectives on the demographic and clinical characteristics of enrolled patients; characteristics of participating centers; selected measures of processes and outcomes of care.
Women are at higher risk than men for bleeding and vascular complications after percutaneous coronary intervention (PCI). Compared with femoral access, radial access reduces these complications but ...may be more challenging in women because of higher rates of radial artery spasm, tortuosity, and occlusion as well as lower rates of procedure success. Whether the safety advantages of radial versus femoral access in women undergoing PCI are outweighed by reduced effectiveness has not been studied. The Study of Access site For Enhancement of PCI for Women is a prospective, randomized clinical trial comparing radial with femoral arterial access in women undergoing PCI. In conjunction with the US Food and Drug Administration's Critical Path Cardiac Safety Research Consortium, this study embeds the randomized clinical trial into the existing infrastructure of the National Cardiovascular Data Registry™ CathPCI Registry™ through the National Institute of Health's National Cardiovascular Research Infrastructure. The primary efficacy end point is a composite of bleeding (Bleeding Academic Research Consortium types 2, 3, or 5) or vascular complication requiring intervention occurring at 72 hours after PCI or by hospital discharge. The primary feasibility end point is procedure success. Secondary end points include procedure duration, contrast volume, radiation dose, quality of life, and a composite of 30-day death, vascular complication, or unplanned revascularization.
Summary The National Cardiovascular Data Registries (NCDR) of the American College of Cardiology consists of ten national programs designed to measure quality of care for high impact cardiovascular ...conditions and procedures. The NCDR provides feedback with benchmarking of a broad range of quality metrics to participants; supports quality improvement interventions at the local and national level; and serves as the basis for cardiovascular health services and epidemiology research that informs contemporary clinical care. This report provides a summary of key findings from four established hospital programs: CathPCI Registry (capturing data on coronary angiography and percutaneous coronary interventions); ACTION-GWTG (acute myocardial infarction) the ICD Registry (implantable cardioverter defibrillators and cardiac resynchronization therapy); and the IMPACT Registry (catheterization procedures for congenital heart disease in children and adults). A more complete report is published separately.Ref complete data report Data from the ambulatory programs and those focusing on newly adopted technologies will be reported separately or will be included in future reports. The data provided reflect care in 2014 and in some cases include temporal trends since 2011. NCDR data provide a unique, clinically rich national perspective on the care and outcomes of high-impact cardiovascular conditions and procedures that are not available elsewhere.
Background In the SAFE-PCI for Women trial, patient preference for radial access for future procedures was greater than for femoral access. We sought to assess whether radial or femoral access ...impacts formal measures of quality-of-life (QOL) among women undergoing cardiac catheterization. Methods We assessed QOL using European quality of life–5 dimensions (EQ-5D) and EQ visual analog scale (EQ-VAS) scores among 304 women randomized to radial or femoral arteriotomy in the SAFE-PCI for Women trial at sites with QOL substudy approval. Patient surveys were administered at baseline, hospital discharge, and 30 days (for percutaneous coronary intervention patients). Results Women randomized to both treatments had similar EQ-5D index and EQ-VAS scores at baseline, hospital discharge, and 30-day follow-up. After adjustment for baseline scores, there was no effect of assigned treatment on EQ-5D (discharge 0.004; 95% CI −0.03 to 0.04; 30 days −0.03; 95% CI −0.09 to 0.02) or EQ-VAS (discharge −1.31; 95% CI −4.74 to 2.12; 30 days −2.10; 95% CI −8.92 to 4.71) scores. At discharge, 60.5% versus 63.5% ( P = .60) of patients in radial and femoral groups were free from access site pain; at 30 days, rates were 85.7% versus 77.6% ( P = .30), respectively. Patient preference for the same access strategy for repeat procedures was greater in the radial versus femoral group (77.2% vs 26.8%; P < .0001). Conclusions Using established QOL instruments, we did not measure any difference in QOL or functional status according to access site strategy in women undergoing cardiac catheterization, yet patient preference for the radial approach was significantly greater. Other factors influencing patient choice for radial access should be investigated.
Objectives This study sought to examine the contemporary incidence, predictors and outcomes of acute kidney injury in patients undergoing percutaneous coronary interventions. Background Acute kidney ...injury (AKI) is a serious and potentially preventable complication of percutaneous coronary interventions (PCIs) that is associated with adverse outcomes. The contemporary incidence, predictors, and outcomes of AKI are not well defined, and clarifying these can help identify high-risk patients for proactive prevention. Methods A total of 985,737 consecutive patients underwent PCIs at 1,253 sites participating in the National Cardiovascular Data Registry Cath-PCI registry from June 2009 through June 2011. AKI was defined on the basis of changes in serum creatinine level in the hospital according to the Acute Kidney Injury Network (AKIN) criteria. Using multivariable regression analyses with generalized estimating equations, we identified patient characteristics associated with AKI. Results Overall, 69,658 (7.1%) patients experienced AKI, with 3,005 (0.3%) requiring new dialysis. On multivariable analyses, the factors most strongly associated with development of AKI included ST-segment elevation myocardial infarction (STEMI) presentation (odds ratio OR: 2.60; 95% confidence interval CI: 2.53 to 2.67), severe chronic kidney disease (OR: 3.59; 95% CI: 3.47 to 3.71), and cardiogenic shock (OR: 2.92; 95% CI: 2.80 to 3.04). The in-hospital mortality rate was 9.7% for patients with AKI and 34% for those requiring dialysis compared with 0.5% for patients without AKI (p < 0.001). After multivariable adjustment, AKI (OR: 7.8; 95% CI: 7.4 to 8.1, p < 0.001) and dialysis (OR: 21.7; 95% CI: 19.6 to 24.1; p < 0.001) remained independent predictors of in-hospital mortality. Conclusions Approximately 7% of patients undergoing a PCI experience AKI, which is strongly associated with in-hospital mortality. Defining strategies to minimize the risk of AKI in patients undergoing PCI are needed to improve the safety and outcomes of the procedure.
Background Cardiac allograft vasculopathy is a major cause of morbidity and mortality following heart transplantation. Large multicenter studies evaluating the clinical characteristics and inhospital ...outcomes of heart transplant recipients undergoing percutaneous coronary intervention (PCI) are lacking. Objective To evaluate the clinical characteristics, treatment patterns and inhospital outcomes of heart transplant recipients undergoing PCI compared to general population. Methods We analyzed 1,897,328 patients from the National Cardiovascular Data Registry CathPCI registry who underwent PCI of at least 1 native vessel between July 2009 and December 2013 from 1,477 centers, of which 542 patients (0.03%) were heart transplant recipients. Clinical characteristics were evaluated and, after 1:4 propensity matching, inhospital outcomes were compared between 538 heart transplant patients and 2,128 non-transplant patients. Results Transplant recipients undergoing PCI had a higher prevalence of diabetes, dyslipidemia and peripheral vascular disease; lower prevalence of angina, acute coronary syndrome, abnormal noninvasive functional study, and type C coronary lesions compared to the non-transplant PCI population. After propensity matching, all-cause inhospital mortality was similar between transplant and non-transplant groups (1.3% vs 1.0%; OR, 1.21; 95% CI, 0.54-2.67). Conclusion This is the largest series to date outlining the characteristics of heart transplant recipients undergoing PCI. Similar inhospital outcomes were noted in heart transplant recipients compared to the general population. Further studies evaluating long-term outcomes are warranted.
Summary Background Recent reductions in average door-to-balloon (D2B) times have not been associated with decreases in mortality at the population level. We investigated this seemingly paradoxical ...finding by assessing components of this association at the individual and population levels simultaneously. We postulated that the changing population of patients undergoing primary percutaneous coronary intervention (pPCI) contributed to secular trends toward an increasing mortality risk, despite consistently decreased mortality in individual patients with shorter D2B times. Methods This was a retrospective study of ST-elevation myocardial infarction (STEMI) patients who underwent pPCI between Jan 1, 2005, and Dec 31, 2011, in the National Cardiovascular Data Registry (NCDR) CathPCI Registry. We looked for catheterisation laboratory visits associated with STEMI. We excluded patients not undergoing pPCI, transfer patients for pPCI, patients with D2B times less than 15 min or more than 3 h, and patients at hospitals that did not consistently report data across the study period. We assessed in-hospital mortality in the entire cohort and 6-month mortality in elderly patients aged 65 years or older matched to data from the Centers for Medicare and Medicaid Services. We built multilevel models to assess the relation between D2B time and in-hospital and 6-month mortality, including both individual and population-level components of this association after adjusting for patient and procedural factors. Findings 423 hospitals reported data on 150 116 procedures with a 55% increase in the number of patients undergoing pPCI at these facilities over time, as well as many changes in patient and procedural factors. Annual D2B times decreased significantly from a median of 86 min (IQR 65–109) in 2005 to 63 min (IQR 47–80) in 2011 (p<0·0001) with a concurrent rise in risk-adjusted in-hospital mortality (from 4·7% to 5·3%; p=0·06) and risk-adjusted 6-month mortality (from 12·9% to 14·4%; p=0·001). In multilevel models, shorter patient-specific D2B times were consistently associated at the individual level with lower in-hospital mortality (adjusted OR for each 10 min decrease 0·92; 95% CI 0·91–0·93; p<0·0001) and 6-month mortality (adjusted OR for each 10 min decrease, 0·94; 95% CI 0·93–0·95; p<0·0001). By contrast, risk-adjusted in-hospital and 6-month mortality at the population level, independent of patient-specific D2B times, rose in the growing and changing population of patients undergoing pPCI during the study period. Interpretation Shorter patient-specific D2B times were consistently associated with lower mortality over time, whereas secular trends suggest increased mortality risk in the growing and changing pPCI population. The absence of association of annual D2B time and changes in mortality at the population level should not be interpreted as an indication of its individual-level relation in patients with STEMI undergoing primary PCI. Funding National Heart, Lung, and Blood Institute.
In our study, patients who did not have a follow-up outpatient appointment arranged before discharge were less likely to report their bleeding event to a clinician. ...ensuring early clinical ...follow-up--particularly for patients at higher risk of bleeding (e.g., women, lower baseline functional status, discharge on a second-generation ADPri regimen, or concurrent oral anticoagulant prescription)--might be a key first step in both raising subsequent bleeding events to clinical attention and avoiding premature ADPri discontinuation. ...bleeding occurs commonly in the early period after discharge among MI patients treated with PCI and ADPris and is not always brought to clinical attention.
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