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).
Background Guidelines recommend noninvasive tests (NITs) to risk stratify and identify patients with higher likelihood of coronary artery disease (CAD) prior to elective coronary angiography. ...However, a high percentage of patients are found to have nonobstructive CAD. We aimed to understand the relationship between patient characteristics, NIT findings, and the likelihood of nonobstructive CAD. Methods Patients undergoing elective catheterization without history of CAD were identified from 1,128 hospitals in National Cardiovascular Data Registry's CathPCI Registry between July 2009 and December 2011. Noninvasive tests included stress electrocardiogram, stress echocardiogram, stress radionuclide, stress cardiac magnetic resonance, and computed tomographic angiography. Patient demographics, risk factors, symptoms, and NIT results were correlated with the presence of nonobstructive CAD , defined as all native coronary stenoses <50%. Results Of 661,063 patients undergoing elective angiography, 386,003 (58.4%) had nonobstructive CAD. Preprocedure NIT was performed in 64% of patients; 51.9% were reported to be abnormal, but only 9% had high-risk findings. Independent factors associated with nonobstructive CAD were younger age, female sex, atypical chest pain, and a low-risk NIT. Patients with high-risk findings on NIT were more likely to have obstructive CAD (adjusted odds ratio 3.03 2.86-3.22). Noninvasive test findings had minimal incremental value beyond clinical factors for predicting obstructive disease ( C index = 0.75 for clinical factors vs 0.74 for NIT findings). Conclusion In current practice, about two-thirds of patients undergo NIT prior to elective cardiac catheterization, yet most patients have nonobstructive CAD. The weak correlation between most NIT results and the likelihood of obstructive CAD provides further impetus for improving preangiography assessment of likelihood of disease.
Background Lipid levels among contemporary patients hospitalized with coronary artery disease (CAD) have not been well studied. This study aimed to analyze admission lipid levels in a broad ...contemporary population of patients hospitalized with CAD. Methods The Get With The Guidelines database was analyzed for CAD hospitalizations from 2000 to 2006 with documented lipid levels in the first 24 hours of admission. Patients were divided into low-density lipoprotein cholesterol (LDL), high-density lipoprotein cholesterol (HDL), and triglyceride categories. Factors associated with LDL and HDL levels were assessed along with temporal trends. Results Of 231,986 hospitalizations from 541 hospitals, admission lipid levels were documented in 136,905 (59.0%). Mean lipid levels were LDL 104.9 ± 39.8, HDL 39.7 ± 13.2, and triglyceride 161 ± 128 mg/dL. Low-density lipoprotein cholesterol <70 mg/dL was observed in 17.6% and ideal levels (LDL <70 with HDL ≥60 mg/dL) in only 1.4%. High-density lipoprotein cholesterol was <40 mg/dL in 54.6% of patients. Before admission, only 28,944 (21.1%) patients were receiving lipid-lowering medications. Predictors for higher LDL included female gender, no diabetes, history of hyperlipidemia, no prior lipid-lowering medications, and presenting with acute coronary syndrome. Both LDL and HDL levels declined over time ( P < .0001). Conclusions In a large cohort of patients hospitalized with CAD, almost half have admission LDL levels <100 mg/dL. More than half the patients have admission HDL levels <40 mg/dL, whereas <10% have HDL ≥60 mg/dL. These findings may provide further support for recent guideline revisions with even lower LDL goals and for developing effective treatments to raise HDL.
Background Black and Hispanic populations are at increased risk for developing heart failure (HF) at a younger age and experience differential morbidity and possibly differential mortality compared ...with whites. Yet, there have been insufficient data characterizing the clinical presentation, quality of care, and outcomes of patients hospitalized with HF as a function of race/ethnicity. Methods We analyzed 78,801 patients from 257 hospitals voluntarily participating in the American Heart Association's Get With The Guidelines–HF Program from January 2005 thru December 2008. There were 56,266 (71.4%) white, 17,775 (22.6%) black, and 4,760 (6.0%) Hispanic patients. In patients hospitalized with HF, we sought to assess clinical characteristics, adherence to core and other guideline-based HF care measures, and in-hospital mortality as a function of race and ethnicity. Results Relative to white patients, Hispanic and black patients were significantly younger (median age 78.0, 63.0, 64.0 years, respectively), had lower left ventricular ejection fractions, and had more diabetes mellitus and hypertension. With few exceptions, the provision of guideline-based care was comparable for black, Hispanic, and white patients. Black and Hispanic patients had lower in-hospital mortality than white patients: black/white odds ratio 0.69, 95% CI 0.62-0.78, P < .001 and Hispanic/white odds ratio 0.81, 95% CI 0.67-0.98, P = .03. Conclusions Hispanic and black patients hospitalized with HF have more cardiovascular risk factors than white patients; however; they have similar or better in-hospital mortality rates. Within the context of a national HF quality improvement program, HF care was equitable and improved in all racial/ethnic groups over time.
Background When transcatheter aortic valve replacement (TAVR) cannot be carried out through transfemoral access, alternative access TAVR is indicated. The purpose of this study was to explore ...inhospital and 1-year outcomes of patients undergoing alternative access TAVR through the transapical (TA) or transaortic (TAo) techniques in the United States. Methods Clinical records of 4,953 patients undergoing TA (n = 4,085) or TAo (n = 868) TAVR from 2011 to 2014 in The Society of Thoracic Surgeons (STS)/American College of Cardiology Transcatheter Valve Therapy Registry were linked to Centers for Medicare and Medicaid Services hospital claims. Inhospital and 1-year clinical outcomes were stratified by operative risk; and the risk-adjusted association between access route and mortality, stroke, and heart failure repeat hospitalization was explored. Results Mean age for all patients was 82.8 ± 6.8 years. The median STS predicted risk of mortality was significantly higher among patients undergoing TAo (8.8 versus 7.4, p < 0.001). When compared with TA, TAo was associated with an increased risk of unadjusted 30-day mortality (10.3% versus 8.8%) and 1-year mortality (30.3% versus 25.6%, p = 0.006). There were no significant differences between TAo and TA for inhospital stroke rate (2.2%), major vascular complications (0.3%), and 1-year heart failure rehospitalizations (15.7%). Examination of high-risk and inoperable subgroups showed that 1-year mortality was significantly higher for TAo patients classified as inoperable ( p = 0.012). Conclusions Patients undergoing TAo TAVR are older, more likely female, and have significantly higher STS predicted risk of mortality scores than patients operated on by TA access. There were no risk-adjusted differences between TA and TAo access in mortality, stroke, or readmission rates as long as 1 year after TAVR.
Background Black individuals eligible for an implantable cardioverter/defibrillator (ICD) are considerably less likely than white individuals to receive one. This disparity may, in part, be explained ...by racial differences in patient preferences. We hypothesized that a targeted patient-centered educational video could improve knowledge of sudden cardiac arrest (SCA) and ICDs and reduce racial differences in ICD preferences. We conducted a pilot study to assess the feasibility of testing this hypothesis in a randomized trial. Methods We created a video that included animation, physician commentary, and patient testimonials on SCA and ICDs. The primary outcome was the decision to have an ICD implanted as a function of race and intervention. Between January 1, 2011, and December 31, 2011, 59 patients (37 white and 22 black) were randomized to the video or health care provider counseling/usual care. Results Relative to white patients, black patients were younger (median age, 55 vs 68 years) and more likely to have attended college or technical school. Baseline SCA and ICD knowledge was similar and improved significantly in both racial groups after the intervention. Black patients viewing the video were as likely as white patients to want an ICD (60.0% vs 79.2%, P = .20); and among those in the usual care arm, black patients were less likely than white patients to want an ICD (42.9% vs 84.6% P = .05). Conclusion Among individuals eligible for an ICD, a video decision aid increased patient knowledge and reduced racial differences in patient preference for an ICD.
Abstract Objectives The goal of this study was to examine the calibration of a validated risk-adjustment model in very high-risk percutaneous coronary intervention (PCI) cases and assess whether ...sites' case mix affects their performance ratings. Background There are concerns that treating PCI patients with particularly high-risk features such as cardiogenic shock or prior cardiac arrest may adversely impact hospital performance ratings. However, there is little investigation on the validity of these concerns. Methods We examined 624,286 PCI procedures from 1,168 sites that participated in the CathPCI Registry in 2010. Procedural risk was estimated using the recently published Version 4 National Cardiovascular Data Registry (NCDR) PCI risk-adjusted mortality (RAM) model. We calculated observed/expected mortality using several risk classification methods, and simulated hospital performance after combining their highest risk cases over 2 years into a single year. Results In 2010, crude in-hospital PCI mortality was 1.4%. The NCDR model was generally well calibrated among high risk, however there was slight overprediction of risk in extreme cases. Hospitals treating the highest overall expected risk PCI patients or those treating the top 20% of high-risk cases had lower (better) RAM ratings than centers treating lower-risk cases (1.25% vs. 1.51%). The observed/expected ratio for top-risk quintile versus low-risk quintile was 0.91 (0.87 to 0.96) versus 1.10 (1.03 to 1.17). Combining all the high-risk patients over a 2-year period into a single year also did not negatively impact the site's RAM ratings. Conclusions Evaluation of a contemporary sample of PCI cases across the United States showed no evidence that treating high-risk PCI cases adversely affects hospital RAM rates.
Objectives The authors sought to describe the association between post-procedural bleeding and long-term recurrent bleeding, major adverse cardiac events (MACE), and mortality among older patients ...undergoing percutaneous coronary intervention (PCI). Background Bleeding complications after PCI are associated with an increased risk for acute morbidity and long-term mortality, but the association of these bleeding complications with other events is unknown. Methods Patients entered into the National Cardiovascular Data Registry (NCDR) CathPCI Registry (n = 461,311; 946 sites) from January 2004 to December 2008 were linked with claims from the Centers for Medicare & Medicaid Services and grouped according to in-hospital post-PCI bleeding. The association between post-PCI bleeding and 1-, 12-, and 30-month readmission for bleeding, MACE, and all-cause mortality was examined with Cox regression that included patient and procedural characteristics using no bleeding as the reference. Results Overall, 3.1% (n = 14,107) of patients experienced post-PCI bleeding. Patients who bled were older, more often female, had more medical comorbidities, less often received bivalirudin, and more often underwent PCI via the femoral approach. After adjustment, bleeding after the index procedure was significantly associated with readmission for bleeding (adjusted hazard ratios 95% confidence interval: 1 month, 1.54 1.42 to 1.67; 12 months, 1.52 1.40 to 1.66; 30 months, 1.29 1.11 to 1.50), MACE (1 month, 1.11 1.07 to 1.15; 12 months, 1.17 1.13 to 1.21; 30 months, 1.12 1.06 to 1.19) and all-cause mortality (1 month, 1.32 1.26 to 1.38; 12 months, 1.33 1.27 to 1.40); 30 months, 1.22 1.15 to 1.30). Conclusions Post-PCI bleeding complications are associated with an increased risk for short- and long-term recurrent bleeding, MACE, and all-cause mortality. These data underscore the prognostic importance of periprocedural bleeding and the need for identifying strategies to reduce long-term bleeding risk among patients undergoing PCI.
Background New percutaneous coronary intervention (PCI) device technologies are often rapidly adopted into clinical practice, yet few studies have examined the overall impact of these new ...technologies on patient outcomes in community practice. Methods In hopes of determining temporal trends in PCI outcomes, we used data from the Centers for Medicare & Medicaid Service’s Chronic Condition Warehouse (n = 3,250,836) by comparing patient characteristics and rates of 3-year major adverse cardiac events (MACE) across the balloon angioplasty (POBA) era (01/1991-09/1995), the bare metal stent (BMS) era (02/1998-04/2003), and the drug-eluting stent (DES) era (05/2004-10/2006). The adjusted association between era and outcomes was determined with Cox proportional hazards modeling (POBA era as reference). Results Compared with the POBA era, patients undergoing PCI were significantly older and had more medical comorbidities, and the risk for 3-year MACE was significantly lower during the BMS and DES eras (BMS vs. POBA adjusted HR 95% CI: 0.930 0.926–0.935; DES vs. BMS: 0.831 0.827–0.835). Compared with males, the adjusted risk for 3-year MACE among females was lower during the POBA era, but slightly higher during the BMS and DES eras. Across all three eras, patients ≥75 years of age had higher adjusted risk for MACE compared with younger patients, and the risk for revascularization was lower for both females and older patients. Conclusions Despite its application in older and sicker Medicare beneficiaries, there has been a significant decrease in post-PCI MACE over time. The risk for death or myocardial infarction is higher among females and older patients compared with males and younger patients; therefore, future studies should focus on improving clinical outcomes in these high-risk subgroups.
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