BACKGROUND:Impella was approved for mechanical circulatory support (MCS) in 2008, but large-scale, real-world data on its use are lacking. Our objective was to describe trends and variations in ...Impella use, clinical outcomes, and costs across US hospitals in patients undergoing percutaneous coronary intervention (PCI) treated with MCS (Impella or intra-aortic balloon pump).
METHODS:From the Premier Healthcare Database, we analyzed 48 306 patients undergoing PCI with MCS at 432 hospitals between January 2004 and December 2016. Association analyses were performed at 3 levelstime period, hospital, and patient. Hierarchical models with propensity adjustment were used for association analyses. We examined trends and variations in the proportion of Impella use, and associated clinical outcomes (in-hospital mortality, bleeding requiring transfusion, acute kidney injury, stroke, length of stay, and hospital costs).
RESULTS:Among patients undergoing PCI treated with MCS, 4782 (9.9%) received Impella; its use increased over time, reaching 31.9% of MCS in 2016. There was wide variation in Impella use across hospitals (>5-fold variation). Specifically, among patients receiving Impella, there was a wide variation in outcomes of bleeding (>2.5-fold variation), and death, acute kidney injury, and stroke (all ≈1.5-fold variation). Adverse outcomes and costs were higher in the Impella era (years 2008–2016) versus the pre-Impella era (years 2004–2007). Hospitals with higher Impella use had higher rates of adverse outcomes and costs. After adjustment for the propensity score, and accounting for clustering of patients by hospitals, Impella use was associated with deathodds ratio, 1.24 (95% CI, 1.13–1.36); bleedingodds ratio, 1.10 (95% CI, 1.00–1.21); and strokeodds ratio, 1.34 (95% CI, 1.18–1.53), although a similar, nonsignificant result was observed for acute kidney injuryodds ratio, 1.08 (95% CI, 1.00–1.17).
CONCLUSIONS:Impella use is rapidly increasing among patients undergoing PCI treated with MCS, with marked variability in its use and associated outcomes. Although unmeasured confounding cannot be ruled out, when analyzed by time periods, or at the hospital level or the patient level, Impella use was associated with higher rates of adverse events and costs. More data are needed to define the appropriate role of MCS in patients undergoing PCI.
Trimethlyamine-N-oxide (TMAO) was recently identified as a promoter of atherosclerosis. Patients with CKD exhibit accelerated development of atherosclerosis; however, no studies have explored the ...relationship between TMAO and atherosclerosis formation in this group. This study measured serum concentrations and urinary excretion of TMAO in a CKD cohort (n=104), identified the effect of renal transplant on serum TMAO concentration in a subset of these patients (n=6), and explored the cross-sectional relationship between serum TMAO and coronary atherosclerosis burden in a separate CKD cohort (n=220) undergoing coronary angiography. Additional exploratory analyses examined the relationship between baseline serum TMAO and long-term survival after coronary angiography. Serum TMAO concentrations demonstrated a strong inverse association with eGFR (r(2)=0.31, P<0.001). TMAO concentrations were markedly higher in patients receiving dialysis (median interquartile range, 94.4 μM 54.8-133.0 μM for dialysis-dependent patients versus 3.3 μM 3.1-6.0 μM for healthy controls; P<0.001); whereas renal transplantation resulted in substantial reductions in TMAO concentrations (median min-max 71.2 μM 29.2-189.7 μM pretransplant versus 11.4 μM 8.9-20.2 μM post-transplant; P=0.03). TMAO concentration was an independent predictor for coronary atherosclerosis burden (P=0.02) and predicted long-term mortality independent of traditional cardiac risk factors (hazard ratio, 1.26 per 10 μM increment in TMAO concentration; 95% confidence interval, 1.13 to 1.40; P<0.001). In conclusion, serum TMAO concentrations substantially increase with decrements in kidney function, and this effect is reversed by renal transplantation. Increased TMAO concentrations correlate with coronary atherosclerosis burden and may associate with long-term mortality in patients with CKD undergoing coronary angiography.
CONTEXT Bleeding complications with percutaneous coronary intervention (PCI) are associated with adverse patient outcomes. The association between the use of bleeding avoidance strategies and ...post-PCI bleeding as a function of a patient's preprocedural risk of bleeding is unknown. OBJECTIVE To describe the use of 2 bleeding avoidance strategies, vascular closure devices and bivalirudin, and associated post-PCI bleeding rates in a nationally representative PCI population. DESIGN, SETTING, AND PATIENTS Analysis of data from 1 522 935 patients undergoing PCI procedures performed at 955 US hospitals participating in the National Cardiovascular Data Registry (NCDR) CathPCI Registry from January 1, 2004, through September 30, 2008. MAIN OUTCOME MEASURE Periprocedural bleeding. RESULTS Bleeding occurred in 30 654 patients (2%). Manual compression, vascular closure devices, bivalirudin, or vascular closure devices plus bivalirudin were used in 35%, 24%, 23%, and 18% of patients, respectively. Bleeding events were reported in 2.8% of patients who received manual compression, compared with 2.1%, 1.6%, and 0.9% of patients receiving vascular closure devices, bivalirudin, and both strategies, respectively (P < .001). Bleeding rates differed by preprocedural risk assessed with the NCDR bleeding risk model (low risk, 0.72%; intermediate risk, 1.73%; high risk, 4.69%). In high-risk patients, use of both strategies was associated with lower bleeding rates (manual compression, 6.1%; vascular closure devices, 4.6%; bivalirudin, 3.8%; vascular closure devices plus bivalirudin, 2.3%; P < .001). This association persisted following adjustment using a propensity-matched and site-controlled model. Use of both strategies was used least often in high-risk patients (14.4% vs 21.0% in low-risk patients, P < .001). CONCLUSIONS In a large national PCI registry, vascular closure devices and bivalirudin were associated with significantly lower bleeding rates, particularly among patients at greatest risk for bleeding. However, these strategies were less often used among higher-risk patients.
Contrast-induced acute kidney injury (AKI) is a common and severe complication of percutaneous coronary intervention (PCI). Despite its substantial burden, contemporary data on the incremental costs ...of AKI are lacking. We designed this large, nationally representative study to examine: (1) the independent, incremental costs associated with AKI after PCI and (2) to identify the departmental components of cost contributing to the incremental costs associated with AKI. In this observational cross-sectional study from the Premier database, we analyzed 1,443,297 PCI patients at 518 US hospitals from 1/2006 to 12/2015. Incremental cost of AKI from a hospital perspective obtained by a microcosting approach, was estimated using mixed-effects, multivariable linear regression with hospitals as random effects. Costs were inflation-corrected to 2016 US$. AKI occurred in 82,683 (5.73%) of the PCI patients. Those with AKI had higher hospitalization cost than those without ($38,869, SD 42,583 vs $17,167 SD 13,994, p <0.001). After adjustment, the incremental cost associated with an AKI was $9,448 (95% confidence interval $9,338 to $9,558, p <0.001). AKI was also independently associated with an incremental length of stay of 3.6 days (p <0.001). Room and board costs were the largest driver of AKI costs ($4,841). Extrapolated to the United States, our findings imply an annual AKI cost burden of 411.3 million US$. In conclusion, in this national study of PCI patients, AKI was common and independently associated with ∼$10,000 incremental costs, implying a substantial burden of AKI costs in US hospitals. Successful efforts to prevent AKI in patients who underwent PCI could result in meaningful cost savings.
IMPORTANCE Bleeding is the most common complication after percutaneous coronary intervention (PCI) and is associated with increased morbidity and health care costs. The incidence of bleeding-related ...mortality after PCI has not been described in a nationally representative population. Furthermore, the relationships among bleeding risk, bleeding site, and mortality are unclear. OBJECTIVES To describe the association between bleeding events and in-hospital mortality after PCI and to estimate the adjusted population attributable risk (estimated as the proportion of mortality risk associated with bleeding events), risk difference, and number needed to harm (NNH) for bleeding-related in-hospital mortality after PCI. DESIGN, SETTING, AND PATIENTS Data from 3 386 688 procedures in the CathPCI Registry performed in the United States between 2004 and 2011 were analyzed. The population attributable risk was calculated after adjustment for baseline demographic, clinical, and procedural variables. To calculate the NNH for bleeding-related mortality, a propensity-matched analysis was performed. MAIN OUTCOME MEASURES In-hospital mortality. RESULTS There were 57 246 bleeding events (1.7%) and 22 165 in-hospital deaths (0.65%) in 3 386 688 PCI procedures. The adjusted population attributable risk for mortality related to major bleeding was 12.1% (95% CI, 11.4%-12.7%) in the entire CathPCI cohort. The propensity-matched population consisted of 56 078 procedures with a major bleeding event and 224 312 controls. In this matched cohort, major bleeding was associated with increased in-hospital mortality (5.26% vs 1.87%; risk difference, 3.39% 95% CI, 3.20%-3.59%; NNH = 29 95% CI, 28-31; P < .001). The association between major bleeding and in-hospital mortality was observed in all strata of preprocedural bleeding risk (low: 1.62% vs 0.17%; risk difference, 1.45% 95% CI, 1.13%-1.77%, NNH = 69 95% CI, 57-88, P < .001; intermediate: 3.27% vs 0.71%; risk difference, 2.56% 95% CI, 2.33%-2.79%, NNH = 39 95% CI, 36-43, P < .001; and high: 8.16% vs 3.45%; risk difference, 4.71% 95% CI, 4.35%-5.07%, NNH = 21 95% CI, 20-23, P < .001). Although both access-site and non–access-site bleeding were associated with increased in-hospital mortality (2.73% vs 1.87%; risk difference, 0.86% 95% CI, 0.66%-1.05%, NNH = 117 95% CI, 95-151, P < .001; and 8.25% vs 1.87%; risk difference, 6.39% 95% CI, 6.04%-6.73%, NNH = 16 95% CI, 15-17, P < .001, respectively), the NNH was lower for nonaccess bleeding. CONCLUSIONS AND RELEVANCE In a large registry of patients undergoing PCI, postprocedural bleeding events were associated with increased risk of in-hospital mortality, with an estimated 12.1% of deaths related to bleeding complications.
The aim of this study was to examine the independent impact of various care pathways, including those involving transradial intervention (TRI) and same-day discharge (SDD) after elective percutaneous ...coronary intervention (PCI), on hospital costs.
PCI is associated with costs of $10 billion annually. Alternative payment models for PCI are being implemented, but few data exist on strategies to reduce costs. Various PCI care pathways, including TRI and SDD, exist, but their association with costs and outcomes is unknown.
In total, 279,987 PCI patients eligible for SDD in the National Cardiovascular Data Registry CathPCI Registry linked to Medicare claims files were analyzed. Hospital costs in 2014 U.S. dollars were estimated using cost-to-charge ratios. Propensity scores for TRI and SDD, with propensity adjustment via inverse probability weighting, was performed.
Of the 279,987 PCI procedures, TRI was used in 9.0% (13.5% of which were SDD), and SDD was used in 5.3% of cases (23.1% of which were TRI). TRI (vs. transfemoral intervention) was associated with lower adjusted costs of $916 (95% confidence interval CI: $778 to $1,035), as was SDD ($3,502; 95% CI: $3,486 to $3,902). The adjusted cost associated with TRI and SDD was $13,389 (95% CI: $13,161 to $13,607), while the cost associated with transfemoral intervention and non-same-day discharge was $17,076 (95% CI: $16,999 to $17,147), a difference of $3,689 (95% CI: $3,486 to $3,902; p < 0.0001). Shifting current practice from transfemoral intervention non-same-day discharge to TRI SDD by 30% could potentially save a hospital performing 1,000 PCIs each year $1 million and the country $300 million annually.
Among Medicare beneficiaries, TRI with SDD was independently associated with fewer complications and lower in-hospital costs. These findings have important implications for changing the current PCI care pathways to improve outcomes and reduce costs.
Acute coronary syndrome (ACS) admissions are common and costly. The association between comprehensive ACS care pathways, outcomes, and costs are lacking. From 434,172 low-risk, uncomplicated ACS ...patients eligible for early discharge (STEMI 35%, UA/NSTEMI 65%) from the Premier database, we identified ACS care pathways, by stratifying low-risk, uncomplicated STEMI and UA/NSTEMI patients by access site for PCI (trans-radial intervention TRI vs transfemoral intervention TFI) and by length of stay (LOS). Associations with costs and outcomes (death, bleeding, acute kidney injury, and myocardial infarction at 1-year) were tested using hierarchical, mixed-effects regression, and projections of cost savings with change in care pathways were obtained using modeling. In low-risk uncomplicated STEMI patients, compared with TFI and LOS ≥3 days, a strategy of TRI with LOS <3 days and TFI with LOS <3 days were associated with cost savings of $6,206 and $4,802, respectively. Corresponding cost savings for UA/NSTEMI patients were $7,475 and $6,169, respectively. These care-pathways did not show an excess risk of adverse outcomes. We estimated that >$300 million could be saved if prevalence of the TRI with LOS <3 days and TFI with LOS <3 days strategies are modestly increased to 20% and 70%, respectively. In conclusion, we demonstrate the potential opportunity of cost savings by repositioning ACS care pathways in low-risk and uncomplicated ACS patients, toward transradial access and a shorter LOS without an increased risk of adverse outcomes.
Abstract Objectives The aim of this study was to examine the independent impact of various care pathways, including those involving transradial intervention (TRI) and same-day discharge (SDD) after ...elective percutaneous coronary intervention (PCI), on hospital costs. Background PCI is associated with costs of $10 billion annually. Alternative payment models for PCI are being implemented, but few data exist on strategies to reduce costs. Various PCI care pathways, including TRI and SDD, exist, but their association with costs and outcomes is unknown. Methods In total, 279,987 PCI patients eligible for SDD in the National Cardiovascular Data Registry CathPCI Registry linked to Medicare claims files were analyzed. Hospital costs in 2014 U.S. dollars were estimated using cost-to-charge ratios. Propensity scores for TRI and SDD, with propensity adjustment via inverse probability weighting, was performed. Results Of the 279,987 PCI procedures, TRI was used in 9.0% (13.5% of which were SDD), and SDD was used in 5.3% of cases (23.1% of which were TRI). TRI (vs. transfemoral intervention) was associated with lower adjusted costs of $916 (95% confidence interval CI: $778 to $1,035), as was SDD ($3,502; 95% CI: $3,486 to $3,902). The adjusted cost associated with TRI and SDD was $13,389 (95% CI: $13,161 to $13,607), while the cost associated with transfemoral intervention and non-same-day discharge was $17,076 (95% CI: $16,999 to $17,147), a difference of $3,689 (95% CI: $3,486 to $3,902; p < 0.0001). Shifting current practice from transfemoral intervention non-same-day discharge to TRI SDD by 30% could potentially save a hospital performing 1,000 PCIs each year $1 million and the country $300 million annually. Conclusions Among Medicare beneficiaries, TRI with SDD was independently associated with fewer complications and lower in-hospital costs. These findings have important implications for changing the current PCI care pathways to improve outcomes and reduce costs.
BACKGROUND:In patients with severe aortic stenosis (AS) at intermediate surgical risk, treatment with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) results ...in similar rates of death or stroke at 2 years. Whether TAVR is cost-effective compared with SAVR for intermediate-risk patients remains uncertain.
METHODS:Between 2011 and 2014, 3110 intermediate-risk AS patients were treated with TAVR or SAVR in the PARTNER 2 trial (Placement of Aortic Transcatheter Valves 2). A total of 2032 patients were randomized to receive TAVR using the SAPIEN XT valve (XT-TAVR) or SAVR in the PARTNER 2A trial, whereas the PARTNER S3i registry included an additional 1078 patients treated with TAVR using the SAPIEN 3 valve (S3-TAVR), which offers a lower delivery profile and sealing skirt designed to reduce paravalvular regurgitation compared with XT-TAVR. Procedural costs were estimated using measured resource utilization. Other in-trial costs were assessed by linkage of trial data with Medicare claims (n=2333) or by linear regression models for unlinked patients (n=682). Health utilities were estimated using the EQ-5D at baseline and 1, 12, and 24 months. Using a Markov model informed by in-trial costs, utilities, and survival data, lifetime cost-effectiveness from the perspective of the US healthcare system was estimated in terms of cost per quality-adjusted life-year gained.
RESULTS:Although procedural costs were ≈$20 000 higher with TAVR than SAVR, total cost differences for the index hospitalization were only $2888 higher with XT-TAVR (P=0.014) and were $4155 lower with S3-TAVR (P<0.001) owing to reductions in length of stay with TAVR. Follow-up costs were significantly lower with XT-TAVR (Δ=−$9304; P<0.001) and S3-TAVR (Δ=−$11 377; P<0.001) than with SAVR. Over a lifetime horizon, TAVR was projected to lower total costs by $8000 to $10 000 and to increase quality-adjusted survival by 0.15 to 0.27 years. XT-TAVR and S3-TAVR were found to be economically dominant compared with SAVR in 84% and 97% of bootstrap replicates, respectively.
CONCLUSIONS:Among intermediate-risk AS patients, TAVR is projected to be economically dominant from the perspective of the US healthcare system by providing both greater quality-adjusted life expectancy and lower long-term costs than SAVR. If long-term data demonstrate comparable late mortality with TAVR and SAVR, these findings suggest that TAVR might be the preferred treatment strategy for intermediate-risk AS patients based on both clinical and economic considerations.
CLINICAL TRIAL REGISTRATION:URLhttps://www.clinicaltrials.gov. Unique identifierNCT01314313.
BACKGROUND—Bleeding in patients undergoing percutaneous coronary intervention (PCI) is associated with increased morbidity, mortality, length of hospitalization, and cost. We identified baseline ...clinical characteristics associated with bleeding complications after PCI and developed a simplified, clinically useful algorithm to predict patient risk.
METHODS AND RESULTS—Data were analyzed from 302 152 PCI procedures performed at 440 US centers participating in the National Cardiovascular Data Registry. As defined by the National Cardiovascular Data Registry, bleeding required transfusion, prolonged hospital stay, and/or a drop in hemoglobin >3.0 g/dL from any location, including percutaneous entry site, retroperitoneal, gastrointestinal, genitourinary, and other/unknown location. Bleeding complications occurred in 2.4% of patients. From the best-fitting model consisting of 15 clinical elements associated with post-PCI bleeding in a random 80% training cohort, we developed a parsimonious risk algorithm. Predictors of bleeding included age, gender, previous heart failure, glomerular filtration rate, peripheral vascular disease, no previous PCI, New York Heart Association/Canadian Cardiovascular Society Functional Classification class IV heart failure, ST-elevation myocardial infarction, non–ST-elevation myocardial infarction, and cardiogenic shock. The parsimonious model was validated in the remaining 20% of the population (c-statistic, 0.72) and in clinically relevant subgroups of patients. This simplified model was used to derive a clinical risk algorithm, with larger numbers corresponding with greater risk. In 3 categories, bleeding rates were greater in patients with higher estimates (≤7, 0.7%; 8 to 17, 1.8%; ≥18, 5.1%).
CONCLUSIONS—This report identifies baseline clinical factors associated with bleeding and proposes a clinically useful algorithm to estimate bleeding risk. This model is potentially actionable in altering therapeutic decision making and improving outcomes in patients undergoing PCI.
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