The Evolving Landscape of Impella Use in the United States Among Patients Undergoing Percutaneous Coronary Intervention With Mechanical Circulatory Support.

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 levels: time 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 death: odds ratio, 1.24 (95% CI, 1.13-1.36); bleeding: odds ratio, 1.10 (95% CI, 1.00-1.21); and stroke: odds ratio, 1.34 (95% CI, 1.18-1.53), although a similar, nonsignificant result was observed for acute kidney injury: odds 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.

Resource and Infrastructure-Appropriate Management of ST-Segment Elevation Myocardial Infarction in Low- and Middle-Income Countries.

The 143 low- and middle-income countries (LMICs) of the world constitute 80% of the world's population or roughly 5.86 billion people with much variation in geography, culture, literacy, financial resources, access to health care, insurance penetration, and healthcare regulation. Unfortunately, their burden of cardiovascular disease in general and acute ST-segment-elevation myocardial infarction (STEMI) in particular is increasing at an unprecedented rate. Compounding the problem, outcomes remain suboptimal because of a lack of awareness and a severe paucity of resources. Guideline-based treatment has dramatically improved the outcomes of STEMI in high-income countries. However, no such focused recommendations exist for LMICs, and the unique challenges in LMICs make directly implementing Western guidelines unfeasible. Thus, structured solutions tailored to their individual, local needs, and resources are a vital need. With this in mind, a multicountry collaboration of investigators interested in LMIC STEMI care have tried to create a consensus document that extracts transferable elements from Western guidelines and couples them with local realities gathered from expert experience. It outlines general operating principles for LMICs focused best practices and is intended to create the broad outlines of implementable, resource-appropriate paradigms for management of STEMI in LMICs. Although this document is focused primarily on governments and organizations involved with improvement in STEMI care in LMICs, it also provides some specific targeted information for the frontline clinicians to allow standardized care pathways and improved outcomes.

Differences in risk factors and resource utilization for women undergoing percutaneous coronary intervention and lower extremity peripheral vascular intervention.

OBJECTIVE: To investigate the differences in risk factors and in-hospital outcomes for women undergoing percutaneous coronary intervention (PCI) and peripheral vascular intervention (PVI). BACKGROUND: The clinical impact of coronary artery disease (CAD) and peripheral artery disease (PAD) is well characterized and is associated with high morbidity and mortality. There is lack of data comparing risk factors and in-hospital outcomes for PCI and PVI, particularly in women. METHODS: Only female hospitalizations (age ≥ 18 years) who underwent PCI or PVI from 2005 to 2014 were identified using appropriate International Classification of Diseases-Ninth Revision, Clinical Modification codes from the National Inpatient Sample database. Charlson's Comorbidity Index (CCI) was selected as the primary endpoint of the study. Coprimary endpoint was the cost of hospitalizations associated with PCI or PVI. RESULTS: Of the 2,461,328 female hospitalizations that were included, 85.6% (N = 2,105,236) underwent PCI and 14.4% (N = 356,092) received PVI. Compared to PCI, PVI hospitalizations were 3.2 years older (p < .001) and consisted of significantly more hospitalizations above 80 years of age (26.5% vs. 18.6%; p < .001). Hospitalizations with CCI ≥3 were significantly higher in the PVI cohort (29.1% vs. 24%; p < .001). CCI in women increased during the study period for both groups. PVI hospitalizations had a significantly longer length of stay (3 days vs. 2 days; p < .001) and cost of hospitalization ($23,610 vs. $20,571; p < .001), compared to PCI. Finally, the mean cost of hospitalizations increased during the study period for PCI and PVI. CONCLUSION: Women hospitalized for PVI had a greater risk-profile and resource utilization as demonstrated by the longer length of stay and higher cost compared to PCI.

Contemporary trend of acute kidney injury incidence and incremental costs among US patients undergoing percutaneous coronary procedures.

OBJECTIVES: To assess national trends of acute kidney injury (AKI) incidence, incremental costs, risk factors, and readmissions among patients undergoing coronary angiography (CAG) and/or percutaneous coronary intervention (PCI) during 2012-2017. BACKGROUND: AKI remains a serious complication for patients undergoing CAG/PCI. Evidence is lacking in contemporary AKI trends and its impact on hospital resource utilization. METHODS: Patients who underwent CAG/PCI procedures in 749 hospitals were identified from Premier Healthcare Database. AKI was defined by ICD-9/10 diagnosis codes (584.9/N17.9, 583.89/N14.1, 583.9/N05.9, E947.8/T50.8X5) during 7 days post index procedure. Multivariable regression models were used to adjust for confounders. RESULTS: Among 2,763,681 patients, AKI incidence increased from 6.0 to 8.4% or 14% per year in overall patients; from 18.0 to 28.4% in those with chronic kidney disease (CKD) and from 2.4 to 4.2% in those without CKD (all p < .001). Significant risk factors for AKI included older age, being uninsured, inpatient procedures, CKD, anemia, and diabetes (all p < .001). AKI was associated with higher 30-day in-hospital mortality (ORadjusted = 2.55; 95% CI: 2.40, 2.70) and readmission risk (ORadjusted = 1.52; 95% CI: 1.50, 1.55). The AKI-related incremental cost during index visit and 30-day readmissions were estimated to be $8,416 and $580 per inpatient procedure and $927 and $6,145 per outpatient procedure. Overall excess healthcare burden associated with AKI was $1.67 billion. CONCLUSIONS: AKI incidence increased significantly in this large, multifacility sample of patients undergoing CAG/PCI procedures and was associated with substantial increase in hospital costs, readmissions, and mortality. Efforts to reduce AKI risk in US healthcare system are warranted.

Temporal trends in the utilization and outcomes of percutaneous coronary interventions in patients with liver cirrhosis.

OBJECTIVES: We sought to assess the national trends in the utilization and outcomes of percutaneous coronary interventions (PCI) in patients with cirrhosis. BACKGROUND: Contemporary data on PCI in patients with liver cirrhosis are limited. METHODS: The National-Inpatient-Sample was used to identify patients who underwent PCI between 2003 and 2016. We examined the annual PCI rate, and compared the in-hospital morbidity, mortality, resource utilization, and cost following PCI in patients with and without cirrhosis. RESULTS: A total of 8,860,178 PCI hospitalizations were identified, of those, 20,339 (0.2%) were performed in patients with cirrhosis. Annual PCI rates decreased overtime in patients without liver cirrhosis but increased in those with cirrhosis (Ptrend < .001). Patients with cirrhosis had a characteristic clinical, demographic, and socioeconomic profile compared with those without cirrhosis. The use of bare-metal stents decreased from 69.1 to 11.4% in the noncirrhosis group, and from 81.9 to 21.3% in the cirrhosis group. Compared with propensity-matched patients without cirrhosis, PCI in cirrhotic patients was associated with higher in-hospital mortality across all indications (STEMI 19.1 vs. 11.5%, p = .002; NSTEMI 8.7 vs. 5.6%, p = .002; and UA/SIHD 7.7 vs. 4.3%, p < .001). Cirrhotic patients also had significantly higher rates of acute kidney injury, but similar rates of vascular complications and stroke. Additionally, cirrhotic patients had longer hospitalizations, were less likely to be discharged home, and accrued higher cost across all PCI indications. CONCLUSIONS: Patients with cirrhosis who are deemed "suitable PCI candidates" in current practice remain at high-risk for worse short-term morbidity and mortality, and higher cost of care.

Cost-Effectiveness of Multigene Pharmacogenetic Testing in Patients With Acute Coronary Syndrome After Percutaneous Coronary Intervention.

OBJECTIVE: To evaluate the cost-effectiveness of multigene testing (CYP2C19, SLCO1B1, CYP2C9, VKORC1) compared with single-gene testing (CYP2C19) and standard of care (no genotyping) in acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI) from Medicare's perspective. METHODS: A hybrid decision tree/Markov model was developed to simulate patients post-PCI for ACS requiring antiplatelet therapy (CYP2C19 to guide antiplatelet selection), statin therapy (SLCO1B1 to guide statin selection), and anticoagulant therapy in those that develop atrial fibrillation (CYP2C9/VKORC1 to guide warfarin dose) over 12 months, 24 months, and lifetime. The primary outcome was cost (2016 US dollar) per quality-adjusted life years (QALYs) gained. Costs and QALYs were discounted at 3% per year. Probabilistic sensitivity analysis (PSA) varied input parameters (event probabilities, prescription costs, event costs, health-state utilities) to estimate changes in the cost per QALY gained. RESULTS: Base-case-discounted results indicated that the cost per QALY gained was $59 876, $33 512, and $3780 at 12 months, 24 months, and lifetime, respectively, for multigene testing compared with standard of care. Single-gene testing was dominated by multigene testing at all time horizons. PSA-discounted results indicated that, at the $50 000/QALY gained willingness-to-pay threshold, multigene testing had the highest probability of cost-effectiveness in the majority of simulations at 24 months (61%) and over the lifetime (81%). CONCLUSIONS: On the basis of projected simulations, multigene testing for Medicare patients post-PCI for ACS has a higher probability of being cost-effective over 24 months and the lifetime compared with single-gene testing and standard of care and could help optimize medication prescribing to improve patient outcomes.

Economic Analysis of Surgical and Interventional Treatments for Patients with Complex Coronary Artery Disease: Insights from a One-Year Single-Center Study.

BACKGROUND Surgical treatment methods for patients with complex coronary artery disease (CAD) who have undergone vascular reconstruction mainly include coronary artery bypass graft (CABG) and percutaneous coronary intervention (PCI). The purpose of the study aimed to compare a 1-year follow-up for the patient clinical outcomes and costs between PCI and CABG treatment. MATERIAL AND METHODS There were 840 patients enrolled in this study from July 2015 to September 2016. Among the study participants, 420 patients underwent PCI treatment and 420 patients underwent off-pump CABG. Patients costs were assessed from the perspective of the China healthcare and medical insurance system. EuroQOL 5-dimension 3 levels (EQ-5D-3L) questionnaire was used to evaluate the general health status, and the Seattle Angina Questionnaire (SAQ) was used to assess the disease-specific health status. RESULTS After a 1-year follow-up, the all-cause mortality (P=0.0337), the incidence of major adverse cardiac and cerebrovascular events (P<0.001), and additional revascularization (P<0.001) in PCI group were significantly higher than those in CABG group. Both groups have significant sustained benefits in the SAQ subscale. The CABG group had a higher score on the frequency of angina than the PCI group. In addition, the quality-adjusted life year value of PCI and CABG resulted was 0.8. The average total cost for PCI was $14 643 versus CABG cost of $13 842 (P=0.0492). CONCLUSIONS In the short-term, among the CAD patients with stable triple-vessel or left-main, costs and clinical outcomes are substantially higher for CABG than PCI. Long-term, economic, and health benefits analysis, is warranted.

Cost-effectiveness and Outcomes with Early or Same-Day Discharge After Elective Percutaneous Coronary Intervention.

PURPOSE OF REVIEW: Shorter hospital stay after percutaneous coronary intervention (PCI) can provide economic advantage. Same-day discharge (SDD) after transradial PCI is thought to reduce the cost of care while maintaining the quality and safety. This review summarizes the current knowledge of the benefits and safety of this concept. RECENT FINDINGS: Increase in rate of transradial PCI over the last two decades has resulted in recent growth in rate of acceptance of SDD after a successful procedure. SDD is shown to result in savings of $3500 to $5200 per procedure with comparable adverse event rate of traditional discharge processes. SDD after PCI is shown to be safe and results in cost advantage maintaining the safety profile. The acceptance rate of SDD is still not optimum, and further market penetration of SDD practice would be achieved only if the institutional and operator preference barriers are addressed.

Prevalence, Outcomes and Cost Implications of Patients Undergoing Same Day Discharge After Elective Percutaneous Coronary Intervention in Australia.

BACKGROUND: Despite international growth in the use of same day percutaneous coronary intervention (PCI), its widespread use remains limited. This study sought to determine the prevalence, clinical outcomes and cost implications of same day discharge (SDD) amongst Australian patients undergoing elective PCI. METHODS: This is a retrospective, observational cohort study of patients who underwent elective PCI in Victoria between January 2014 and December 2017. Data from this study was obtained from the Victorian Cardiac Outcomes Registry (VCOR). The primary outcome measured was the incidence of 30-day major adverse cardiac events (MACE) and secondary outcomes included in hospital complications and 30-day readmissions, between SDD patients and those observed as inpatients overnight (ON). Propensity score matching for key clinical factors were used to compare both groups. RESULTS: We studied 18,101 patients, with a mean age of 68±11years and 13,935 (77%) were male. The rate of SDD was 586 (3.2%) and 17,515 (96.8%) patients stayed in hospital overnight. Radial access was performed in 393 (67.1%) and 7,967 (45.5%) among SDD and ON patients respectively (p<0.001). At 30 days, unplanned cardiac re-hospitalisation occurred in 9.6% (n=56) amongst SDD and 11.6%, (n=2,033) amongst ON patients (p=0.173). Propensity matching highlighted SDD to be non-inferior to overnight, with no significant difference in 30-day MACE (0.5%, 95% CI: 0.34, 1.35) but SDD was associated with reduced average length of stay by 2.06 days (95% CI: 1.94, 2.19). We observed substantial hospital variation for SDD from 0% to 16.6% of elective PCI procedures. CONCLUSIONS: Same day discharge after elective PCI is performed infrequently in Victoria. Despite this, SDD appears to be safe and feasible. Given significant benefits in cost and bed utilisation, a more consistent use of SDD could markedly improve the value of PCI care in Australia.

Clinical Outcomes and Cost-Effectiveness of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention in Patients With Stable Coronary Artery Disease: Three-Year Follow-Up of the FAME 2 Trial (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation).

BACKGROUND: Previous studies found that percutaneous coronary intervention (PCI) does not improve outcome compared with medical therapy (MT) in patients with stable coronary artery disease, but PCI was guided by angiography alone. FAME 2 trial (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation) compared PCI guided by fractional flow reserve with best MT in patients with stable coronary artery disease to assess clinical outcomes and cost-effectiveness. METHODS: A total of 888 patients with stable single-vessel or multivessel coronary artery disease with reduced fractional flow reserve were randomly assigned to PCI plus MT (n=447) or MT alone (n=441). Major adverse cardiac events included death, myocardial infarction, and urgent revascularization. Costs were calculated on the basis of resource use and Medicare reimbursement rates. Changes in quality-adjusted life-years were assessed with utilities determined by the European Quality of Life-5 Dimensions health survey at baseline and over follow-up. RESULTS: Major adverse cardiac events at 3 years were significantly lower in the PCI group compared with the MT group (10.1% versus 22.0%; P<0.001), primarily as a result of a lower rate of urgent revascularization (4.3% versus 17.2%; P<0.001). Death and myocardial infarction were numerically lower in the PCI group (8.3% versus 10.4%; P=0.28). Angina was significantly less severe in the PCI group at all follow-up points to 3 years. Mean initial costs were higher in the PCI group ($9944 versus $4440; P<0.001) but by 3 years were similar between the 2 groups ($16 792 versus $16 737; P=0.94). The incremental cost-effectiveness ratio for PCI compared with MT was $17 300 per quality-adjusted life-year at 2 years and $1600 per quality-adjusted life-year at 3 years. The above findings were robust in sensitivity analyses. CONCLUSIONS: PCI of lesions with reduced fractional flow reserve improves long-term outcome and is economically attractive compared with MT alone in patients with stable coronary artery disease. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01132495.

Same-day discharge among patients undergoing elective PCI: Insights from the VA CART Program.

BACKGROUND: Available data suggest that same-day discharge (SDD) after elective percutaneous coronary intervention (PCI) is safe in select patients. Yet, little is known about contemporary adoption rates, safety, and costs in a universal health care system like the Veterans Affairs Health System. METHODS: Using data from the Veterans Affairs Clinical Assessment Reporting and Tracking Program linked with Health Economics Resource Center data, patients undergoing elective PCI for stable angina between October 1, 2007 and Sepetember 30, 2016, were stratified by SDD versus overnight stay. We examined trends of SDD, and using 2:1 propensity matching, we assessed 30-day rates of readmission, mortality, and total costs at 30 days. RESULTS: Of 21,261 PCIs from 67 sites, 728 were SDDs (3.9% of overall cohort). The rate of SDD increased from 1.6% in 2008 to 9.7% in 2016 (P < .001). SDD patients had lower rates of atrial fibrillation, peripheral arterial disease, and prior coronary artery bypass grafting and were treated at higher-volume centers. Thirty-day readmission and mortality did not differ significantly between the groups (readmission: 6.7% SDD vs 5.6% for overnight stay, P = .24; mortality: 0% vs. 0.07%, P = .99). The mean (SD) 30-day cost accrued by patients undergoing SDD was $23,656 ($15,480) versus $25,878 ($17,480) for an overnight stay. The accumulated median cost savings for SDD was $1503 (95% CI $738-$2,250). CONCLUSIONS: Veterans Affairs Health System has increasingly adopted SDD for elective PCI procedures, and this is associated with cost savings without an increase in readmission or mortality. Greater adoption has the potential to reduce costs without increasing adverse outcomes.

Cost-effectiveness analysis of pharmacogenomics-guided clopidogrel treatment in Spanish patients undergoing percutaneous coronary intervention.

Clopidogrel is an antiplatelet drug given to patients before and after having a percutaneous coronary intervention (PCI). Genomic variants in the CYP2C19 gene are associated with variable enzyme activities affecting drug metabolism and hence, patients with reduced or increased enzymatic function have increased risk of bleeding. We conducted a cost-effectiveness analysis to compare a pharmacogenomics versus a non-pharmacogenomics-guided clopidogrel treatment for coronary artery syndrome patients undergoing PCI in the Spanish healthcare setting. A total of 549 patients diagnosed with coronary artery disease followed by PCI were recruited. Dual antiplatelet therapy was administrated to all patients from 1 to 12 months after PCI. Patients were classified into two groups: the Retrospective group was treated with clopidogrel based on the clinical routine practice and the Prospective group were initially genotyped for the presence of CYP2C19 variant alleles before treatment with those carrying more than one CYP2C19 variant alleles given prasugrel treatment. We collected data on established clinical and health outcome measures, including, per treatment arm: the percentage of patients that suffered from (a) myocardial infraction, (b) major bleeding and minor bleeding, (c) stroke, (d) the number of hospitalization days, and (e) the number of days patients spent in Intensive Care Unit. Our primary outcome measure for the cost-effectiveness analysis was Quality Adjusted Life Years (QALYs). To estimate the treatment cost for each patient, individual data on its resource used were combined with unit price data, obtained from Spanish national sources. The analysis predicts a survival of 0.9446 QALYs in the pharmacogenomics arm and 0.9379 QALYs in the non-pharmacogenomics arm within a 1-year horizon. The cumulative costs per patient were €2971 and €3205 for the Prospective and Retrospective groups, respectively. The main cost driver of total cost in both arms was hospitalization costs. The incremental cost-effectiveness ratio (ICER) was negative indicating that the PGx was a dominant option. Our data show that pharmacogenomics-guided clopidogrel treatment strategy may represent a cost-effective choice compared with non-pharmacogenomics-guided strategy for patients undergoing PCI.

Comparative Effectiveness of Medical Therapy, Percutaneous Revascularization, and Surgical Coronary Revascularization in Cardiovascular Risk Subgroups of Patients With CKD: A Retrospective Cohort Study of Medicare Beneficiaries.

RATIONALE & OBJECTIVE: Prior studies suggesting that medical therapy is inferior to percutaneous (percutaneous coronary intervention [PCI]) or surgical (coronary artery bypass grafting [CABG]) coronary revascularization in chronic kidney disease (CKD) have not adequately considered medication optimization or baseline cardiovascular risk and have infrequently evaluated progression to kidney failure. We compared, separately, the risks for kidney failure and death after treatment with PCI, CABG, or optimized medical therapy for coronary disease among patients with CKD stratified by cardiovascular disease risk. STUDY DESIGN: Retrospective cohort study. SETTING & PARTICIPANTS: 34,385 individuals with CKD identified from a national 20% Medicare sample who underwent angiography or diagnostic stress testing without (low risk) or with (medium risk) prior cardiovascular disease or who presented with acute coronary syndrome (high risk). EXPOSURES: PCI, CABG, or optimized medical therapy (defined by the addition of cardiovascular medications in the absence of coronary revascularization). OUTCOMES: Death, kidney failure, composite outcome of death or kidney failure. ANALYTICAL APPROACH: Adjusted relative rates of death, kidney failure, and the composite of death or kidney failure estimated from Cox proportional hazards models. RESULTS: Among low-risk patients, 960 underwent PCI, 391 underwent CABG, and 6,426 received medical therapy alone; among medium-risk patients, 1,812 underwent PCI, 512 underwent CABG, and 9,984 received medical therapy alone; and among high-risk patients, 4,608 underwent PCI, 1,330 underwent CABG, and 8,362 received medical therapy alone. Among low- and medium-risk patients, neither CABG (HRs of 1.22 [95% CI, 0.96-1.53] and 1.08 [95% CI, 0.91-1.29] for low- and medium-risk patients, respectively) nor PCI (HRs of 1.14 [95% CI, 0.98-1.33] and 1.02 [95% CI, 0.93-1.12], respectively) were associated with reduced mortality compared with medical therapy, but in low-risk patients, CABG was associated with a higher rate of the composite, death or kidney failure (HR, 1.25; 95% CI, 1.02-1.53). In high-risk patients, CABG and PCI were associated with lower mortality (HRs of 0.57 [95% CI, 0.51-0.63] and 0.70 [95% CI, 0.66-0.74], respectively). Also, in high-risk patients, CABG was associated with a higher rate of kidney failure (HR, 1.40; 95% CI, 1.16-1.69). LIMITATIONS: Possible residual confounding; lack of data for coronary angiography or left ventricular ejection fraction; possible differences in decreased kidney function severity between therapy groups. CONCLUSIONS: Outcomes associated with cardiovascular therapies among patients with CKD differed by baseline cardiovascular risk. Coronary revascularization was not associated with improved survival in low-risk patients, but was associated with improved survival in high-risk patients despite a greater observed rate of kidney failure. These findings may inform clinical decision making in the care of patients with both CKD and cardiovascular disease.

Cost-effectiveness of coronary artery bypass graft and percutaneous coronary intervention compared to medical therapy in patients with coronary artery disease: a systematic review.

Coronary artery disease (CAD) has significant social and economic implications. It is necessary to create tools to identify the most cost-effectiveness treatments, which can assist clinicians in their therapeutic decisions so that the maximum possible benefit is reached with the lowest possible cost. Effectiveness must be measured by final treatment goals in which the most effective interventions are those with the lowest costs. This study is aimed to systematically review and compare the studies conducted on the cost-effectiveness of the three coronary artery disease treatment strategies (medical treatment, percutaneous coronary intervention, and coronary artery bypass graft). In this systematic review, the databases NHS Economic Evaluation Database, Embase, MEDLINE, Science Direct, and Scopus were searched for studies on the cost-effectiveness of coronary artery bypass graft (CABG) and percutaneous coronary intervention (PCI) compared to medical therapy (MT) in patients with coronary artery disease between 1 January 2004 to 30 September 2018. The quality appraisal of the included studies was examined using the Consolidated Health Economics Evaluation Reporting Standards (CHEERS) statement. Out of 186 unique retrievals, 8 studies were included. The results showed that the all studies clearly stated the time horizon of the study and included direct medical costs in their analysis. In addition, in most of the studies, quality-adjusted life years (QALY) were the main outcome used for measuring the effectiveness. The studies reported various ranges of the incremental cost-effectiveness ratio (ICER); accordingly, the highest ratio was observed in the USA ($212,800) for PCI v MT and the lowest ratio was observed in Brazil ($4403) for CABG v MT. Although the results of the studies were different in terms of a number of aspects, such as the viewpoint of the study, the study horizons, and the costs of expenditure items, they reached similar results. Based on the result of the present study, it seems that each three treatment strategies for CAD yielded improvements in QALY.

The influence of Elixhauser comorbidity index on percutaneous coronary intervention outcomes.

BACKGROUND: Clinical outcomes with respect to the evolution of comorbidity burden in national cohorts of patients undergoing PCI have not been reported. OBJECTIVES: We sought to explore the association between comorbidity burden and periprocedural outcomes in patients treated with PCI in the National Inpatient Sample. METHODS: 6,601,526 PCI procedures were identified between 2004 and 2014 and comorbidities were defined by the Elixhauser classification system (ECS) consisting of 30 comorbidity measures. Endpoints included in-hospital mortality, periprocedural complications, length of stay and cost. Patients were classified based on their ECS in five categories (ECS I < 0, ECS II = 0, ECS III = 1-5, ECS IV = 6-13, and ECS V ≥ 14). RESULTS: Patients with a score over 13 had a fivefold increase in the odds of mortality (OR: 5.13, 95% CI: 4.76-5.54), major bleeding (OR: 11.46, 95% CI: 10.66-12.33) and doubled the hospitalization costs ($31,452 vs $17.566). CONCLUSIONS: Our study of over six million PCI procedures demonstrates that patients with the greatest comorbid burden (as defined by an ECS of >13) have a fivefold increase risk of in-hospital mortality, a fourfold increase in in-hospital periprocedural complications and an 11-fold increase in major bleeding events once differences in baseline patient characteristics are adjusted for. In addition, ECS significantly impacts the length of stay and doubles the healthcare costs. Comorbid burden is an important predictor of poor outcomes after PCI and should be considered as part of the decision-making processes in patients undergoing PCI.

Incidence and outcomes of early percutaneous coronary intervention after isolated valve surgery.

BACKGROUND: Coronary ischemia requiring early percutaneous coronary intervention (PCI) is a rare but serious complication of isolated valve surgery. We sought of assess the incidence, predictors and outcomes of early PCI after isolated valve surgery using the national inpatient sample. METHODS: Patients who underwent isolated aortic valve replacement (AVR), isolated mitral valve repair (MVr) or replacement (MVR) between 2003 and 2014 were identified. Patients who had early postoperative PCI were compared with patients who did not require PCI. Primary end point was in-hospital mortality. Secondary endpoints were complications, length-of-stay and cost. RESULTS: Among the 135,611 included patients, 1,074 (0.8%) underwent PCI prior to discharge. Unadjusted in-hospital mortality was higher in patients requiring early PCI following AVR (11.2 vs. 3.1%), MVR (24.1 vs. 5.5%), and MVr (22.4 vs. 2.5%) (P < 0.001) compared with patients not requiring PCI. Postoperative PCI remained independently associated with higher mortality after adjusting for demographics, comorbidities and hospital characteristics (adjusted OR [aOR] = 3.74, 95%CI 2.70-5.17 for AVR, aOR = 6.10, 95%CI 4.53-8.23 for MVR, and aOR = 9.90, 95%CI 7.22-13.58 for MVr). Patients undergoing PCI had higher incidences of stroke, acute kidney injury, infectious complications, higher hospital charges, and longer hospitalizations. Age, robotic-assisted surgery, and chronic renal failure were independent predictors of needing early postoperative PCI. CONCLUSIONS: Early PCI after isolated aortic or mitral valve surgery is rare but is associated with substantial in-hospital morbidity, mortality, and cost. Further studies are needed to identify preventable causes, and optimal management strategies of this serious complication.

Frequency of 30-day readmission and its causes after percutaneous coronary intervention in acute myocardial infarction complicated by cardiogenic shock.

BACKGROUND: Survival after percutaneous coronary intervention (PCI) in acute myocardial infarction complicated by cardiogenic shock (AMI-CS) has increased over the years. Short-term readmission rates in this high-risk population remain unknown. METHODS: We queried the United States (U.S.) Nationwide Readmission Database (NRD) from January 2010 to November 2014 using the International Classification of Diseases-Ninth edition, Clinical Modification (ICD-9 CM) codes to identify all patients ≥18 years readmitted within 30 days after surviving an index hospitalization for PCI in AMI-CS. Incidence, etiologies, and predictors of 30-day readmission were analyzed. RESULTS: Among 46,435 patients who survived to discharge after PCI in AMI-CS, 9,020 (19.4%) were readmitted within 30 days. Median time to 30-day readmission was 11 days. Cardiac conditions were the most common causes of readmission (57.8%). Heart failure was the leading readmission diagnosis (24.8%). Private insurance including HMO and self-pay were predictive of lower 30-day readmission. Among other covariates, female sex, comorbidities such as heart failure, atrial fibrillation, in-hospital complications such as major bleeding, sepsis, respiratory complications, AKI requiring dialysis, utilization of mechanical circulatory support (IABP and ECMO) were independently predictive of 30-day readmission. Trend analysis showed decline in 30-day readmission rates from 21.9% in 2010 to 17.9% in 2014 (ptrend < 0.001). CONCLUSION: In this large real-world database, one in five patients receiving PCI in AMI-CS was readmitted within 30 days after discharge. Cardiac conditions were the most common causes of readmission. Insurance type had significant influence on 30-day readmission.

Cost-Effectiveness of Percutaneous Coronary Intervention Compared With Medical Therapy for Ischemic Heart Disease in Japan.

BACKGROUND: The cost-effectiveness of percutaneous coronary intervention (PCI) for ischemic heart disease is undetermined in Japan. The aim of this study was to analyze the cost-effectiveness of PCI compared with medical therapy for ST-elevation myocardial infarction (STEMI) and angina pectoris (AP) in Japan.Methods and Results:We used Markov models for STEMI and AP to assess the costs and benefits associated with PCI or medical therapy from a health system perspective. We estimated the incremental cost-effectiveness ratio (ICER), expressed as quality-adjusted life-years (QALY), and ICER <¥5 m per QALY gained was judged to be cost-effective. The impact of PCI on cardiovascular events was based on previous publications. In STEMI patients, the ICER of PCI over medical treatment was ¥0.97 m per QALY gained. The cost-effectiveness probability of PCI was 99.9%. In AP patients, the ICER of fractional flow reserve (FFR)-guided PCI over medical treatment was ¥4.63 m per QALY gained. The cost-effectiveness probability of PCI was 50.4%. The ICER of FFR-guided PCI for asymptomatic patients was ¥23 m per QALY gained. CONCLUSIONS: In STEMI patients, PCI was cost-effective compared with medical therapy. In AP patients, FFR-guided PCI for symptomatic patients could be cost-effective compared with medical therapy. FFR-guided PCI for asymptomatic patients with myocardial ischemia was not cost-effective.

Prediction Model for Extended Hospital Stay Among Medicare Beneficiaries After Percutaneous Coronary Intervention.

OBJECTIVE: The authors conducted a retrospective analysis to develop a predictive model consisting of factors associated with extended hospital stay among Medicare beneficiaries undergoing percutaneous coronary intervention (PCI). DESIGN: Retrospective cohort study. SETTING: Multi-institutional. PARTICIPANTS: Data were obtained from the National (Nationwide) Inpatient Sample registry from 2013 to 2014 over a 2-year period. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: The primary outcome was extended hospital stay, which was defined as an inpatient stay greater than 75th percentile for the cohort (≥5 d), among Medicare beneficiaries (fee-for-service and managed care) undergoing PCI. A multivariable logistic regression analysis was built on a training set to develop the predictive model. The authors evaluated model performance with area under the receiver operating characteristic curve (AUC) and performed k-folds cross-validation to calculate the average AUC. The final analysis included 91,880 patients. Inpatient hospital length of stay ranged from 0 to 247 days, with 3 and 5 days as the median and 3rd quartile hospital stay, respectively. The final multivariable analysis suggested that sociodemographic variables, hospital-related factors, and comorbidities were associated with a greater odds of extended hospital stay (all p < 0.05). The use of PCI with drug-eluting stent was associated with a 31% decrease in extended hospital stay (odds ratio 0.69, 95% confidence interval 0.66-0.72; p < 0.001). Model discrimination was deemed excellent with an AUC (95% confidence interval) of 0.814 (0.811-0.817) and 0.809 (0.799-0.819) for the training and testing sets, respectively. CONCLUSION: The authors' predictive model identified risk factors that have a higher probability of extended hospital stay. This model can be used to improve periprocedural optimization and improved discharge planning, which may help to decrease costs associated with PCIs. Management of Medicare beneficiaries after PCI calls for a multidisciplinary approach among healthcare teams and hospital administrators.

Cost utility of fractional flow reserve-guided percutaneous coronary intervention in multivessel coronary artery disease in Brazil.

OBJECTIVE: The fractional flow reserve (FFR) versus angiography for multivessel evaluation (FAME) study has demonstrated that FFR substantially reduces major adverse cardiac events and resource utilization in coronary artery disease (CAD) patients. We aimed to assess the cost utility of FFR in percutaneous coronary interventions (PCI) from the perspective of the Brazilian Public Health System (SUS). DESIGN: Patient-level cost-utility analysis along the FAME study. PARTICIPANTS: Multivessel coronary artery disease patients. INTERVENTION: PCI, either guided by FFR or by angiography alone. SETTING: The procedure costs were based on the mean amount of unitary resource utilization multiplied by the costs from SUS reimbursement list. The utilities were derived using Brazilian weights for time trade-off European Quality of Life-5 Dimensions. The World Health Organization recommendation based on gross domestic product per capita (international dollars [I$] 35 876/quality-adjusted life year [QALY]) was used as willingness-to-pay threshold. MAIN OUTCOME MEASURE: We determined the incremental cost-utility ratio (ICUR) in I$ per QALY gained during the 1-year time horizon. RESULTS: One-year costs were I$ 8931 for the angiography-guided PCI and I$ 8968 for the FFR-guided PCI, resulting in an incremental cost of I$ 37. Effectiveness during 1 year was 0.798 QALYs for angiography-guided PCI and 0.811 for FFR-guided PCI, resulting in an incremental effectiveness of 0.013 QALYs. The base-case ICUR of FFR versus angiography-guided PCI was 2780 I$/QALY. Cost-saving results are achieved with a FFR price reduction of at least 2.2%. CONCLUSIONS: Developing countries should give attention to strategies proven to be cost-effective in other health systems. In our analysis, FFR-guided PCI is very cost-effective in the Brazilian SUS and with a minimal price reduction of the device, FFR could be cost saving.