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Objectives The authors analyzed data from the NCDR (National Cardiovascular Data Registry) PVI Registry and defined acute kidney injury (AKI) as increased creatinine of ≥0.3 mg/dl or 50%, or a new requirement for dialysis after PVI. Background AKI is an important and potentially modifiable complication of peripheral vascular intervention (PVI). The incidence, predictors, and outcomes of AKI after PVI are incompletely characterized. Methods A hierarchical logistic regression risk model using pre-procedural characteristics associated with AKI was developed, followed by bootstrap validation. The model was validated with data submitted after model creation. An integer scoring system was developed to predict AKI after PVI. Results Among 10,006 procedures, the average age of patients was 69 years, 58% were male, and 52% had diabetes. AKI occurred in 737 (7.4%) and was associated with increased in-hospital mortality (7.1% vs. 0.7%). Reduced glomerular filtration rate, hypertension, diabetes, prior heart failure, critical or acute limb ischemia, and pre-procedural hemoglobin were independently associated with AKI. The model to predict AKI showed good discrimination (optimism corrected c-statistic = 0.68) and calibration (corrected slope = 0.97, intercept of −0.07). The integer point system could be incorporated into a useful clinical tool because it discriminates risk for AKI with scores ≤4 and ≥12 corresponding to the lower and upper 20% of risk, respectively. Conclusions AKI is not rare after PVI and is associated with in-hospital mortality. The NCDR PVI AKI risk model, including the integer scoring system, may prospectively estimate AKI risk and aid in deployment of strategies designed to reduce risk of AKI after PVI.

Objectives This study sought to assess periprocedural bleeding complications in lower-extremity peripheral vascular interventions (PVIs). Background Few studies have examined the incidence, predictors, or outcomes of periprocedural bleeding after lower-extremity PVI. Methods The study examined patients undergoing PVI at 76 hospitals in the National Cardiovascular Data Registry PVI registry from 2014 to 2016. Post-PVI major bleeding was defined as any overt bleeding with a hemoglobin (Hb) drop of ≥3 g/dl, any Hb decline of ≥4 g/dl, or blood transfusion in patients with pre-procedure Hb >8 g/dl within 72 h of their procedure. Hierarchical multivariable logistic regression was used to identify factors independently associated with post-PVI bleeding. The study also examined adjusted in-hospital mortality among patients with or without major bleeding complications. Results Among 18,289 PVI procedures, major bleeding occurred in 744 (4.10%). Patient characteristics independently associated with bleeding included age, female sex, heart failure, pre-procedural hemoglobin Conclusions Major bleeding occurred in 4.10% of lower-extremity PVI procedures and was associated with several patient and procedural characteristics, as well as in-hospital mortality. These insights can be incorporated into strategies to reduce periprocedural bleeding after PVI.

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

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 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.

Objectives This study investigates the effects of glycoprotein IIb/IIIa inhibitors (GPIs) on outcomes after percutaneous coronary intervention (PCI). Background Ischemic complications are reduced after PCI when a GPI is added to heparin. However, there are limited data on the safety and efficacy in contemporary PCI. Methods We used the National Cardiovascular Data Registry CathPCI Registry data to assess the association between GPI use and PCI outcomes for acute coronary syndrome between July 2009 and September 2011. The primary outcome was all-cause in-hospital mortality. The secondary outcome was major bleeding. To adjust for potential bias, we used multivariable logistic regression, propensity-matched (PM) analysis, and instrumental variable analysis (IVA). Results There were 970,865 patients included; 326,283 (33.6%) received a GPI. Unadjusted mortality and major bleeding were more common with a GPI (2.4% vs. 1.4% and 3.7% vs. 1.5%, respectively; p Conclusions In unselected acute coronary syndrome patients undergoing PCI, GPI use was associated with reduced in-hospital mortality and increased bleeding. In the modern era of PCI, there may still be a role for the judicious use of GPIs.

Objectives This study compared health-related quality of life in patients undergoing carotid artery stenting (CAS) versus surgical endarterectomy (CEA). Background Carotid artery stenting is approved in the U.S. for treating carotid stenosis in patients at high surgical risk. Whether CAS offers advantages in terms of other patient-centered outcomes is unknown. Methods We evaluated health-related quality of life in the SAPPHIRE (Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy) trial, which randomized 334 high-risk patients with carotid stenosis to CAS versus CEA. Health status assessments were obtained at baseline; 2 weeks; and 1, 6, and 12 months after revascularization. Generic measures included the Short-Form-36 (SF-36) (0 to 100 scale), general health rating, and EuroQol (EQ-5D). In addition, we used 6 disease-specific modified Likert scales to assess difficulty with walking, eating/swallowing, driving, headaches, neck pain, and leg pain. Results In patients treated according to protocol (n = 159 CAS; n = 151 CEA), CAS patients had better scores at 2 weeks for the SF-36 role physical scale (mean difference: 9.0; 95% confidence interval: 0.9 to 17.1; p = 0.031), but these differences had resolved by 1-month follow-up. For the disease-specific scales, CAS patients reported less difficulty eating/swallowing at 2 weeks, less difficulty driving at 2 weeks, and less neck pain at 2 weeks; each of these differences between groups was no longer present at 1 month. No other scores differed between groups at any time point. Conclusions Among patients at high surgical risk, CAS was associated with less health status impairment during the first 2 weeks of recovery when compared with CEA. However, these differences had resolved by 1 month after the procedure, and no other differences between revascularization strategies in health-related quality of life were found.

ObjectivesThis study sought to evaluate the costs of transradial percutaneous coronary intervention (TRI) and transfemoral percutaneous coronary intervention (TFI) from a contemporary hospital perspective.BackgroundWhereas the TRI approach to percutaneous coronary intervention (PCI) has been shown to reduce access-site complications compared with TFI, whether it is associated with lower costs is unknown.MethodsTRI and TFI patients were identified at 5 U.S. centers. The primary outcome was the cost of percutaneous coronary intervention (PCI) hospitalization, defined as cost on the day of PCI through hospital discharge. Cost was obtained from each hospital’s cost accounting system. Independent costs of TRI were identified using propensity-scoring methods with inverse probability weighting. Secondary outcomes of interest were bleeding, in-hospital mortality, and length of stay, which were stratified by pre-procedural risk and PCI indication.ResultsIn 7,121 PCI procedures performed from January 1, 2010, to March 31, 2011, TRI was performed in 1,219 (17%) patients and was associated with shorter lengths of stay (2.5 vs. 3.0 days; p

Objectives This study compared the survival benefit of opening a chronic total occlusion (CTO) of the left anterior descending (LAD), left circumflex (LCX), or right coronary artery (RCA). Background Previous analyses demonstrate improved survival following successful percutaneous coronary intervention (PCI) for CTO. Methods Eligible patients underwent attempted CTO PCI in a single vessel. Procedural success rates were calculated for each vessel. The primary end point was survival at 5 years, compared across target vessel groups stratified by procedural success. Results There were 2,608 patients included. The LAD was the target vessel in 936 (36%), the LCX in 682 (26%), and the RCA in 990 (38%) patients. Angiographic success rates for LAD were 77%, LCX 76%, and RCA 72%. Baseline demographics and comorbidities were well matched, though there were significantly more males in the LCX compared with LAD or RCA groups (80% vs. 75% and 73%, respectively, p = 0.005). Procedural success compared with failure was associated with improved 5-year survival in the LAD (88.9% vs. 80.2%, p l 0.001) group, but not in the LCX (86.1% vs. 82.1%, p = 0.21) and RCA groups (87.7% vs. 84.9%, p = 0.23). In multivariable analysis, CTO PCI success in the LAD group remained associated with decreased mortality risk (HR: 0.61, 95% CI: 0.42 to 0.89). Conclusions The data suggest that PCI for CTO of the LAD, but not LCX or RCA, is associated with improved long-term survival. This information may assist in selecting patients for attempted CTO PCI.