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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.

Background Improvement of symptoms and functional status is one of the main peripheral artery disease (PAD) treatment goals but pharmacological options are limited. The objective of this study was to assess the use of cilostazol and its association with patient-reported health status quantified by the Peripheral Artery Questionnaire (PAQ). Methods Initiation of cilostazol therapy was assessed in 567 patients in the US cohort of PORTRAIT between June 2011 and December 2015. Patients with heart failure history, on cilostazol prior to enrollment, with no baseline or follow-up PAQ scores were excluded. Health status over time was quantified using linear mixed models adjusting for baseline PAQ scores and patient characteristics. Results Of the 567 cilostazol-naive patients, 65 (11%) were started on cilostazol. Mean age was 68.5 ± 9.6 years, 43% were female and 71.1% white. There was no significant difference in the mean PAQ score changes from baseline to 12 months between the cilostazol and non-cilostazol group, with difference of 3.8 [CI (−2.6, 10.1), p = .24] for summary scores, 1.6 [CI (−5.5, 8.6), p = .66] for quality of life, 3.6 [CI (−4.3, 11.6), p = .37] for symptoms, 6.2 [CI (−3.1, 15.5), p = .19] for physical limitation and 3.2 [CI (−3.9, 10.2), p = .38] for social limitation scores. Conclusions We found a low rate of cilostazol use and while there was no significant association between cilostazol initiation and subsequent health status, the ability to define small differences in health status was limited due to the small sample size.

OBJECTIVES To develop a model to predict risk of in-hospital bleeding following endovascular peripheral vascular intervention. BACKGROUND Peri-procedural bleeding is a common, potentially preventable complication of catheter-based peripheral vascular procedures and is associated with increased mortality. We used the National Cardiovascular Data Registry (NCDR) Peripheral Vascular Interventions (PVI) Registry to develop a novel risk-prediction model to identify patients who may derive the greatest benefit from application of strategies to prevent bleeding. METHODS We examined all patients undergoing lower extremity PVI at 76 NCDR PVI hospitals from 2014 to 2017. Patients with acute limb ischemia (n = 1600) were excluded. Major bleeding was defined as overt bleeding with a hemoglobin (Hb) drop of ≥ 3 g/dl, any Hb decline of ≥ 4 g/dl, or a blood transfusion in patients with pre-procedure Hb ≥ 8 g/dl. Hierarchical multivariable logistic regression was used to develop a risk model to predict major bleeding. Model validation was performed using 1000 bootstrapped replicates of the population after sampling with replacement. RESULTS Among 25,382 eligible patients, 1017 (4.0%) developed major bleeding. Predictors of bleeding included age, female sex, critical limb ischemia, non-femoral access, prior heart failure, and pre-procedure hemoglobin. The model demonstrated good discrimination (optimism corrected c-statistic = 0.67), calibration (corrected slope = 0.98, intercept of -0.04) and range of predicted risk (1%-18%). CONCLUSIONS Post-procedural PVI bleeding risk can be predicted based upon pre- and peri-procedural patient characteristics. Further studies are needed to determine whether this model can be utilized to improve procedural safety through developing and targeting bleeding avoidance strategies.

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.

Patients with peripheral artery disease (PAD) face a range of treatment options to improve survival and quality of life. An evidence-based shared decision-making tool (brochure, website, and recorded patient vignettes) for patients with new or worsening claudication symptoms was created using mixed methods and following the International Patient Decision Aids Standards (IPDAS) criteria. We reviewed literature and collected qualitative input from patients ( n = 28) and clinicians ( n = 34) to identify decisional needs, barriers, outcomes, knowledge, and preferences related to claudication treatment, along with input on implementation logistics from 59 patients and 27 clinicians. A prototype decision aid was developed and tested through a survey administered to 20 patients with PAD and 23 clinicians. Patients identified invasive treatment options (endovascular or surgical revascularization), non-invasive treatments (supervised exercise therapy, claudication medications), and combinations of these as key decisions. A total of 65% of clinicians thought the brochure would be useful for medical decision-making, an additional 30% with suggested improvements. For patients, those percentages were 75% and 25%, respectively. For the website, 76.5% of clinicians and 85.7% of patients thought it would be useful; an additional 17.6% of clinicians and 14.3% of patients thought it would be useful, with improvements. Suggestions were incorporated in the final version. The first prototype was well-received among patients and clinicians. The next step is to implement the tool in a PAD specialty care setting to evaluate its impact on patient knowledge, engagement, and decisional quality. ClinicalTrials.gov Identifier: NCT03190382

Background: The American College of Cardiology/American Heart Association Appropriate Use Criteria were designed to aid clinical decision-making, yet their association with health status outcomes after chronic total occlusion percutaneous coronary intervention (PCI) is unknown. Methods: We analyzed 769 patients with baseline and 1-year health status data after chronic total occlusion PCI. Procedures were categorized as appropriate, may be appropriate, or rarely appropriate. Mean changes in patient-reported health status, assessed by the Seattle Angina Questionnaire (SAQ), were compared across appropriate use criteria categories from baseline to 1 year. Change in SAQ summary score was stratified as little to no benefit (≤10 points), intermediate (10–19 points), large (20–29 points), and very large (≥30 points). Results: The appropriate use criteria indication was appropriate in 573 patients (74.5%), may be appropriate in 191 (24.8%), and rarely appropriate in 5 (0.7%). Patients in the appropriate group reported greater improvement in SAQ summary scores (27.3±21.3 points) at 1 year compared with the may be appropriate (22.5±20.9; P =0.01). A similar pattern was noted for SAQ angina frequency (mean change 24.0±27.2 versus 18.7±25.6; P =0.02). The appropriate group had the highest proportion of very large improvements in SAQ summary scores (44.5% versus 33.3%; P =0.01). Conclusions: Among patients undergoing chronic total occlusion PCI, the rate of rarely appropriate PCI was low. The rate of appropriate PCI was high and was associated with the greatest health status improvement at 1 year. A substantial proportion of patients in the may be appropriate group experienced meaningful health status benefits as well.

Background Underuse of guideline‐recommended therapy in peripheral artery disease ( PAD ) in administrative and procedural databases has been described, but reports on medically managed patients and referral to supervised exercise therapy ( SET ) in PAD are lacking. We aimed to document the use of PAD guideline‐recommended therapy, including SET in patients with PAD symptoms consulting a specialty clinic across 3 countries. Methods and Results The 16‐center PORTRAIT (Patient‐Centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories) registry enrolled 1275 patients with new or an exacerbation of PAD symptoms (2011–2015). We prospectively documented antiplatelet medications, statins, smoking cessation counseling and/or therapy, and referral to SET : “2 quality measures” referred to the use of both statin and antiplatelet medications; “4 quality measures” to receiving all 4 measures. Median odds ratios were calculated to quantify treatment variation across sites. A total of 89% patients were on antiplatelets, 83% on statins, and 23% had been referred to SET . Of 455 current smokers, 342 (72%) patients received smoking cessation therapy/counseling. Overall, 77.2% of patients received “2 quality measures” and 19.7% “4 quality measures.” The median odds ratio for 2 quality measures was 2.13 (95% CI , 1.61–3.56; P CI , 2.84–17.91; P SET . The odds for SET referral in The Netherlands (70% referral rate) was nearly 100 times greater than in US sites (2% referral rate). Conclusions Not all patients who have undergone a PAD workup at a specialty care facility are treated with evidence‐based care, especially so for SET .

Background The ACC/AHA cholesterol guidelines recommend patients with peripheral artery disease (PAD) be treated with a moderate to high-intensity statin. The extent to which patients with new or worsening PAD symptoms are offered guideline therapy is unknown. Hypothesis There is significant variability in rate of guideline-directed statin intensification across clinical practices. Methods In the PORTRAIT registry, patterns of statin therapy were assessed in 1144 patients at 16 PAD specialty clinics between June 2011 and December 2015 before and after an evaluation for new or worsening claudication symptoms. We documented whether patients were treated with a guideline statin as well as the incidence of statin intensification. Statin intensification was defined as transitioning from no statin or low-intensity statin to moderate or high-intensity statin treatment. Patient factors associated with intensification were examined. Site and provider-level variation in intensification was summarized using an adjusted median odds ratio (aMOR). Results Among 1144 patients, 810 (70.8%) were initially on guideline therapy compared to 334 (29.2%) that were not. In the latter, 103 (30.8%) received intensification following evaluation. Patients with typical symptoms displayed greater odds of intensification (OR 3.74; 95% CI: 1.23-11.41) while older patients had lower odds of intensification (OR 0.60/decade; 95% CI: 0.41-0.88). Site variability for statin intensification was observed across sites (aMOR = 3.15; 95% CI 1.22-9.60, [P = 0.02]) but not providers (aMOR = 1.89; 95% CI 1.00-3.90, [P = 0.14]). Conclusions Most patients evaluated at a PAD specialty clinic for new or worsening claudication symptoms arrived on guideline statin therapy. Only 31% not receiving appropriate therapy underwent statin intensification. These findings highlight an important opportunity to optimize medical therapy for patients with PAD.

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.

Purpose To determine differences in donor transmitted atherosclerosis or rapidly progressive Cardiac Allograft Vasculopathy at 1-year post cardiac transplantation in patients with congenital heart disease. Methods This is a retrospective study of patients who underwent heart transplantation at a single center from 2009-2016 who had subsequent coronary angiography with protocol-driven IVUS assessment of the left anterior descending artery. Non-congenital cardiac transplantation patients (N=237) were compared to a cohort of patients with adult congenital heart disease (N=12). Five IVUS sections were prospectively analyzed for intimal thickness. Donor transmitted atherosclerosis was defined as maximum intimal thickness ≥0.5 mm at baseline and rapidly progressive CAV as an increase in maximum intimal thickness by ≥0.5 mm at 1-year. Results Donor transmitted atherosclerosis was present in 121 (51.1%) patients with non-congenital etiology vs. 7 (58.3%) patients with congenital etiology. Rapidly progressive CAV at 1-year post-transplantation was present in 54 (23.0%) vs. 2 (18.2%) patients, respectively. Over a median follow up of 6.1 years, 39 patients died or required re-transplantation. ACHD as an etiology of heart failure was not associated with age- and sex-adjusted outcomes. In a subsequent analysis, there were 45 patients who reached a composite outcome of coronary revascularization, epicardial CAV, or cardiovascular death. Likewise, there was no association between ACHD and this composite endpoint. Conclusion Pre-transplant adult congenital heart disease was not associated with a significant difference in donor transmitted atherosclerosis or rapidly progressive CAV in patients with heart transplantation. Long term outcomes including all-cause mortality and cardiovascular events were not different in patients with versus without ACHD.

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 To explore the association of health status change and long-term survival among patients with symptomatic peripheral artery disease (PAD). Background Early gains in health status after successful endovascular therapy (EVT) for symptomatic PAD can be maintained up to 1 year. Whether such health status improvements are associated with long-term survival benefits is unknown. Methods Between February 2001 and August 2004, 258 patients with symptomatic PAD treated with EVT participated in a prospective study evaluating baseline and 1 year health status using the Peripheral Artery Questionnaire (range 0–100, higher scores = better). All-cause mortality was assessed for all patients at a median of 9.4 years following EVT. Results The mean age at enrollment was 68 ± 11 years; 61% were male, 97% were Caucasian, and 38% had diabetes. Patients with a clinically meaningful health status improvement (≥8 points) 1 year after their index procedure (79%) were identified as responders. Responders had a significantly better 10 year survival compared with nonresponders (60% vs 38%, p = 0.025). Responder status was associated with a survival advantage that persisted in risk-adjusted analysis (adjusted hazard ratio for long-term mortality, 0.66 [95% CI, 0.45–0.97]; p = 0.036). Conclusions Among patients with symptomatic PAD undergoing EVT, improvement of PAD-specific health status at 1 year follow-up was associated with improved long-term survival. Whether additional treatment for patients with poor response to EVT could improve long-term survival warrants further investigation. © 2016 Wiley Periodicals, Inc.

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.

The authors performed a multicenter, randomized-controlled, clinical trial comparing upfront use of the CrossBoss catheter versus antegrade wire escalation for antegrade crossing of coronary chronic total occlusions.There is equipoise about the optimal initial strategy for crossing coronary chronic total occlusions.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 use.Between 2015 and 2017, 246 patients were randomized to the CrossBoss catheter (n = 122) or wire escalation (n = 124) at 11 U.S. 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 2 groups. Crossing time was similar: 56 min (interquartile range: 33 to 93 min) in the CrossBoss group and 66 min (interquartile range: 36 to 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.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 use and cost.

OBJECTIVES To evaluate the clinical and health status outcomes of patients undergoing superficial femoral artery (SFA) revascularization using the Shape Memory Alloy Recoverable Technology (S.M.A.R.T.®) nitinol self-expanding stent through 3 years of follow-up. BACKGROUND Limited long-term data are available describing the durability of benefits after femoropopliteal revascularization. METHODS In a multicenter, prospective, core-lab adjudicated study, 250 subjects with de novo or restenotic femoropopliteal arterial lesions were treated with the S.M.A.R.T.® stent. The primary endpoint of target vessel patency, a composite of ultrasound-assessed patency and freedom from clinically driven target lesion revascularization (TLR), was evaluated through 3 years. Secondary endpoints included stent fracture and health status. Health status was measured using generic and disease-specific instruments, including the Peripheral Artery Questionnaire (PAQ). RESULTS At 3-year follow-up, Kaplan-Meier estimated target vessel patency was 72.7%, freedom from clinically driven TLR was 78.5%, and the incidence of stent fracture was 3.6%. The PAQ summary score was markedly impaired at baseline (mean 37.3 ± 19.6 points) and improved substantially at 1 month (mean change from baseline of 31.4 points, 95% CI: 28.5-34.3; P

The prevalence of radial access for transradial catheterization remains low in the United States, occurring in only 28% of cases in the National Cardiovascular Data Registry (NCDR) CathPCI. It is unknown whether the low adoption rate has been influenced by patient characteristics or is more operator dependent. In a 10-center study, we compared clinical and demographic characteristics among 323 radial and 1,506 femoral access percutaneous coronary intervention (PCIs) performed by 65 interventionists capable of radial PCI. We created a hierarchical logistic regression model to identify operator and patient characteristics associated with radial PCI and the median rate ratio to quantify the variation across operators. A subset was interviewed to assess health literacy and preferences in shared medical decision making. Radial access was used in 17.7% of patients. Patient factors associated with lower rate of radial PCI were previous PCI (33.4% vs 41.4%, p = 0.008), history of coronary artery bypass graft (8.4% vs 23.0%, p

Purpose Among patients who undergo orthotopic heart transplant (OHT), intravascular ultrasound (IVUS) detection of coronary allograft vasculopathy (CAV), defined as ≥ 0.5 mm increase in maximal intimal thickness (Δ MIT), is associated with worse outcomes at 5 years. Other IVUS-derived measurements of arterial plaque, while validated in studies of coronary atherosclerosis, have not been well studied in CAV. Methods From a single-center registry of 279 patients who underwent OHT from 1/09-1/16, a cohort of 10 randomly selected patients who experienced a cardiac event (defined as myocardial infarction or need for percutaneous coronary intervention) within 36 months post-OHT was compared with a control group of 10 randomly selected patients without post-OHT cardiac events. As a proof of concept analysis, IVUS data from baseline & 1 year were assessed to determine evidence of CAV development by Δ MIT & to measure change in Percent Atheroma Volume (PAV) & Total Atheroma Volume Normalized (TAVN). Presence of CAV by Δ MIT & median differences in PAV & TAVN were tested for association with cardiac events, using appropriate univariate statistics. Results Of 20 total patients, 30% were female, and median (IQR) age was 52.5 (42.5, 60.5) years. More patients in the non-event group had CAV at 1 year based on Δ MIT (4 vs. 3). Presence of CAV by Δ MIT & change in TAVN at 1 year were not significantly associated with cardiac events. However, a significant difference in PAV was present in patients within the event cohort, compared to the non-event cohort (median % change [IQR] = 7.6 [1.5, 10.9] vs. 0.6 [0.2, 4.8], p=0.049) (Table). Conclusion While increase in MIT at 1 year predicts worse outcomes at 5 years among patients after OHT, this retrospective proof of concept analysis suggests that PAV could have a stronger association with cardiac events than MIT or TAVN. Further studies are needed to investigate the accuracy & predictive utility of PAV as a measure of total allograft plaque burden.

Objectives We aimed to compare quality of life benefits of percutaneous coronary intervention (PCI) for chronic total occlusions (CTO) with non-CTO PCI. Background Data quantifying the benefits of PCI of CTO are inconsistent. Methods We leveraged a 10-center prospective PCI registry including Seattle Angina Questionnaire (SAQ) assessment at the time of PCI and in follow-up. We propensity matched attempted CTO PCIs with up to 10 non-CTO PCIs. The primary analysis compared changes between baseline and 6 months in SAQ Physical Limitation (PL), Quality of Life (QoL); Angina Frequency (AF) scores as well as the Rose Dyspnea scores (RDS) and the EQ5D Visual Analogue Scale (VAS). Noninferiority was assessed for quality of life changes between CTO and non-CTO PCI. Results In 3,303 patients enrolled, 167 single-vessel CTOs were attempted; 147 (88%) were matched with 1,616 non-CTO PCI. Baseline PL (73.0 vs. 77.4, P = 0.039) and VAS (66.4 vs. 70.8, P = 0.005) scores were lower for CTO. There was no difference in AF, QoL, or RDS scores. At 6-month follow-up, all SAQ scores improved (P

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.

To explore the association of health status change and long-term survival among patients with symptomatic peripheral artery disease (PAD).Early gains in health status after successful endovascular therapy (EVT) for symptomatic PAD can be maintained up to 1 year. Whether such health status improvements are associated with long-term survival benefits is unknown.Between February 2001 and August 2004, 258 patients with symptomatic PAD treated with EVT participated in a prospective study evaluating baseline and 1 year health status using the Peripheral Artery Questionnaire (range 0-100, higher scores = better). All-cause mortality was assessed for all patients at a median of 9.4 years following EVT.The mean age at enrollment was 68 ± 11 years; 61% were male, 97% were Caucasian, and 38% had diabetes. Patients with a clinically meaningful health status improvement (≥8 points) 1 year after their index procedure (79%) were identified as responders. Responders had a significantly better 10 year survival compared with nonresponders (60% vs 38%, p = 0.025). Responder status was associated with a survival advantage that persisted in risk-adjusted analysis (adjusted hazard ratio for long-term mortality, 0.66 [95% CI, 0.45-0.97]; p = 0.036).Among patients with symptomatic PAD undergoing EVT, improvement of PAD-specific health status at 1 year follow-up was associated with improved long-term survival. Whether additional treatment for patients with poor response to EVT could improve long-term survival warrants further investigation. © 2016 Wiley Periodicals, Inc.

Background The goal of treatment for lower extremity peripheral artery disease is often to improve health status. Factors associated with failure to improve are unknown. Methods Health status was assessed with the Peripheral Artery Questionnaire (PAQ) at baseline and 2 years in 344 patients referred to vascular clinics. Improvement was defined as an increase of ≥5 points on the PAQ Summary Score. Multivariable logistic regression identified patient and treatment characteristics associated with impaired baseline health status, and predictors of no improvement ( Results Older age, bilateral symptoms, female sex and prior revascularization were associated with impaired baseline health status. At 2 years 36% reported unimproved health status. Factors associated with no improvement were older age (Odds Ratio 1.67/decade, CI 1.28, 2.19), better baseline health status (OR 1.40/10-points, CI 1.24, 1.59), beta blocker use (OR 2.53, CI 1.37, 4.68), prior stroke (OR 4.12, CI 1.33, 12.77) and bilateral claudication (OR 1.79, CI 1.07, 2.99). Summary Older patients, women, and those with bilateral symptoms or prior revascularization have worse health status at vascular referral. Over 1/3 of patients’ health status did not improve over 2 years; older patients and those with bilateral or milder symptoms, prior stroke or using beta blockers were less likely to improve.

Depressive symptoms are known to compromise health status in cardiac disease, but this relationship has not been described in peripheral artery disease (PAD). Depressive symptoms (PHQ-9) and disease-specific health status (Peripheral Artery Questionnaire, PAQ) were assessed in 242 PAD patients undergoing percutaneous transluminal angioplasty (PTA) at baseline and 1 year. Patients were classified by baseline and follow-up depression status (moderate–severe depressive symptoms = PHQ ≥ 10). Changes were categorized as no depression/improvement of depression versus persistent/worsened depression. At baseline, 20% of patients were depressed; at 1 year, 17% of patients experienced persistent/worsened depression. Although this group improved on most PAQ subscales, they improved to a significantly lesser degree than those without depressive symptoms or those who improved by 1 year ( p-values < 0.05). Baseline depressive symptoms (Bper 5-point increment = −11.9, 95% CI −15.3, −8.5, p < 0.0001) and changes in depression were independently associated with a decrease in 1-year health status (Bper 5-point increment = −11.7, 95% CI −14.3, −9.2, p < 0.0001). In conclusion, depressive symptoms are associated with less improvement in health status 1 year after undergoing a peripheral endovascular revascularization (PER) as compared with those having no depression or whose depressive symptoms improve. Efforts to improve depression detection and treatment among patients with PAD may improve the health status outcomes of these patients.

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.

This study investigates the effects of glycoprotein IIb/IIIa inhibitors (GPIs) on outcomes after percutaneous coronary intervention (PCI).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.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).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 0.001 for both). In contrast, GPI use was associated with lower mortality on adjusted analyses; relative risks range from 0.72 (95% confidence interval [CI]: 0.50 to 0.97) with IVA to 0.90 (95% CI: 0.86 to 0.95) with PM. The association of GPI use with bleeding remained in adjusted analyses (multivariable relative risk: 1.93, 95% CI: 1.83 to 2.04; PM relative risk: 1.83, 95% CI: 1.74 to 1.92; and IVA relative risk: 1.53, 95% CI: 1.27 to 2.13). Subgroup analysis revealed enhanced risk reduction with ST-segment elevation myocardial infarction, high predicted mortality, and heparin-based anticoagulation.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.

The objectives of this study were to evaluate angiographic and clinical outcomes among patients with diabetes mellitus (DM) who underwent percutaneous coronary intervention (PCI) for a chronic total occlusion (CTO). We compared them with matched patients undergoing PCI of a non-CTO lesion. All patients had documented DM. Matching was performed using a propensity score for CTO. There were 506 patients with DM and CTO who were matched with a non-CTO group. Results showed that angiographic success rates were lower with CTO (75% vs. 93%, p We conclude that PCI of CTO is safe in patients with DM. Angiographic failure is not associated with an increase in MACE rates or mortality as compared to matched nonCTO patients. However, there is not a measurable improvement in survival in this DM-CTO population.

ObjectivesThe goal of this study was to compare health status (symptoms, function, and quality of life) outcomes of whites and blacks one year after an acute coronary syndrome (ACS).BackgroundAlthough racial differences in the use of angiography and revascularization after ACS are known to exist, differences in health status outcomes have not been described.MethodsWe conducted a prospective registry of 1,159 consecutive ACS patients treated between February 1, 2000 and October 31, 2001. One-year health status was quantified with the Seattle Angina Questionnaire (SAQ) and Short Form-12 Physical Component Score (SF-12 PCS). Multivariable models were used to adjust for racial differences in sociodemographic, clinical, and treatment characteristics.ResultsMortality rates were similar among the 196 black and 963 white patients (7.1% vs. 7.0%, p = 0.93); 81 died during follow-up, and 199 (17%) could not be interviewed. At one year, blacks had a higher prevalence of angina (43.4% vs. 27.1%), worse quality of life (SAQ score = 70.6 ± 28.3 vs. 83.9 ± 20.8), and poorer physical function (SF-12 PCS = 36.8 ± 12.3 vs. 43.2 ± 11.4; p < 0.0001 for all). Multivariable models, including hospital treatments, revealed a trend for more angina (odds ratio 1.46 [95% confidence interval 0.91 to 2.34]) and significantly worse quality of life (mean difference = −7.7 ± 2.4, p = 0.002) and physical function (−3.6 ± 1.3, p = 0.005).ConclusionsBlacks have more angina, worse quality of life, and worse physical function one year after an ACS than do whites. Closer surveillance of black ACS patients is needed to determine whether additional treatment can improve their outcomes.

There are few data concerning the relationship between diabetes mellitus, the metabolic syndrome and inflammation following elective percutaneous coronary intervention (PCI). The purpose of this study was to assess basal and peak levels of candidate cytokines in 40 patients undergoing elective PCI. Patients were categorised as having diabetes mellitus, the metabolic syndrome, or neither. Patients with the metabolic syndrome exhibited significantly greater levels of tumour necrosis factor-a over the study period, although this was unrelated to PCI. There was a trend for increased levels of interleukin-6 following PCI, primarily among patients with metabolic syndrome. Basal levels of monocyte chemoattractant protein-1 (MCP-1) were not different among study groups; however, the metabolic syndrome cohort had a trend towards increased circulating levels of MCP-1 after PCI. In this patient population, the metabolic syndrome correlates with a heightened inflammatory response following elective PCI.

One-year health status improvements in 62 patients with previous coronary artery bypass grafting (CABG) were compared with those of 628 patients undergoing initial CABG using the Seattle Angina Questionnaire (SAQ). Adjusted analyses revealed that repeat CABG conferred similar 1-year improvements in health status compared with patients undergoing a first CABG (changes in SAQ Physical Limitation score [SAQ-PL: repeat CABG 25 +/- 27 vs first CABG 20 +/- 27; p = 0.30], Quality of Life score [SAQ-QoL: 34 +/- 24 vs 35 +/- 5; p = 0.87], and Angina Frequency score (SAQ-AF: 35 +/- 40 vs 25 +/- 24; p = 0.03]).

Coronary chronic total occlusion (CTO) has been associated with worse long-term outcomes among patients with acute myocardial infarction (AMI) undergoing percutaneous coronary intervention (PCI). Data regarding the association of CTO with in-hospital outcomes in patients with AMI undergoing PCI is

Background: The ACC/AHA Appropriate Use Criteria (AUC) were designed to aid clinical decision-making, yet their association with health status outcomes after CTO PCI is unknown. Methods: We enrolled 1,000 patients undergoing CTO PCI in the 12-center OPEN CTO registry. 52 patients were excluded due

A 30-year-old female with Ehlers–Danlos syndrome and prior right iliac dissection treated with covered stent placement in 2005 presented with acute severe left leg pain. It began with arising from bed and was exacerbated by left hip flexion. Initial evaluation with arterial Duplex imaging revealed evidence of dissection extending from the proximal left common iliac artery to the proximal left superficial femoral artery. Computed tomographic (CT) angiography was performed and confirmed dissection with aneurysmal dilatation of the left common iliac artery to 2.0 × 1.7 cm (Panel A). The patient required intravenous narcotics and was admitted for pain control. A repeat CT angiogram four days later revealed further dilation of the left common iliac artery to 2.4 × 2.0 cm and new aneurysmal dilatation of the proximal left superficial femoral artery (Panel B). Owing to the growth of the aneurysm a third CT angiogram was obtained two days later. This revealed rapid expansion of the common iliac artery aneurysm to 3.3 × 2.7 cm as well as expansion of the proximal superficial femoral artery aneurysm (Panel C).

Methods: We developed a decision-analytic model of costs and bleeding events of transradial vs. transfemoral PCI using inputs from 4 hospitals, and direct PCI costs from each hospital’s respective cost accounting system. Independent costs of radial PCI, urgent vs. elective PCI indication and bleeding complications were identiied by a linear regression model and used as model inputs. The eficacy measure was major bleeding as deined by the NCDR.

Objectives: We assessed the potential for percutaneous coronary intervention (PCI) of a chronic total occlusion (CTO) to decrease myocardial ischemia and established objective criteria to predict post-procedure improvement. Background: Optimal treatment for CTO of coronary arteries is controversial, and selection criteria for PCI of CTO are subjective. Methods: All patients undergoing CTO PCI at a single center between 2002 and 2007 were included if myocardial perfusion imaging (MPI) was performed within 12 ± 3 months before and a follow-up study within 12 ± 3 months after PCI. Average summed difference scores were calculated and converted to percent ischemic myocardium to classify patients as having normal/minimal, mild, moderate, or severe ischemia. A significant improvement in ischemia following PCI was classified as an absolute ≥5% decrease in ischemic myocardium. Receiver operating characteristic (ROC) curves were used to identify ischemic thresholds predictive of decreased and increased ischemic burden on follow-up MPI. Results: In 301 patients, average baseline ischemic burden was 13.1% ± 11.9% and decreased to 6.9% ± 6.5% (P < 0.001) during follow-up. Overall, 53.5% of patients met criteria for improvement following PCI. These patients were more likely to be male, without diabetes, with CTO in the left anterior descending artery, and classified as having high ischemic burden at baseline. ROC analysis identified a baseline 12.5% ischemic burden as optimal in identifying those most likely to have a significantly decreased ischemic burden post-PCI. Those with a baseline ischemic burden less than 6.25% were more likely to have an increased ischemic burden post-PCI. Conclusions: Ischemic burden is reduced following CTO PCI, and the decrease is greater at high ischemic burden. A threshold of 12.5% ischemic burden is suggested as a criterion for performing PCI in the setting of CTO. © 2011 Wiley-Liss, Inc.

Arterial closure devices (ACDs) provide immediate hemostasis, improve comfort, and allow early ambulation after percutaneous coronary intervention (PCI). The aim of this study was to evaluate ACD utilization and post-PCI major bleeding in an unselected cohort. Patients receiving ACDs were propensity matched to those with manual compression to evaluate a primary end point of National Cardiovascular Data Registry (NCDR) major bleeding and a secondary end point of major bleeding stratified by previously developed NCDR bleeding risk categories. Bleeding events that required transfusion, prolonged hospital stays, and/or decreases in hemoglobin ≥3.0 g/dl were included. Length of stay, defined as days after PCI until discharge, was also evaluated. Secondary analysis of bleeding and complication rates between ACD types (suture vs collagen plug) was performed. Five thousand four hundred twenty-one patients underwent PCI, and 2,324 patients (43%) were included in the final propensity matching: 1,162 with ACDs and 1,162 manual compression patients. Major bleeding was reduced in ACD patients compared to those with manual compression (2.4% vs 5.2%, p0.001), and NCDR high-risk patients receiving ACDs had the greatest reduction in major bleeds (3.1% vs 10.3%, p0.001). Length of stay (1.9 ± 1.9 vs 2.3 ± 5.3 days, p = 0.007) and pseudoaneurysms (0.3% vs 1.1%, p = 0.028) were decreased in ACD patients. Suture-based devices revealed a lower composite event rate than collagen-plug ACDs (1.4% vs 3.4%, p = 0.048). In conclusion, ACD use is associated with reductions in NCDR major bleeding, length of stay, and pseudoaneurysms in PCI patients.

Atherectomy has emerged as an alternative to percutaneous transluminal angioplasty (PTA) for endovascular reopening. Despite increasing use of atherectomy (and higher cost of atherectomy catheters compared with balloon catheters), few studies have compared outcomes and costs with other reopening strategies.We performed a retrospective cohort study involving all patients undergoing isolated femoropopliteal PTA (n=69) or atherectomy (n=92) at our institution from 1/2005 to 4/2006. The choice of reopening strategy was left to the treating physician, and no patients with relative contraindications to stent placement (specifically common femoral artery lesions) were included. Device and supply costs were calculated using the hospital resource-based accounting system, and other costs were calculated using the hospital micro-cost accounting system. Professional fees were calculated from the Medicare Fee Schedule.Baseline characteristics were generally well matched. There were no significant differences in complications (vascular complications, urgent repeat reopening, death, myocardial infarction, or stroke) between groups (PTA 8.7% vs. atherectomy 5.4%, P=.53). PTA required more balloons (2.0±0.8 vs. 0.7±1.0, P.001) and stents (1.5±0.8 vs. 0.2±0.5, P.001), but fewer atherectomy catheters (0.0±0.0 vs. 1.2±0.4, P.001). Neither procedural supply costs (PTA $3137±1459 vs. atherectomy $3338±1505, P=.20) nor total costs differed between PTA and atherectomy patients ($10,945±4521 vs. $10,783±3857, P=.42).Initial outcomes and costs are comparable for femoropopliteal PTA and atherectomy. The choice of reopening strategy should therefore be based on operator experience and anatomic suitability. Further studies are required to determine whether there are differences in long-term outcomes or costs between these approaches.

This study compared health-related quality of life in patients undergoing carotid artery stenting (CAS) versus surgical endarterectomy (CEA).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.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.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.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.

We evaluated the efficacy and safety of elective percutaneous coronary intervention (PCI) at a hospital without onsite cardiac surgery. A growing number of hospitals without onsite cardiac surgery perform elective PCI. Few hospitals have reported outcomes, despite controversy surrounding this practice. From August 2003 to December 2005, 1,090 elective PCI were performed at Saint Luke’s South Hospital (SLS), a hospital without onsite cardiac surgery, for which the referral center is the Mid America Heart Institute (MAHI). The elective PCI program used experienced interventionalists, technicians, and nurses; a tested helocopter transport protocol; a well-equipped catheterization laboratory; and a quality assurance process. Baseline characteristics, procedural success, and adverse clinical outcomes were compared. Observed frequencies of in-hospital death, a combined end point of Q-wave myocardial infarction (MI)/emergency coronary artery bypass grafting (CABG) surgery, and vascular complications were compared with prediction models. SLS, with lower risk characteristics than MAHI, had unadjusted frequencies of procedural success (93% vs 94%, p = NS), Q-wave MI (0.3% vs 0.3%, p = NS), emergency CABG surgery (0.2% vs 0.03%, p = 0.09), vascular complications (0.6% vs 0.6%, p = NS), and in-hospital death (0.1% vs 0.8%, p = 0.002) that compared favorably with MAHI. Two patients transferred from SLS to MAHI for emergency CABG surgery without adverse effects. Fewer in-hospital deaths and vascular complications were observed at SLS than predicted by models. In conclusion, favorable clinical outcomes were achieved for elective PCI at a hospital without onsite cardiac surgery that used strict program requirements.

Background— Patients with peripheral arterial disease often undergo peripheral endovascular revascularization (PER) to alleviate symptoms. Despite the growth of PER, little information exists quantifying the health status benefits after the procedure. Methods and Results— From February 2001 to August 2004, 477 consecutive patients underwent PER for symptomatic peripheral arterial disease. Of these, 300 consented to participate in a longitudinal follow-up study of their health status. Health status was quantified with the disease-specific Peripheral Artery Questionnaire and the generic Short Form-12 and the EuroQol 5 Dimensions (EQ5D)questionnaire. Scores range from 0 to 100; higher scores represent fewer symptoms and better health status. The average age of the cohort was 68±11 years (mean±SD); 186 (62%) were male, 288 (96%) were white, and 118 (39%) were diabetic. Clinical follow-up was attained in 99% of patients; health status assessments were made in 86%. Mean Peripheral Artery Questionnaire summary scores improved significantly after revascularization from 31±19 to 62±27 at 1 year ( P P P =0.09). Conclusions— For most patients, significant and sustained improvements in symptoms, functioning, and quality of life occur after PER. Identifying and counseling patients less likely to benefit from PER is an important future research direction.