Thirty-Day Readmissions After Chronic Total Occlusion Percutaneous Coronary Intervention in the United States: Insights From the Nationwide Readmissions Database.

BACKGROUND: Several studies have investigated early readmissions after percutaneous coronary interventions (PCIs). However, studies investigating 30-day readmission following PCI for chronic total occlusion (CTO) are lacking. METHODS: The National-Readmission-Database (NRD) was queried to identify patients undergoing elective CTO PCI between January 1, 2016 and December 31, 2016. We assessed the incidence, predictors, and cost of 30-day readmissions. RESULTS: A total of 30,579 CTO PCIs were identified in the NRD. After excluding patients who had acute myocardial infarction (n = 14,852), the final cohort included 15,907 patients. In this group of patients, 254 patients (1.5%) expired during their index admission and, 1600 patients (10%) had an unplanned readmission within 30 days. Cardiac causes constituted 54.2% of all causes of readmission. During the readmission, 15.8% of patients had coronary angiography, 8.4% underwent PCI, and 0.9% underwent bypass grafting. Independent predictors of 30-day readmission included baseline characteristics [age (OR 0.99, 95%CI 0.98-0.99), female (OR 1.14, 95%CI 1.01-1.28), lung disease (OR 1.36, 95%CI 1.20-1.55), heart failure (OR 1.42, 95%CI 1.24-1.62), anemia (OR 1.30, 95%CI 1.12-1.50), vascular disease (OR 1.18, 95%CI 1.03-1.35), history of stroke (OR 1.50, 95%CI 1.28-1.76) and the presence of a defibrillator (OR 1.68, 95%CI 1.39-2.03)], and procedural complications [acute kidney injury (OR 1.55, 95%CI 1.33-1.80) and gastrointestinal bleeding (OR 1.67, 95%CI 1.03-2.71)]. CONCLUSIONS: One-tenth of patients undergoing CTO PCI are readmitted within 30-days, mostly for cardiac causes. The majority undergo angiography but <10% receive revascularization. Certain patient and procedural characteristics independently predicted 30-day readmission.

In-Hospital Costs and Costs of Complications of Chronic Total Occlusion Angioplasty: Insights From the OPEN-CTO Registry.

OBJECTIVES: The aim of this study was to describe the costs of chronic total occlusion (CTO) percutaneous coronary intervention (PCI) and the association of complications during CTO PCI with costs and length of stay (LOS). BACKGROUND: CTO PCI generally requires more procedural resources and carries higher risk for complications than PCI of non-CTO vessels. The costs of CTO PCI using the hybrid approach have not been described, and no studies have examined the impact of complications on in-hospital costs and LOS in this population. METHODS: Costs were calculated for 964 patients in the 12-center OPEN-CTO (Outcomes, Patient Health Status, and Efficiency in Chronic Total Occlusion Hybrid Procedures) registry using prospectively collected resource utilization and billing data. Multivariate models were developed to estimate the incremental costs and LOS associated with complications. Attributable costs and LOS were calculated by multiplying the independent cost of each event by its frequency in the population. RESULTS: Mean costs for the index hospitalization were $17,048 ± 9,904; 14.5% of patients experienced at least 1 complication. Patients with complications had higher mean hospital costs (by $8,603) and LOS (by 1.5 days) than patients without complications. Seven complications were independently associated with increased costs and 6 with LOS; clinically significant perforation and myocardial infarction had the greatest attributable cost per patient. Overall, complications accounted for $911 per patient in hospital costs (5.3% of the total costs) and 0.2 days of additional LOS. CONCLUSIONS: Complications have a significant impact on both LOS and in-hospital costs for patients undergoing CTO PCI. Methods to identify high-risk patients and develop strategies to prevent complications may reduce CTO PCI costs.

Randomized Comparison of a CrossBoss First Versus Standard Wire Escalation Strategy for Crossing Coronary Chronic Total Occlusions: The CrossBoss First Trial.

OBJECTIVES: 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. BACKGROUND: There is equipoise about the optimal initial strategy for crossing 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 use. RESULTS: 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. 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 use and cost.

Determinants of high device cost in current percutaneous coronary interventions.

BACKGROUND: Percutaneous coronary interventions (PCI), especially medical devices, consume large amounts of medical resources. It is important to know which type of lesions requires high device costs among current PCI. The purpose of this study was to investigate the association between lesion characteristics and medical device costs in current PCI. METHODS: We identified 593 coronary artery lesions in our PCI database between January 1, 2015 and December 31, 2015. The total PCI cost was calculated for each lesion. The highest quartile (Q1) of total PCI costs was defined as the highest cost group, whereas the other quartiles (Q2, Q3, Q4) were defined as the low-intermediate cost group. RESULTS: The mean PCI cost in the highest cost and low-intermediate cost groups was ¥1,032,943 ±â€¯211,912 and ¥532,547 ±â€¯112,127, respectively. In a multivariate logistic regression analysis, lesion length (10 mm increase: OR 2.93, 95% CI 2.25-3.82, P < 0.001), left main lesion (OR 2.96, 95% CI 1.02-8.60, P = 0.046), moderate to severe calcification (OR 16.43, 95% CI 7.97-33.88, P < 0.001), chronic total occlusion (CTO) (OR 5.83, 95% CI 2.07-16.39, P = 0.001), and bifurcation (OR 2.01, 95% CI 1.08-3.75, P = 0.027) were significantly associated with the highest cost group. CONCLUSIONS: Lesion characteristics including CTO, diffuse long lesion, calcification, and bifurcation were significantly associated with the highest device cost. Non-CTO complex lesions including bifurcation and calcification as well as CTO lesions require higher PCI device costs than non-complex lesions.

The Outcomes, Patient Health Status, and Efficiency IN Chronic Total Occlusion Hybrid Procedures registry: rationale and design.

BACKGROUND: Patients with chronic total occlusions of a coronary artery represent a complex, yet common, clinical conundrum among patients with ischemic heart disease. Chronic total occlusion angioplasty is increasingly being used as a treatment for these complex lesions. There is a compelling need to better quantify the safety, efficacy, benefits, and costs of the procedure. METHODS: To address these gaps in knowledge, we designed the Outcomes, Patient Health Status, and Efficiency IN Chronic Total Occlusion Hybrid Procedures (OPEN CTO) study, an investigator-initiated multicenter, single-arm registry including 12 centers with a planned enrollment of 1000 patients. To ensure the accuracy of our observations, we used a unique auditing process through the National Cardiovascular Disease Registries' Cath/PCI Registry, angiographic core lab analysis, clinical events adjudication, and a systematic collection of patient-reported outcomes and costs. RESULTS: Between 21 January 2014 and 22 July 2015, 1000 patients were enrolled in OPEN CTO. A total of 28 patients either refused (N=26) or were missed by the screening process (N=2). In the National Cardiovascular Disease Registry Cath/PCI registry audit, there were 1096 chronic total occlusion-percutaneous coronary intervention procedures that were performed by participating operators during the time they enrolled in OPEN CTO. Overall, 987 of those patients could be definitively matched to an OPEN CTO enrolled patient (enrolled group). The remaining 109 were considered to be not enrolled in OPEN CTO (not enrolled group). Compared with the enrolled group, the patients in the nonenrolled group were less frequently of White race and more frequently of Hispanic origin. Procedural outcomes including National Cardiovascular Disease Registry-defined technical success, procedural success, and major adverse coronary events rates were similar. CONCLUSION: OPEN CTO is the most comprehensive and rigorously collected dataset to date that will provide unique insights into the success, safety, benefits, and the costs of chronic total occlusion-percutaneous coronary intervention using a reproducible technical approach to patients with these complex lesions.

Economic evaluation of percutaneous left atrial appendage occlusion, dabigatran, and warfarin for stroke prevention in patients with nonvalvular atrial fibrillation.

BACKGROUND: Percutaneous left atrial appendage (LAA) occlusion and novel pharmacological therapies are now available to manage stroke risk in patients with nonvalvular atrial fibrillation; however, the cost-effectiveness of LAA occlusion compared with dabigatran and warfarin in patients with nonvalvular atrial fibrillation is unknown. METHODS AND RESULTS: Cost-utility analysis using a patient-level Markov microsimulation decision analytic model with a lifetime horizon was undertaken to determine the lifetime costs, quality-adjusted life years, and incremental cost-effectiveness ratio of LAA occlusion in relation to dabigatran and warfarin in patients with nonvalvular atrial fibrillation at risk for stroke without contraindications to oral anticoagulation. The analysis was performed from the perspective of the Ontario Ministry of Health and Long Term Care, the third-party payer for insured health services in Ontario, Canada. Effectiveness and utility data were obtained from the published literature. Cost data were obtained from the Ontario Drug Benefits Formulary and the Ontario Case Costing Initiative. Warfarin therapy had the lowest discounted quality-adjusted life years at 4.55, followed by dabigatran at 4.64 and LAA occlusion at 4.68. The average discounted lifetime cost was $21 429 for a patient taking warfarin, $25 760 for a patient taking dabigatran, and $27 003 for LAA occlusion. Compared with warfarin, the incremental cost-effectiveness ratio for LAA occlusion was $41 565. Dabigatran was extendedly dominated. CONCLUSIONS: Percutaneous LAA occlusion represents a novel therapy for stroke reduction that is cost-effective compared with warfarin for patients at risk who have nonvalvular atrial fibrillation.

Development of a high-volume, multiple-operator program for percutaneous chronic total coronary occlusion revascularization: procedural, clinical, and cost-utilization outcomes.

BACKGROUND: Development of a specialized chronic total coronary occlusion (CTO) revascularization program attentive to procedural guidelines, quality oversight, and cost/resource utilization has not been described. METHODS: A single-center CTO interventional program was initiated with requirements including: extensive didactic training, on-site proctorship, routine determination of case appropriateness, adherence to procedural safety guidelines, and a 2-operator/case approach. Clinical and angiographic characteristics, procedural outcomes, in-hospital clinical events, and cost/resource utilization were examined. RESULTS: Among 145 patients, 160 consecutive CTO revascularization procedures were attempted between October 2009 and December 2010. Selected procedural and technical characteristics included: bilateral femoral access, 90.0%; planned retrograde guidewire placement, 37.5%; re-entry catheter, 10.0%; reattempt, 10.6%; fluoroscopic time, 67.4 ± 45.5 min; contrast volume, 403 ± 215 mL. Average stent number and total stent length per CTO vessel were 2.6 ± 1.1 and 64.7 ± 30.7 mm, respectively. Overall CTO success rate was 85.6% (137/160). In-hospital adverse outcomes included: death 0.6%; emergency bypass surgery, 0.6%; tamponade, 0.6%; myocardial infarction, 1.9%; transient nephropathy, 1.2%. Compared with patients undergoing non-CTO PCI, procedural and total cost per patient were significantly higher among the CTO cohort despite overall similar contribution margins ($5,173 ± 12,052 versus $5,730 ± 8,958, P = 0.58). CONCLUSIONS: Following initiation of a dedicated program with implementation of quality and performance guidelines, complex CTO revascularization may be safely performed with outcomes comparable with reports from established centers. Despite higher resource utilization, CTO revascularization is associated with a positive contribution margin. Requirement of educational and performance standards, mentorship from experts, consensus review for appropriateness and provision of catheterization laboratory policies may represent a model for program development.

Chronic total occlusion angioplasty in the United States.

Coronary chronic total occlusions (CTOs) are commonly encountered complex lesions identified in 15% of all patients referred for coronary angiography. Chronic total occlusion remains the most powerful predictor of referral for coronary bypass surgery. The benefits of CTO percutaneous coronary intervention (PCI) include symptom relief, improved left ventricular function, and potentially a survival advantage associated with success when compared with failed CTO-PCI. Data from the NCDR (National Cardiovascular Data Registry) suggest that CTO-PCI attempt rates in the U.S. have not changed over the past 5 years despite significant advances in techniques and technology, some of which we review here. Additionally, these data highlight a major disparity in attempt rates based on operator PCI volume. Remaining barriers to attempting CTO-PCI in the U.S. include operator inexperience, the perception of increased risk of CTO-PCI, and financial disincentives to operators and hospitals. To overcome operator inexperience, participation in CTO clubs, the invitation of guest operators, and a dedicated CTO day can be implemented at institutions committed to learning advanced CTO-PCI techniques so that operators can overcome the barriers and offer patients access to percutaneous therapy when it is clinically indicated.